Trial Outcomes & Findings for Evaluating the Availability of Berry Phytonutrients Post-consumption of Fresh and Processed Blueberry by Healthy Adults (NCT NCT04175106)
NCT ID: NCT04175106
Last Updated: 2026-02-09
Results Overview
Concentration of 185 (poly)phenolic metabolites in urine was measured after consumption of the treatments using broad spectrum metabolomic analysis via UPLC-MS/MS (ultra-performance liquid chromatography coupled with tandem mass spectrometry). Recovery of each metabolite was calculated by multiplying the concentration of the metabolite (ng/mL) by the volume of urine (mL) in each collection then converted to milligrams. The total urinary recovery of each (poly)phenolic metabolite was assessed as a measurement of their bioavailability, and it was established as the sum of the recovery from each urine collection (0 h to 48 h postintervention) minus the mean of the 48 h and 24 h baseline collections per participant and treatment. Then, it was averaged across participants per treatment and per metabolite, and further summed across metabolites. Therefore, data reported for each treatment represents the sum of the means of total urinary recovery across (poly)phenolic metabolites.
COMPLETED
NA
29 participants
4 days of urine collection per intervention; -48, -24, 0-9, 9-24 and 24-48 hours collections of urine.
2026-02-09
Participant Flow
75 participants were recruited and screened from the local community surrounding the North Carolina Research Campus, Kannapolis, North Carolina, between December 2019 and July 2021. Clinical screening and interventions were conducted at the Human Research Core at the Nutrition Research Institute (University of North Carolina-Chapel Hill). The trial was completed in October 2021.
29 out of 75 screened participants were enrolled into the study and randomized to interventions. Of those not enrolled, 20 participants did not meet inclusion criteria, 17 declined to participate and 9 did not follow up.
Participant milestones
| Measure |
Phytochemical-rich and -Poor Blueberry Varieties, Blueberry-rich Protein Bar and a Control Beverage
All enrolled study participants were assigned to 13 distinct randomized intervention sequences where they consumed the following interventions, one at a time, and separated by 30.0±40.6 d of compliance break then 1-week of washout period: 150 g of a Phytochemical-rich Blueberry Variety (Elliott Blueberry Variety), 150 g of a Phytochemical-poor Blueberry Variety (Olympia Blueberry Variety), a "Minimally Processed" Blueberry-rich Protein Bar matched to the phytonutrient content of the 150 g of Phytochemical-rich Blueberry Variety, and a Blueberry Control Beverage of Matched-nutritive Content in a randomized order.
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
Phytochemical-rich Blueberry Variety
|
18
|
|
Overall Study
Phytochemical-poor Blueberry Variety
|
23
|
|
Overall Study
"Minimally Processed" Blueberry-rich Protein Bar
|
22
|
|
Overall Study
Blueberry Control Beverage of Matched-nutritive Content
|
23
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Phytochemical-rich and -Poor Blueberry Varieties, Blueberry-rich Protein Bar and a Control Beverage
All enrolled study participants were assigned to 13 distinct randomized intervention sequences where they consumed the following interventions, one at a time, and separated by 30.0±40.6 d of compliance break then 1-week of washout period: 150 g of a Phytochemical-rich Blueberry Variety (Elliott Blueberry Variety), 150 g of a Phytochemical-poor Blueberry Variety (Olympia Blueberry Variety), a "Minimally Processed" Blueberry-rich Protein Bar matched to the phytonutrient content of the 150 g of Phytochemical-rich Blueberry Variety, and a Blueberry Control Beverage of Matched-nutritive Content in a randomized order.
|
|---|---|
|
Overall Study
Discontinued intervention (COVID-19)
|
2
|
|
Overall Study
Non-compliance
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Lack of Availability
|
3
|
|
Overall Study
Discomfort
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Phytochemical-rich and -Poor Blueberry Varieties, Blueberry-rich Protein Bar and a Control Beverage
n=18 Participants
All enrolled study participants were assigned to 13 distinct randomized intervention sequences where they consumed the following interventions, one at a time, and separated by 30.0±40.6 d of compliance break then 1-week of washout period: 150 g of a Phytochemical-rich Blueberry Variety (Elliott Blueberry Variety), 150 g of a Phytochemical-poor Blueberry Variety (Olympia Blueberry Variety), a "Minimally Processed" Blueberry-rich Protein Bar matched to the phytonutrient content of the 150 g of Phytochemical-rich Blueberry Variety, and a Blueberry Control Beverage of Matched-nutritive Content in a randomized order.
|
|---|---|
|
Age, Continuous
|
42.06 years
STANDARD_DEVIATION 12.53 • n=18 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=18 Participants
|
|
Systolic Blood pressure, mmHg
|
116.12 mmHg
STANDARD_DEVIATION 13.00 • n=18 Participants
|
|
Diastolic Blood pressure, mmHg
|
71.54 mmHg
STANDARD_DEVIATION 7.63 • n=18 Participants
|
|
BMI, kg/m2
|
24.75 kg/m2
STANDARD_DEVIATION 2.99 • n=18 Participants
|
|
Weight (kg)
|
73.8 kg
STANDARD_DEVIATION 13.72 • n=18 Participants
|
|
Height (m)
|
1.72 meter
STANDARD_DEVIATION 0.10 • n=18 Participants
|
PRIMARY outcome
Timeframe: 4 days of urine collection per intervention; -48, -24, 0-9, 9-24 and 24-48 hours collections of urine.Population: All participants who completed all study visits. This analysis was pre-specified to only report data for (poly)phenolic metabolites that displayed treatment effects (p \< 0.05) in cumulative urinary excretion (i.e., 22 (poly)phenolic metabolites). Sum of the means of total urinary recovery across metabolites is reported per treatment.
Concentration of 185 (poly)phenolic metabolites in urine was measured after consumption of the treatments using broad spectrum metabolomic analysis via UPLC-MS/MS (ultra-performance liquid chromatography coupled with tandem mass spectrometry). Recovery of each metabolite was calculated by multiplying the concentration of the metabolite (ng/mL) by the volume of urine (mL) in each collection then converted to milligrams. The total urinary recovery of each (poly)phenolic metabolite was assessed as a measurement of their bioavailability, and it was established as the sum of the recovery from each urine collection (0 h to 48 h postintervention) minus the mean of the 48 h and 24 h baseline collections per participant and treatment. Then, it was averaged across participants per treatment and per metabolite, and further summed across metabolites. Therefore, data reported for each treatment represents the sum of the means of total urinary recovery across (poly)phenolic metabolites.
Outcome measures
| Measure |
Phytochemical-rich Blueberry Variety (Elliott Blueberry Variety)
n=18 Participants
Single-time consumption of 150 g of a Phytochemical-rich Blueberry Variety (Elliott Blueberry Variety) in a randomized order, and separated by 30.0±40.6 d of compliance break then 1-week of washout period from other interventions.
|
Phytochemical-poor Blueberry Variety (Olympia Blueberry Variety)
n=18 Participants
Single-time consumption of 150 g of a Phytochemical-poor Blueberry Variety (Olympia Blueberry Variety) in a randomized order, and separated by 30.0±40.6 d of compliance break then 1-week of washout period from other interventions.
|
"Minimally Processed" Blueberry-rich Protein Bar
n=18 Participants
Single-time consumption of a "Minimally Processed" Blueberry-rich Protein Bar matched to the phytonutrient content of the 150 g of Phytochemical-rich Blueberry Variety in a randomized order and separated by 30.0±40.6 d of compliance break then 1-week of washout period from other interventions.
|
Control Beverage of Matched-nutritive Content
n=18 Participants
Single-time consumption of a control beverage matched for the macronutrient content of the blueberry-rich protein bar in a randomized order and separated by 30.0±40.6 d of compliance break then 1-week of washout period from other interventions.
|
|---|---|---|---|---|
|
Total Urinary Recovery of (Poly)Phenolic Metabolites Across Treatments
|
179.50 mg
|
142.41 mg
|
127.78 mg
|
83.15 mg
|
PRIMARY outcome
Timeframe: 3 days of blood collection per intervention; 1 baseline collection, followed by 1, 3, 6, 9, 24 and 48 hours post-treatment collections of blood.Population: All participants who completed all study visits. This analysis was pre-specified to only report data for (poly)phenolic metabolites that displayed treatment-by-time, treatment, and time effects (p \< 0.05) in serum concentration (i.e., 20 (poly)phenolic metabolites). Sum of the means of AUC across metabolites is reported per treatment.
Concentration of 185 (poly)phenolic metabolites in blood was measured after consumption of the treatments using broad spectrum metabolomic analysis via UPLC-MS/MS (ultra-performance liquid chromatography coupled with tandem mass spectrometry). The area under the curve (AUC) of each (poly)phenolic metabolite in serum was assessed as a measurement of the bioavailability of these metabolites per participant and treatment. It was calculated using concentration and time data in the software Phoenix WinNonlin (version 8.3, Certara). Then, AUC was averaged across participants per treatment and per metabolite, and the mean AUCs were further summed across metabolites. Therefore, data reported for each treatment represents the sum of the means of AUC across (poly)phenolic metabolites.
Outcome measures
| Measure |
Phytochemical-rich Blueberry Variety (Elliott Blueberry Variety)
n=18 Participants
Single-time consumption of 150 g of a Phytochemical-rich Blueberry Variety (Elliott Blueberry Variety) in a randomized order, and separated by 30.0±40.6 d of compliance break then 1-week of washout period from other interventions.
|
Phytochemical-poor Blueberry Variety (Olympia Blueberry Variety)
n=18 Participants
Single-time consumption of 150 g of a Phytochemical-poor Blueberry Variety (Olympia Blueberry Variety) in a randomized order, and separated by 30.0±40.6 d of compliance break then 1-week of washout period from other interventions.
|
"Minimally Processed" Blueberry-rich Protein Bar
n=18 Participants
Single-time consumption of a "Minimally Processed" Blueberry-rich Protein Bar matched to the phytonutrient content of the 150 g of Phytochemical-rich Blueberry Variety in a randomized order and separated by 30.0±40.6 d of compliance break then 1-week of washout period from other interventions.
|
Control Beverage of Matched-nutritive Content
n=18 Participants
Single-time consumption of a control beverage matched for the macronutrient content of the blueberry-rich protein bar in a randomized order and separated by 30.0±40.6 d of compliance break then 1-week of washout period from other interventions.
|
|---|---|---|---|---|
|
Serum Area Under the Curve (AUC) of (Poly)Phenolic Metabolites Across Treatments
|
3889.34 ng*h/mL
|
3049.40 ng*h/mL
|
3515.23 ng*h/mL
|
2704.96 ng*h/mL
|
SECONDARY outcome
Timeframe: 3 days of blood collection per intervention; 1 baseline collection, followed by 1, 3, 6, 9, 24 and 48 hours post-treatment collections of blood.Population: All participants who completed all study visits. This analysis was pre-specified to only report data for (poly)phenolic metabolites that displayed treatment-by-time, treatment, and time effects (p \< 0.05) in serum concentration (i.e., 20 (poly)phenolic metabolites). Mean of the means of Cmax across metabolites is reported per treatment.
Concentration of 185 (poly)phenolic metabolites in serum was measured after consumption of the treatments using broad spectrum metabolomic analysis via UPLC-MS/MS (ultra-performance liquid chromatography coupled with tandem mass spectrometry). The maximum serum concentration \[Cmax\] of each (poly)phenolic metabolite in serum was calculated per participant and treatment using concentration and time data in the software Phoenix WinNonlin (version 8.3, Certara). Then, it was averaged across participants per treatment and per metabolite, and further averaged across metabolites. Therefore, data reported for each treatment represents the mean of the means of Cmax across (poly)phenolic metabolites.
Outcome measures
| Measure |
Phytochemical-rich Blueberry Variety (Elliott Blueberry Variety)
n=18 Participants
Single-time consumption of 150 g of a Phytochemical-rich Blueberry Variety (Elliott Blueberry Variety) in a randomized order, and separated by 30.0±40.6 d of compliance break then 1-week of washout period from other interventions.
|
Phytochemical-poor Blueberry Variety (Olympia Blueberry Variety)
n=18 Participants
Single-time consumption of 150 g of a Phytochemical-poor Blueberry Variety (Olympia Blueberry Variety) in a randomized order, and separated by 30.0±40.6 d of compliance break then 1-week of washout period from other interventions.
|
"Minimally Processed" Blueberry-rich Protein Bar
n=18 Participants
Single-time consumption of a "Minimally Processed" Blueberry-rich Protein Bar matched to the phytonutrient content of the 150 g of Phytochemical-rich Blueberry Variety in a randomized order and separated by 30.0±40.6 d of compliance break then 1-week of washout period from other interventions.
|
Control Beverage of Matched-nutritive Content
n=18 Participants
Single-time consumption of a control beverage matched for the macronutrient content of the blueberry-rich protein bar in a randomized order and separated by 30.0±40.6 d of compliance break then 1-week of washout period from other interventions.
|
|---|---|---|---|---|
|
Maximum Serum Concentration [Cmax] of (Poly)Phenolic Metabolites Between the Treatments
|
15.37 ng/mL
Interval 0.43 to 63.75
|
8.44 ng/mL
Interval 0.36 to 25.82
|
11.15 ng/mL
Interval 0.37 to 28.17
|
6.96 ng/mL
Interval 0.21 to 32.34
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 days of blood collection per intervention; 1 baseline collection, followed by 1, 3, 6, 9, 24 and 48 hours post-treatment collections of blood.Population: All participants who completed all study visits. This analysis was pre-specified to only report data for (poly)phenolic metabolites that displayed treatment-by-time, treatment, and time effects (p \< 0.05) in serum concentration (i.e., 20 (poly)phenolic metabolites). Mean of the means of Tmax across metabolites is reported per treatment.
Concentration of 185 (poly)phenolic metabolites in serum was measured after consumption of the treatments using broad spectrum metabolomic analysis via UPLC-MS/MS (ultra-performance liquid chromatography coupled with tandem mass spectrometry). The time at maximum serum concentration \[Tmax\] of each (poly)phenolic metabolite in serum was calculated per participant and treatment using concentration and time data in the software Phoenix WinNonlin (version 8.3, Certara). Then, it was averaged across participants per treatment and per metabolite, and further averaged across metabolites. Data reported for each treatment represents the mean of the means of Tmax across (poly)phenolic metabolites.
Outcome measures
| Measure |
Phytochemical-rich Blueberry Variety (Elliott Blueberry Variety)
n=18 Participants
Single-time consumption of 150 g of a Phytochemical-rich Blueberry Variety (Elliott Blueberry Variety) in a randomized order, and separated by 30.0±40.6 d of compliance break then 1-week of washout period from other interventions.
|
Phytochemical-poor Blueberry Variety (Olympia Blueberry Variety)
n=18 Participants
Single-time consumption of 150 g of a Phytochemical-poor Blueberry Variety (Olympia Blueberry Variety) in a randomized order, and separated by 30.0±40.6 d of compliance break then 1-week of washout period from other interventions.
|
"Minimally Processed" Blueberry-rich Protein Bar
n=18 Participants
Single-time consumption of a "Minimally Processed" Blueberry-rich Protein Bar matched to the phytonutrient content of the 150 g of Phytochemical-rich Blueberry Variety in a randomized order and separated by 30.0±40.6 d of compliance break then 1-week of washout period from other interventions.
|
Control Beverage of Matched-nutritive Content
n=18 Participants
Single-time consumption of a control beverage matched for the macronutrient content of the blueberry-rich protein bar in a randomized order and separated by 30.0±40.6 d of compliance break then 1-week of washout period from other interventions.
|
|---|---|---|---|---|
|
Time at Maximum Concentration [Tmax] of (Poly)Phenolic Metabolites in Serum Between the Treatments
|
6.35 hour
Interval 3.65 to 10.34
|
6.96 hour
Interval 2.91 to 12.35
|
7.70 hour
Interval 2.48 to 16.66
|
9.96 hour
Interval 1.33 to 19.83
|
Adverse Events
a Phytochemical-rich Blueberry Variety (Elliott Blueberry Variety)
a Phytochemical-poor Blueberry Variety (Olympia Blueberry Variety)
a "Minimally Processed" Blueberry-rich Protein Bar
a Blueberry Control Beverage of Matched-nutritive Content
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Colin Kay
University of Arkansas for Medical Sciences at Arkansas Children's Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place