Trial Outcomes & Findings for Study of Chokeberry to Reduce Cardiovascular Disease Risk in Former Smokers (NCT NCT01541826)
NCT ID: NCT01541826
Last Updated: 2017-07-11
Results Overview
Change in LDL cholesterol from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
COMPLETED
NA
62 participants
Baseline, 6 weeks, 12 weeks of intervention
2017-07-11
Participant Flow
Participant milestones
| Measure |
Color-matched Rice Powder Pill
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
Chokeberry extract capsule
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose.
|
Chaokeberry Extract Capsule (Acute)
Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose.
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
6
|
|
Overall Study
COMPLETED
|
24
|
25
|
6
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
0
|
Reasons for withdrawal
| Measure |
Color-matched Rice Powder Pill
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
Chokeberry extract capsule
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose.
|
Chaokeberry Extract Capsule (Acute)
Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
Baseline Characteristics
Missing value for one participant in acute study.
Baseline characteristics by cohort
| Measure |
Color-matched Rice Powder Pill
n=24 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=25 Participants
Chokeberry extract capsule
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
Chokeberry Extract Capsule (Acute)
n=6 Participants
Chokeberry extract capsule, acute: Chokeberry extract capsule, 2 x 250 mg, one-time dose.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
BMI
|
27.2 kg/m^2
STANDARD_DEVIATION 4.7 • n=24 Participants
|
25.7 kg/m^2
STANDARD_DEVIATION 5.0 • n=25 Participants
|
24.1 kg/m^2
STANDARD_DEVIATION 2.3 • n=6 Participants
|
26.5 kg/m^2
STANDARD_DEVIATION 4.9 • n=55 Participants
|
|
Waist circumference
|
86.0 cm
STANDARD_DEVIATION 17.1 • n=24 Participants
|
90.9 cm
STANDARD_DEVIATION 35.1 • n=25 Participants
|
79.4 cm
STANDARD_DEVIATION 8.4 • n=6 Participants
|
88.5 cm
STANDARD_DEVIATION 27.6 • n=55 Participants
|
|
Systolic blood pressure
|
121 mmHg
STANDARD_DEVIATION 14 • n=24 Participants
|
117 mmHg
STANDARD_DEVIATION 16 • n=25 Participants
|
111.3 mmHg
STANDARD_DEVIATION 7.7 • n=6 Participants
|
119 mmHg
STANDARD_DEVIATION 15 • n=55 Participants
|
|
Diastolic blood pressure
|
76.0 mmHg
STANDARD_DEVIATION 10.4 • n=24 Participants
|
75.3 mmHg
STANDARD_DEVIATION 12.0 • n=25 Participants
|
73.3 mmHg
STANDARD_DEVIATION 4.7 • n=6 Participants
|
75.6 mmHg
STANDARD_DEVIATION 11.0 • n=55 Participants
|
|
Total cholesterol
|
203 mg/dL
STANDARD_DEVIATION 36 • n=24 Participants
|
220 mg/dL
STANDARD_DEVIATION 63 • n=25 Participants
|
160 mg/dL
STANDARD_DEVIATION 30 • n=6 Participants
|
213 mg/dL
STANDARD_DEVIATION 51 • n=55 Participants
|
|
HDL-cholesterol
|
28.7 mg/dL
STANDARD_DEVIATION 6.1 • n=24 Participants
|
26.8 mg/dL
STANDARD_DEVIATION 7.6 • n=25 Participants
|
54.8 mg/dL
STANDARD_DEVIATION 15.7 • n=6 Participants
|
27.6 mg/dL
STANDARD_DEVIATION 6.9 • n=55 Participants
|
|
LDL-cholesterol
|
158 mg/dL
STANDARD_DEVIATION 30 • n=24 Participants
|
175 mg/dL
STANDARD_DEVIATION 54 • n=25 Participants
|
99.2 mg/dL
STANDARD_DEVIATION 19.2 • n=6 Participants
|
168 mg/dL
STANDARD_DEVIATION 44 • n=55 Participants
|
|
Triglycerides
|
82.1 mg/dL
STANDARD_DEVIATION 37.3 • n=24 Participants
|
89.6 mg/dL
STANDARD_DEVIATION 45.4 • n=25 Participants
|
69.2 mg/dL
STANDARD_DEVIATION 27.1 • n=6 Participants
|
86.3 mg/dL
STANDARD_DEVIATION 41.0 • n=55 Participants
|
|
Total cholesterol/HDL cholesterol
|
7.3 dimensionless ratio
STANDARD_DEVIATION 1.5 • n=24 Participants
|
8.5 dimensionless ratio
STANDARD_DEVIATION 2.7 • n=25 Participants
|
3.2 dimensionless ratio
STANDARD_DEVIATION 0.7 • n=6 Participants
|
8.0 dimensionless ratio
STANDARD_DEVIATION 2.3 • n=55 Participants
|
|
Age, Continuous
|
37.4 years
STANDARD_DEVIATION 14.8 • n=24 Participants
|
32.6 years
STANDARD_DEVIATION 12.7 • n=25 Participants
|
31.3 years
STANDARD_DEVIATION 12.8 • n=6 Participants
|
34.9 years
STANDARD_DEVIATION 13.9 • n=55 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=24 Participants
|
12 Participants
n=25 Participants
|
3 Participants
n=6 Participants
|
28 Participants
n=55 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=24 Participants
|
13 Participants
n=25 Participants
|
3 Participants
n=6 Participants
|
27 Participants
n=55 Participants
|
|
Height
|
1.73 m
STANDARD_DEVIATION 0.92 • n=24 Participants
|
1.71 m
STANDARD_DEVIATION 0.83 • n=25 Participants
|
1.74 m
STANDARD_DEVIATION 0.97 • n=6 Participants
|
1.72 m
STANDARD_DEVIATION 0.87 • n=55 Participants
|
|
Average years of smoking
|
14.9 years
STANDARD_DEVIATION 11.9 • n=24 Participants • Missing value for one participant in acute study.
|
8.96 years
STANDARD_DEVIATION 6.68 • n=25 Participants • Missing value for one participant in acute study.
|
4.8 years
STANDARD_DEVIATION 3.0 • n=5 Participants • Missing value for one participant in acute study.
|
11.9 years
STANDARD_DEVIATION 10.0 • n=54 Participants • Missing value for one participant in acute study.
|
|
Degree of past smoking
3-5 cigarettes/day
|
2 Participants
n=24 Participants • Missing value for one participant in acute study.
|
4 Participants
n=25 Participants • Missing value for one participant in acute study.
|
1 Participants
n=5 Participants • Missing value for one participant in acute study.
|
7 Participants
n=54 Participants • Missing value for one participant in acute study.
|
|
Degree of past smoking
6-10 cigarettes/day
|
4 Participants
n=24 Participants • Missing value for one participant in acute study.
|
7 Participants
n=25 Participants • Missing value for one participant in acute study.
|
1 Participants
n=5 Participants • Missing value for one participant in acute study.
|
12 Participants
n=54 Participants • Missing value for one participant in acute study.
|
|
Degree of past smoking
11-15 cigarettes/day
|
4 Participants
n=24 Participants • Missing value for one participant in acute study.
|
4 Participants
n=25 Participants • Missing value for one participant in acute study.
|
2 Participants
n=5 Participants • Missing value for one participant in acute study.
|
10 Participants
n=54 Participants • Missing value for one participant in acute study.
|
|
Degree of past smoking
16-20 cigarettes/day
|
11 Participants
n=24 Participants • Missing value for one participant in acute study.
|
6 Participants
n=25 Participants • Missing value for one participant in acute study.
|
0 Participants
n=5 Participants • Missing value for one participant in acute study.
|
17 Participants
n=54 Participants • Missing value for one participant in acute study.
|
|
Degree of past smoking
>20 cigarettes/day
|
3 Participants
n=24 Participants • Missing value for one participant in acute study.
|
4 Participants
n=25 Participants • Missing value for one participant in acute study.
|
1 Participants
n=5 Participants • Missing value for one participant in acute study.
|
8 Participants
n=54 Participants • Missing value for one participant in acute study.
|
|
Weight
|
81.5 kg
STANDARD_DEVIATION 17.2 • n=24 Participants
|
77.2 kg
STANDARD_DEVIATION 21.1 • n=25 Participants
|
72.8 kg
STANDARD_DEVIATION 9.5 • n=6 Participants
|
79.3 kg
STANDARD_DEVIATION 19.2 • n=55 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 weeks, 12 weeks of interventionPopulation: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Change in LDL cholesterol from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=24 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=25 Participants
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
LDL Cholesterol
6 weeks
|
0.9 mg/dL
Standard Error 4.2
|
-12.6 mg/dL
Standard Error 5.3
|
|
LDL Cholesterol
12 weeks
|
-0.4 mg/dL
Standard Error 5.9
|
-18.5 mg/dL
Standard Error 7.8
|
SECONDARY outcome
Timeframe: 6 and 12 weeks after supplementationPopulation: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Change in fasting total cholesterol from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=24 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=25 Participants
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
Total Cholesterol
Baseline
|
203 mg/dL
Standard Error 7
|
220 mg/dL
Standard Error 13
|
|
Total Cholesterol
6 weeks (change from baseline)
|
-0.1 mg/dL
Standard Error 4.6
|
1.4 mg/dL
Standard Error 2.5
|
|
Total Cholesterol
12 weeks (change from baseline)
|
-1.3 mg/dL
Standard Error 6.4
|
-17.9 mg/dL
Standard Error 7.6
|
SECONDARY outcome
Timeframe: 6 and 12 weeks after supplementationPopulation: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Change in fasting plasma cholesterol from baseline after chronic supplemenation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=24 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=25 Participants
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
HDL-cholesterol
Baseline
|
28.8 mg/dL
Standard Error 1.3
|
26.8 mg/dL
Standard Error 1.5
|
|
HDL-cholesterol
6 weeks (change from baseline)
|
-0.9 mg/dL
Standard Error 1.0
|
0.2 mg/dL
Standard Error 0.8
|
|
HDL-cholesterol
12 weeks (change from baseline)
|
-0.7 mg/dL
Standard Error 1.4
|
0.2 mg/dL
Standard Error 0.8
|
SECONDARY outcome
Timeframe: 6 and 12 weeks after supplementationPopulation: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Change in fasting plasma triglycerides from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=24 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=25 Participants
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
Triglycerides
Baseline
|
82.1 mg/dL
Standard Error 7.6
|
89.6 mg/dL
Standard Error 9.0
|
|
Triglycerides
6 weeks (change from baseline)
|
-0.6 mg/dL
Standard Error 2.7
|
1.0 mg/dL
Standard Error 5.9
|
|
Triglycerides
12 weeks (change from baseline)
|
-1.0 mg/dL
Standard Error 5.9
|
2.0 mg/dL
Standard Error 8.5
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, and 12 weeks following interventionPopulation: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Change in resting systolic blood pressure after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=24 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=25 Participants
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
Resting Systolic Blood Pressure
Baseline
|
121 mmHg
Standard Error 3
|
117 mmHg
Standard Error 3
|
|
Resting Systolic Blood Pressure
6 weeks (change from baseline)
|
-0.8 mmHg
Standard Error 1.5
|
2.8 mmHg
Standard Error 1.7
|
|
Resting Systolic Blood Pressure
12 weeks (change from baseline)
|
0.2 mmHg
Standard Error 2.9
|
1.2 mmHg
Standard Error 2.4
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, and 12 weeks following interventionPopulation: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Change in resting diastolic blood pressure after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=24 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=25 Participants
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
Resting Diastolic Blood Pressure
Baseline
|
76.0 mmHg
Standard Error 2.1
|
75.3 mmHg
Standard Error 2.4
|
|
Resting Diastolic Blood Pressure
6 weeks (change from baseline)
|
-1.2 mmHg
Standard Error 2.4
|
5.0 mmHg
Standard Error 1.3
|
|
Resting Diastolic Blood Pressure
12 weeks (change from baseline)
|
-1.1 mmHg
Standard Error 1.7
|
2.0 mmHg
Standard Error 1.5
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks following interventionPopulation: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Change in resting urinary F2-isoprostanes after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=24 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=25 Participants
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
Urinary F2-isoprostanes
Baseline
|
71.0 ng/mmol creatinine
Standard Error 8.1
|
58.6 ng/mmol creatinine
Standard Error 7.0
|
|
Urinary F2-isoprostanes
12 weeks
|
81.6 ng/mmol creatinine
Standard Error 7.8
|
68.4 ng/mmol creatinine
Standard Error 9.0
|
SECONDARY outcome
Timeframe: Baseline, 12 wkPopulation: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Monocyte messenger ribonucleic acid (mRNA) expression normalized to glyceraldehyde-3-phosphate dehydrogenase (GAPDH) after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=24 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=25 Participants
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
3-hydroxy-3-methyl-glutaryl Coenzyme A Reductase (HMGR)
Baseline
|
0.90 relative expression (HMGR/GAPDH)
Standard Error 0.06
|
0.91 relative expression (HMGR/GAPDH)
Standard Error 0.06
|
|
3-hydroxy-3-methyl-glutaryl Coenzyme A Reductase (HMGR)
12 weeks
|
1.16 relative expression (HMGR/GAPDH)
Standard Error 0.28
|
0.79 relative expression (HMGR/GAPDH)
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Change from baseline at 12 weeksPopulation: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Monocyte LDL receptor mRNA normalized to glyceraldehyde-3-phosphate dehydrogenase after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=24 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=25 Participants
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
LDL Receptor (LDLR)
Baseline
|
0.90 relative expression (LDLR/GAPDH)
Standard Error 0.07
|
0.84 relative expression (LDLR/GAPDH)
Standard Error 0.07
|
|
LDL Receptor (LDLR)
12 weeks
|
0.93 relative expression (LDLR/GAPDH)
Standard Error 0.22
|
0.88 relative expression (LDLR/GAPDH)
Standard Error 0.26
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Monocyte LDL receptor protein by Western blot, normalized to β-actin after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=24 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=25 Participants
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
LDL Receptor (LDLR) Protein
Baseline
|
1.71 relative expression (LDLR/β-actin)
Standard Error 0.33
|
1.45 relative expression (LDLR/β-actin)
Standard Error 0.06
|
|
LDL Receptor (LDLR) Protein
12 weeks
|
2.47 relative expression (LDLR/β-actin)
Standard Error 0.80
|
1.45 relative expression (LDLR/β-actin)
Standard Error 0.64
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 4, 6, 9, 12, and 24 hours following dosePopulation: Not determined in chronic arms (Color-matched Rice Powder Pill or Chokeberry Extract Capsule) as this analysis required additional collection time-points that were not utilized in the other arms.
Plasma area under the curve of chokeberry polyphenols and their metabolites. Measurement (time 0) began at study baseline. Not determined in chronic arms (Color-matched Rice Powder Pill or Chokeberry Extract Capsule).
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=6 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
Plasma Area Under the Curve of Chokeberry Polyphenols and Their Metabolites.
Protocatechuic acid
|
0.054 micrograms x h/mL
Standard Error 0.013
|
—
|
|
Plasma Area Under the Curve of Chokeberry Polyphenols and Their Metabolites.
Hippuric acid
|
22.350 micrograms x h/mL
Standard Error 4.441
|
—
|
|
Plasma Area Under the Curve of Chokeberry Polyphenols and Their Metabolites.
3-(4-Hydroxyphenyl)propionic acid
|
2.725 micrograms x h/mL
Standard Error 2.391
|
—
|
|
Plasma Area Under the Curve of Chokeberry Polyphenols and Their Metabolites.
Cyanidin-3-O-glucoside
|
0.462 micrograms x h/mL
Standard Error 0.170
|
—
|
|
Plasma Area Under the Curve of Chokeberry Polyphenols and Their Metabolites.
Peonidin-3-O-galactoside
|
0.627 micrograms x h/mL
Standard Error 0.198
|
—
|
SECONDARY outcome
Timeframe: 0 to 24 h after consumption of extractPopulation: Not determined in chronic arms (Color-matched Rice Powder Pill or Chokeberry Extract Capsule) as this analysis required additional collection time-points that were not utilized in the other arms.
Urinary excretion of polyphenols, from 0 to 24 h after consumption of extract, area under the curve (AUC) in Chokeberry Extract Capsule (acute) arm only.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=6 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
Urinary Excretion of Polyphenols
Protocatechuic acid
|
3.682 mg x h/mg creatinine
Standard Error 0.587
|
—
|
|
Urinary Excretion of Polyphenols
3,4-dihyrdoxyphenylacetic acid
|
11.426 mg x h/mg creatinine
Standard Error 0.881
|
—
|
|
Urinary Excretion of Polyphenols
Hippuric acid
|
2429.852 mg x h/mg creatinine
Standard Error 360.197
|
—
|
|
Urinary Excretion of Polyphenols
3-(4-hydroxyphenyl)propionic acid
|
2.299 mg x h/mg creatinine
Standard Error 0.715
|
—
|
|
Urinary Excretion of Polyphenols
Cyanidin-3-O-galactoside
|
0.016 mg x h/mg creatinine
Standard Error 0.005
|
—
|
|
Urinary Excretion of Polyphenols
Cyanidin-3-O-glucoside
|
0.118 mg x h/mg creatinine
Standard Error 0.070
|
—
|
|
Urinary Excretion of Polyphenols
Cyanidin-3-O-arabinoside
|
0.088 mg x h/mg creatinine
Standard Error 0.031
|
—
|
|
Urinary Excretion of Polyphenols
Peonidin-3-O-galactoside
|
0.053 mg x h/mg creatinine
Standard Error 0.012
|
—
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 12 weeksPopulation: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Fasting plasma adiponectin after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=24 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=25 Participants
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
Adiponectin
Baseline
|
13.2 micrograms/mL
Standard Error 1.9
|
12.8 micrograms/mL
Standard Error 1.5
|
|
Adiponectin
6 weeks
|
14.2 micrograms/mL
Standard Error 2.0
|
13.8 micrograms/mL
Standard Error 1.7
|
|
Adiponectin
12 weeks
|
12.5 micrograms/mL
Standard Error 1.6
|
13.2 micrograms/mL
Standard Error 1.5
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 12 weeksPopulation: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Fasting plasma interleukin-1 beta after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=24 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=25 Participants
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
Interleukin-1 Beta
Baseline
|
9.3 pg/mL
Standard Error 2.4
|
16.2 pg/mL
Standard Error 8.6
|
|
Interleukin-1 Beta
6 weeks
|
9.5 pg/mL
Standard Error 2.7
|
17.0 pg/mL
Standard Error 9.7
|
|
Interleukin-1 Beta
12 weeks
|
10.1 pg/mL
Standard Error 3.0
|
14.7 pg/mL
Standard Error 7.4
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 12 weeksPopulation: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Fasting plasma interleukin-6 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=24 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=25 Participants
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
Interleukin-6
Baseline
|
1.94 pg/mL
Standard Error 0.34
|
4.68 pg/mL
Standard Error 1.34
|
|
Interleukin-6
6 weeks
|
1.87 pg/mL
Standard Error 0.38
|
5.16 pg/mL
Standard Error 1.54
|
|
Interleukin-6
12 weeks
|
1.76 pg/mL
Standard Error 0.29
|
5.34 pg/mL
Standard Error 1.52
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 12 weeksPopulation: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Fasting plasma monocyte chemoattractant protein-1 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=24 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=25 Participants
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
Monocyte Chemoattractant Protein-1
Baseline
|
97 pg/mL
Standard Error 6
|
133 pg/mL
Standard Error 31
|
|
Monocyte Chemoattractant Protein-1
6 weeks
|
96 pg/mL
Standard Error 5
|
167 pg/mL
Standard Error 43
|
|
Monocyte Chemoattractant Protein-1
12 weeks
|
91 pg/mL
Standard Error 5
|
141 pg/mL
Standard Error 27
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 12 weeksPopulation: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Fasting plasma Tumor necrosis factor-alpha after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=24 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=25 Participants
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
Tumor Necrosis Factor-alpha
Baseline
|
4.36 pg/mL
Standard Error 1.83
|
5.90 pg/mL
Standard Error 1.63
|
|
Tumor Necrosis Factor-alpha
6 weeks
|
4.70 pg/mL
Standard Error 1.89
|
6.44 pg/mL
Standard Error 1.83
|
|
Tumor Necrosis Factor-alpha
12 weeks
|
4.86 pg/mL
Standard Error 1.85
|
6.10 pg/mL
Standard Error 1.72
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 12 weeksPopulation: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Fasting plasma C-reactive protein after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=24 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=25 Participants
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
C-reactive Protein
Baseline
|
2.54 pg/mL
Standard Error 0.60
|
2.01 pg/mL
Standard Error 0.34
|
|
C-reactive Protein
6 weeks
|
2.18 pg/mL
Standard Error 0.42
|
2.32 pg/mL
Standard Error 0.39
|
|
C-reactive Protein
12 weeks
|
2.24 pg/mL
Standard Error 0.38
|
2.29 pg/mL
Standard Error 0.49
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 12 weeksPopulation: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Fasting plasma intercellular adhesion molecule 1 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=24 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=25 Participants
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
Intercellular Adhesion Molecule 1
Baseline
|
97.1 ng/mL
Standard Error 7.2
|
96.6 ng/mL
Standard Error 5.4
|
|
Intercellular Adhesion Molecule 1
6 weeks
|
97.6 ng/mL
Standard Error 7.2
|
99.4 ng/mL
Standard Error 5.7
|
|
Intercellular Adhesion Molecule 1
12 weeks
|
100 ng/mL
Standard Error 8
|
97.5 ng/mL
Standard Error 5.8
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 12 weeksPopulation: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Fasting plasma soluble vascular cell adhesion molecule 1 after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=24 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=25 Participants
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
Soluble Vascular Cell Adhesion Molecule 1
Baseline
|
585 ng/mL
Standard Deviation 23
|
601 ng/mL
Standard Deviation 31
|
|
Soluble Vascular Cell Adhesion Molecule 1
6 weeks
|
604 ng/mL
Standard Deviation 23
|
622 ng/mL
Standard Deviation 31
|
|
Soluble Vascular Cell Adhesion Molecule 1
12 weeks
|
604 ng/mL
Standard Deviation 26
|
599 ng/mL
Standard Deviation 27
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 12 weeksPopulation: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Fasting plasma P-selectin after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=24 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=25 Participants
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
P-selectin
Baseline
|
130 ng/mL
Standard Error 13
|
124 ng/mL
Standard Error 12
|
|
P-selectin
6 weeks
|
111 ng/mL
Standard Error 11
|
127 ng/mL
Standard Error 12
|
|
P-selectin
12 weeks
|
131 ng/mL
Standard Error 11
|
145 ng/mL
Standard Error 17
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 12 weeksPopulation: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Fasting plasma total antioxidant capacity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=24 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=25 Participants
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
Total Antioxidant Capacity
Baseline
|
210 micrograms vitamin C equivalents/mL
Standard Error 4
|
208 micrograms vitamin C equivalents/mL
Standard Error 3
|
|
Total Antioxidant Capacity
6 weeks
|
214 micrograms vitamin C equivalents/mL
Standard Error 3
|
211 micrograms vitamin C equivalents/mL
Standard Error 3
|
|
Total Antioxidant Capacity
12 weeks
|
209 micrograms vitamin C equivalents/mL
Standard Error 4
|
207 micrograms vitamin C equivalents/mL
Standard Error 4
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 12 weeksPopulation: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Catalase activity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=24 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=25 Participants
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
Catalase Activity
Baseline
|
41.7 nmol/min/mL
Standard Error 1.4
|
41.1 nmol/min/mL
Standard Error 2.1
|
|
Catalase Activity
6 weeks
|
35.5 nmol/min/mL
Standard Error 1.2
|
38.7 nmol/min/mL
Standard Error 1.5
|
|
Catalase Activity
12 weeks
|
41.7 nmol/min/mL
Standard Error 2.3
|
41.2 nmol/min/mL
Standard Error 1.8
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 12 weeksPopulation: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Fasting plasma glutathione peroxidase activity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=24 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=25 Participants
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
Glutathione Peroxidase Activity
Baseline
|
2550 nmol/min/mL
Standard Error 140
|
2550 nmol/min/mL
Standard Error 140
|
|
Glutathione Peroxidase Activity
6 weeks
|
2560 nmol/min/mL
Standard Error 130
|
2500 nmol/min/mL
Standard Error 160
|
|
Glutathione Peroxidase Activity
12 weeks
|
2470 nmol/min/mL
Standard Error 110
|
2650 nmol/min/mL
Standard Error 190
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 12 weeksPopulation: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Fasting plasma superoxide dismutase after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=24 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=25 Participants
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
Superoxide Dismutase Activity
Baseline
|
1190 units/mL
Standard Error 50
|
1180 units/mL
Standard Error 40
|
|
Superoxide Dismutase Activity
6 weeks
|
1190 units/mL
Standard Error 50
|
1160 units/mL
Standard Error 40
|
|
Superoxide Dismutase Activity
12 weeks
|
1160 units/mL
Standard Error 60
|
1160 units/mL
Standard Error 40
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Overnight urinary polyphenol excretion after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=24 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=25 Participants
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
Urinary Polyphenol Excretion
Protocatechuic acid
|
1.38 mg/mg creatinine
Interval 0.94 to 2.08
|
1.20 mg/mg creatinine
Interval 0.64 to 2.03
|
|
Urinary Polyphenol Excretion
3,4-dihydroxyphenylacetic acid
|
5.04 mg/mg creatinine
Interval 2.36 to 7.45
|
4.56 mg/mg creatinine
Interval 2.18 to 9.09
|
|
Urinary Polyphenol Excretion
Hippuric acid
|
133 mg/mg creatinine
Interval 104.0 to 234.0
|
138 mg/mg creatinine
Interval 62.0 to 292.0
|
|
Urinary Polyphenol Excretion
Ferulic acid
|
0.68 mg/mg creatinine
Interval 0.24 to 1.2
|
0.71 mg/mg creatinine
Interval 0.23 to 3.57
|
|
Urinary Polyphenol Excretion
3-(4-hydroxyphenyl)propionic acid
|
3.91 mg/mg creatinine
Interval 0.0 to 9.95
|
3.36 mg/mg creatinine
Interval 0.0 to 9.68
|
|
Urinary Polyphenol Excretion
Cyanidin-3-O-glucoside
|
0 mg/mg creatinine
Interval 0.0 to 0.055
|
0.00907 mg/mg creatinine
Interval 0.0 to 0.1993
|
|
Urinary Polyphenol Excretion
Cyanidin-3-O-galactoside
|
0 mg/mg creatinine
Interval 0.0 to 0.014
|
0.00466 mg/mg creatinine
Interval 0.0 to 0.0341
|
|
Urinary Polyphenol Excretion
Cyanidin-3-O-arabinoside
|
0 mg/mg creatinine
Interval 0.0 to 0.011
|
0 mg/mg creatinine
Interval 0.0 to 0.053
|
|
Urinary Polyphenol Excretion
Peonidin-3-O-galactoside
|
0 mg/mg creatinine
Interval 0.0 to 0.0
|
0.008 mg/mg creatinine
Interval 0.0 to 0.0106
|
|
Urinary Polyphenol Excretion
Sum anthocyanins
|
0.014 mg/mg creatinine
Interval 0.0 to 0.091
|
0.134 mg/mg creatinine
Interval 0.028 to 0.442
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Survey data were not available for two participants in the "Color-matched rice powder pill" group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Energy-adjusted intake based on 3-day dietary recalls, determined by the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=22 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=25 Participants
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
Energy-adjusted Nutrient Intake: Carbohydrate, Protein, Fat, Fiber
Carbohydrate
|
238 g/day
Standard Error 9
|
241 g/day
Standard Error 9
|
|
Energy-adjusted Nutrient Intake: Carbohydrate, Protein, Fat, Fiber
Protein
|
89.2 g/day
Standard Error 3.3
|
90.3 g/day
Standard Error 3.1
|
|
Energy-adjusted Nutrient Intake: Carbohydrate, Protein, Fat, Fiber
Fat
|
27.8 g/day
Standard Error 4.0
|
77.6 g/day
Standard Error 29.5
|
|
Energy-adjusted Nutrient Intake: Carbohydrate, Protein, Fat, Fiber
Fiber
|
23.5 g/day
Standard Error 1.6
|
21.0 g/day
Standard Error 1.5
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Survey data were not available for two participants in the "Color-matched rice powder pill" group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Energy intake reported from 3-day dietary recalls at baseline and 12 weeks, determined by the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=22 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=25 Participants
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
Energy Intake
|
2230 kcal/d
Standard Error 735
|
1950 kcal/d
Standard Error 530
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Survey data were not available for two participants in the "Color-matched rice powder pill" group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Energy-adjusted micronutrient intake from 3-day dietary recalls at baseline and 12 weeks. Values reported as the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=22 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=25 Participants
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
Energy-adjusted Micronutrient Intake
Sodium
|
3490 mg/day
Standard Error 160
|
3480 mg/day
Standard Error 150
|
|
Energy-adjusted Micronutrient Intake
Calcium
|
947 mg/day
Standard Error 58
|
1070 mg/day
Standard Error 50
|
|
Energy-adjusted Micronutrient Intake
Iron
|
16.9 mg/day
Standard Error 1.3
|
16.9 mg/day
Standard Error 1.2
|
|
Energy-adjusted Micronutrient Intake
Vitamin D
|
5.0 mg/day
Standard Error 0.9
|
7.1 mg/day
Standard Error 0.8
|
|
Energy-adjusted Micronutrient Intake
Vitamin C
|
80.9 mg/day
Standard Error 12.9
|
90.9 mg/day
Standard Error 12.1
|
|
Energy-adjusted Micronutrient Intake
Vitamin E
|
10.6 mg/day
Standard Error 1.1
|
10.8 mg/day
Standard Error 1.1
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Survey data were not available for two participants in the "Color-matched rice powder pill" group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Energy-adjusted polyphenol intake assessed by 3-day dietary recalls at baseline and 12 weeks, values determined by average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=22 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=25 Participants
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
Polyphenol Intake
Isoflavones
|
3.9 mg/day
Standard Error 2.7
|
8.5 mg/day
Standard Error 2.6
|
|
Polyphenol Intake
Flavanols
|
73.9 mg/day
Standard Error 20.0
|
81.7 mg/day
Standard Error 18.7
|
|
Polyphenol Intake
Flavones
|
54.1 mg/day
Standard Error 29.1
|
50.3 mg/day
Standard Error 27.2
|
|
Polyphenol Intake
Flavanones
|
28.8 mg/day
Standard Error 11.4
|
22.4 mg/day
Standard Error 10.7
|
|
Polyphenol Intake
Flavan-3-ols
|
20.6 mg/day
Standard Error 7.4
|
26.0 mg/day
Standard Error 6.9
|
|
Polyphenol Intake
Anthocyanins
|
18.2 mg/day
Standard Error 5.2
|
26.6 mg/day
Standard Error 4.8
|
|
Polyphenol Intake
Proanthocyanidins
|
222 mg/day
Standard Error 162
|
418 mg/day
Standard Error 150
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Survey data were not available for two participants in the "Color-matched rice powder pill" group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Energy-adjusted intake of dietary antioxidant capacity determined by 3-day dietary recalls at baseline and 12 weeks. Values reported as average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=22 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=24 Participants
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
Intake of Dietary Antioxidant Capacity
|
417 Vitamin C equivalents
Standard Error 95
|
292 Vitamin C equivalents
Standard Error 89
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Survey data were not available for two participants in the "Color-matched rice powder pill" group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Energy-adjusted vitamin A intake from 3-day dietary recalls at baseline and 12 weeks. Values reported as the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.
Outcome measures
| Measure |
Color-matched Rice Powder Pill
n=22 Participants
Color-matched rice powder pill
Placebo capsule: Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
|
Chokeberry Extract Capsule
n=25 Participants
Chokeberry Extract: Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
|
|---|---|---|
|
Energy-adjusted Vitamin A Intake
|
3280 retinol equivalent mcg/day
Standard Error 740
|
2690 retinol equivalent mcg/day
Standard Error 690
|
Adverse Events
Color-matched Rice Powder Pill
Chokeberry Extract Capsule
Chokeberry Extract Capsule (Acute)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Bradley Bolling
University of Wisconsin-Madison, Department of Food Science
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place