Trial Outcomes & Findings for Impacts of a Combined Berry Extract Supplement on Vascular Function and Oxygen Utility Capacity in Young Adults (NCT NCT04312022)
NCT ID: NCT04312022
Last Updated: 2024-02-06
Results Overview
Endothelial function was measured using flow-mediated dilation in percents (%). A higher value represents a better outcome. Scale range for endothelial function is approximately 8-12% for healthy populations.
COMPLETED
NA
18 participants
1 day
2024-02-06
Participant Flow
A total of 18 participants completed this study and participated in both arms (berry extract and placebo) in a randomized crossover study design with a 2 wk washout period.
Participant milestones
| Measure |
Berry Extract, Then Placebo
Participants first received a single dose of berry extract supplementation (Hawthorn extract 465mg, Tart cherry powder 480mg, and Bromelain 400mg). After a 2 week washout period, they then received a single dose of placebo (tapioca powder).
|
Placebo, Then Berry Extract
Participants first received a single dose of placebo (tapioca powder). After a 2 week washout period, they then received a single dose of berry extract supplementation (Hawthorn extract 465mg, Tart cherry powder 480mg, and Bromelain 400mg).
|
|---|---|---|
|
First Intervention (1 Day)
STARTED
|
9
|
9
|
|
First Intervention (1 Day)
COMPLETED
|
9
|
9
|
|
First Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
|
Washout (2 Weeks)
STARTED
|
9
|
9
|
|
Washout (2 Weeks)
COMPLETED
|
9
|
9
|
|
Washout (2 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (1 Day)
STARTED
|
9
|
9
|
|
Second Intervention (1 Day)
COMPLETED
|
9
|
9
|
|
Second Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Berry Extract, Then Placebo
n=9 Participants
Participants first received a single dose of berry extract supplementation (Hawthorn extract 465mg, Tart cherry powder 480mg, and Bromelain 400mg). After a 2 week washout period, they then received a single dose of placebo (tapioca powder).
|
Placebo, Then Berry Extract
n=9 Participants
Participants first received a single dose of placebo (tapioca powder). After a 2 week washout period, they then received a single dose of berry extract supplementation (Hawthorn extract 465mg, Tart cherry powder 480mg, and Bromelain 400mg).
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.3 years
STANDARD_DEVIATION 4.2 • n=9 Participants
|
24.2 years
STANDARD_DEVIATION 4.1 • n=9 Participants
|
24.8 years
STANDARD_DEVIATION 4 • n=18 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=9 Participants
|
6 Participants
n=9 Participants
|
9 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=9 Participants
|
3 Participants
n=9 Participants
|
9 Participants
n=18 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body height
|
174.06 centimeters
STANDARD_DEVIATION 6.1 • n=9 Participants
|
172.4 centimeters
STANDARD_DEVIATION 7.0 • n=9 Participants
|
173.3 centimeters
STANDARD_DEVIATION 6.2 • n=18 Participants
|
|
Body mass
|
76.7 kilograms
STANDARD_DEVIATION 9.5 • n=9 Participants
|
76.8 kilograms
STANDARD_DEVIATION 13.1 • n=9 Participants
|
76.8 kilograms
STANDARD_DEVIATION 10.8 • n=18 Participants
|
|
Body composition (body fat percentage)
|
18.3 percentage of body fat
STANDARD_DEVIATION 4.4 • n=9 Participants
|
24.1 percentage of body fat
STANDARD_DEVIATION 5.4 • n=9 Participants
|
21.2 percentage of body fat
STANDARD_DEVIATION 5.5 • n=18 Participants
|
PRIMARY outcome
Timeframe: 1 dayEndothelial function was measured using flow-mediated dilation in percents (%). A higher value represents a better outcome. Scale range for endothelial function is approximately 8-12% for healthy populations.
Outcome measures
| Measure |
Berry Extract Intake
n=18 Participants
Intake of a berry extract supplement (hawthorn berry extract, tart cherry extract, and bromelain)
Berry extract: Berry extract supplement (hawthorn berry extract, tart cherry extract, bromelain)
|
Placebo Intake
n=18 Participants
Intake of a placebo (flour capsule)
Placebo: Placebo (flour capsule)
|
|---|---|---|
|
Endothelial Function
|
11.7 percent dilation
Standard Deviation 2.9
|
8.2 percent dilation
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: 1 daySystolic blood pressure was measured as millimeters of mercury (mmHg). Higher values represent a worse outcome. Scale range for systolic blood pressure is approximately 110-129 for most healthy populations.
Outcome measures
| Measure |
Berry Extract Intake
n=18 Participants
Intake of a berry extract supplement (hawthorn berry extract, tart cherry extract, and bromelain)
Berry extract: Berry extract supplement (hawthorn berry extract, tart cherry extract, bromelain)
|
Placebo Intake
n=18 Participants
Intake of a placebo (flour capsule)
Placebo: Placebo (flour capsule)
|
|---|---|---|
|
Systolic Blood Pressure
|
110.0 millimeters of mercury
Standard Deviation 10.0
|
112.5 millimeters of mercury
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: 1 dayDiastolic blood pressure was measured as millimeters of mercury (mmHg). Higher values represent a worse outcome. Scale range for systolic blood pressure is approximately 70-79 mmHg for most healthy populations.
Outcome measures
| Measure |
Berry Extract Intake
n=18 Participants
Intake of a berry extract supplement (hawthorn berry extract, tart cherry extract, and bromelain)
Berry extract: Berry extract supplement (hawthorn berry extract, tart cherry extract, bromelain)
|
Placebo Intake
n=18 Participants
Intake of a placebo (flour capsule)
Placebo: Placebo (flour capsule)
|
|---|---|---|
|
Diastolic Blood Pressure
|
72.8 millimeters of mercury
Standard Deviation 7.0
|
72.4 millimeters of mercury
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: 1 dayOxygen utility capacity was measured as tissue saturation index in percent (%). Higher values represent a better outcome. Scale range for tissue saturation index (TSI) is approximately 60-90% for most healthy populations at rest.
Outcome measures
| Measure |
Berry Extract Intake
n=18 Participants
Intake of a berry extract supplement (hawthorn berry extract, tart cherry extract, and bromelain)
Berry extract: Berry extract supplement (hawthorn berry extract, tart cherry extract, bromelain)
|
Placebo Intake
n=18 Participants
Intake of a placebo (flour capsule)
Placebo: Placebo (flour capsule)
|
|---|---|---|
|
Oxygen Utility Capacity (Tissue Saturation Index)
|
71.5 percent
Standard Deviation 10.4
|
64.3 percent
Standard Deviation 24.3
|
SECONDARY outcome
Timeframe: 1 dayIndex of fatigue during leg extension exercise. A lower value represents a better outcome. Scale range is \~15 - 35% for most healthy populations.
Outcome measures
| Measure |
Berry Extract Intake
n=18 Participants
Intake of a berry extract supplement (hawthorn berry extract, tart cherry extract, and bromelain)
Berry extract: Berry extract supplement (hawthorn berry extract, tart cherry extract, bromelain)
|
Placebo Intake
n=18 Participants
Intake of a placebo (flour capsule)
Placebo: Placebo (flour capsule)
|
|---|---|---|
|
Exercise Fatigue Index During Leg Extension
|
27.4 percent fatigue
Standard Deviation 11.0
|
25.0 percent fatigue
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: 1 dayFatigue index was quantified during isokinetic contraction of the participants dominant leg before and after berry extract and placebo intake using an isokinetic dynamometer. Test consisted of mild resistance at 240°/s to induce and measure muscular fatigue. Fatigue index = (initial peak torque - final peak torque)/initial peak torque x 100). A lower value represents a better outcome. Scale range is \~15 - 35% for most healthy populations.
Outcome measures
| Measure |
Berry Extract Intake
n=18 Participants
Intake of a berry extract supplement (hawthorn berry extract, tart cherry extract, and bromelain)
Berry extract: Berry extract supplement (hawthorn berry extract, tart cherry extract, bromelain)
|
Placebo Intake
n=18 Participants
Intake of a placebo (flour capsule)
Placebo: Placebo (flour capsule)
|
|---|---|---|
|
Exercise Fatigue Index During Leg Flexion
|
24.9 percent fatigue
Standard Deviation 11.2
|
24.8 percent fatigue
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: 1 dayTotal antioxidant capacity assessed from the venous blood (plasma). A higher value represents a better outcome. Scale range is 10 - 20 millimoles per milliliter for most healthy populations.
Outcome measures
| Measure |
Berry Extract Intake
n=18 Participants
Intake of a berry extract supplement (hawthorn berry extract, tart cherry extract, and bromelain)
Berry extract: Berry extract supplement (hawthorn berry extract, tart cherry extract, bromelain)
|
Placebo Intake
n=18 Participants
Intake of a placebo (flour capsule)
Placebo: Placebo (flour capsule)
|
|---|---|---|
|
Plasma Total Antioxidant Capacity
|
15.8 millimoles per milliliter
Standard Deviation 9.0
|
15.0 millimoles per milliliter
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: 1 dayOxygenated hemoglobin was measured in arbitrary units (a.u.). Higher values represent a better outcome. Scale range for oxygenated hemoglobin is \~5-15 a.u. in healthy populations
Outcome measures
| Measure |
Berry Extract Intake
n=18 Participants
Intake of a berry extract supplement (hawthorn berry extract, tart cherry extract, and bromelain)
Berry extract: Berry extract supplement (hawthorn berry extract, tart cherry extract, bromelain)
|
Placebo Intake
n=18 Participants
Intake of a placebo (flour capsule)
Placebo: Placebo (flour capsule)
|
|---|---|---|
|
Oxygenated Hemoglobin
|
10.1 arbitrary units (a.u.)
Standard Deviation 7.1
|
9.6 arbitrary units (a.u.)
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: 1 dayDeoxygenated hemoglobin was measured in arbitrary units (a.u.). Lower values represent a better outcome. Scale range for deoxygenated hemoglobin is \~ - 5-5 in healthy populations
Outcome measures
| Measure |
Berry Extract Intake
n=18 Participants
Intake of a berry extract supplement (hawthorn berry extract, tart cherry extract, and bromelain)
Berry extract: Berry extract supplement (hawthorn berry extract, tart cherry extract, bromelain)
|
Placebo Intake
n=18 Participants
Intake of a placebo (flour capsule)
Placebo: Placebo (flour capsule)
|
|---|---|---|
|
Deoxygenated Hemoglobin
|
-0.4 arbitrary units (a.u.)
Standard Deviation 1.3
|
-2.7 arbitrary units (a.u.)
Standard Deviation 8.7
|
Adverse Events
Berry Extract Intake
Placebo Intake
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place