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CompletedNCT04175106BAMUpdated Feb 9, 2026Results posted

Evaluating the Availability of Berry Phytonutrients Post-consumption of Fresh and Processed Blueberry by Healthy Adults

An interventional study of a non-traditional (i.e., not typically available in the supermarket) blueberry cultivar bred using natural plant breeding techniques and established as having enhanced nutritive value and a standard commercially available blueberry variety (i.e., cultivar) in Healthy, sponsored by North Carolina State University. Completed at 1 site in United States. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-09.

Sponsored by North Carolina State University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Study summary

This study will evaluate the availability of phytonutrients in two blueberry varieties, chosen for their phytonutrient levels. This will be compared to phytonutrient-matched processed protein bar and a macronutrient-matched control meal, in healthy human volunteers. Blueberry phytonutrients will be analyzed in blood and urine over a four-day period, 48h prior to consumption and 48h after. The participants will consume each of the four meals over a 3-month period (4-way crossover design, 4 blocks of 4-day periods). The main objective of this study is to compare the proportions of blueberry phytonutrients recovered in the blood and urine after ingestion of the four treatments. We hypothesize that phytonutrient content will be predictive of human bioavailability and that a berry-enriched processed product will have similar phytonutrient bioavailability to unprocessed berries.

The results of this study may establish if the nutritional value of a berry can be predicted or enhanced to provide elevated nutritional quality, with the ultimate goal of maximizing the health benefits of fruit consumption. As it is challenging for many to increase their fruit and vegetable intake to government recommended levels (5+ servings per day), the present proof-of-concept study explores a reasonable approach to help consumers achieve optimal health associated with high fruit and vegetable intakes, within the context of current consumption patterns, through enhancement of the nutritional density and bioavailability of common fruits and consumer products.

Read the detailed description

This study will evaluate the availability of phytonutrients in two blueberry varieties, chosen for their phytonutrient levels. This will be compared to phytonutrient-matched processed protein bar and a macronutrient-matched control meal, in healthy human volunteers. Blueberry phytonutrients will be analyzed in blood and urine over a four-day period, 48h prior to consumption and 48h after. The participants will consume each of the four meals over a 3-month period (4-way crossover design, 4 blocks of 4-day periods).

The main objective of this study is to compare the proportions of blueberry phytonutrients recovered in the blood and urine after ingestion of the four treatments.

After eligibility is confirmed, subjects will be randomly assigned to the four berry related interventions. The consumption of each intervention corresponds to one study period, which are separated by one-week washout. Blood will be collected at baseline and across 48h (1h, 3h, 6h, 9h, 24h, 48h) after intervention consumption while urine will be collected for 48h before and after intervention (-48h, -24h, 0-9h, 9-24h, 24-48h).

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

North Carolina State University is the lead sponsor of 26 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • male and female adults between 25-65 years;
  • non-smokers, non-tobacco users (no vaping nor deeping), or who ceased it ≥ 6 months ago;
  • who present no allergies to fruits or vegetables containing polyphenolic (e.g. anthocyanins, flavonoids) and phenolic acids such as blueberries, red apple, strawberry, red orange, purple onion and broccoli;
  • who present no allergies to dairy products, specifically whey protein, fructose or salicylates;
  • who are generally healthy and without chronic diseases including cancer, type 1 and 2 diabetes;
  • who are not prescribed thyroid or hypoglycemic medication or hormone replacement therapy (HRT) (due to the likely concomitant effects that these medications cause on the primary endpoint in the trial);
  • who has not been consuming any phytonutrient-containing supplements (e.g. with cocoa, coffee, berry, polyphenol, flavonoid, or anthocyanin extracts) for at least a month before the study and willing to not consume it during the study;
  • who lives within 40 miles from the North Carolina Research Campus (NCRC) campus;
  • those agreeing to restrict dietary intake of rich sources of phytonutrients targeted on the study during the wash-out and clinical sampling periods, agreeing to comply with a biological sampling protocol involving the collection of urine and blood samples, and to record their additional dietary intake over 2 days before each intervention, and two days after the intake of the intervention treatments;
  • who have BMI ≥18.5 and ≤ 30 (lbs/in2x703);
  • who have a successful (i.e., within normal range for healthy individuals) biochemical, hematological and urine analyses assessed by the clinical advisor as established during the screening period prior to final enrollment.

Exclusion criteria

Exclusion Criteria:

  • current smokers (vaping and deeping included), or ex-smokers ceasing \< 6 months before recruitment;
  • pregnant or breastfeeding;
  • subjects with existing or significant past medical history of vascular disease or medical conditions likely to affect the study measures i.e. vascular disease, circulatory (i.e. Reynaud's), diabetes, hepatic, renal, digestive, hematological, cancer, or thyroid disease;
  • fructose intolerant subjects or those with known allergy to salicylates, dairy products, specifically whey protein, or to berries;
  • those unprepared to adhere to dietary restrictions for 1 week preceding and during each intervention or unwilling to comply with the assessments per protocol;
  • who are in parallel participation in another research project involving dietary intervention and/or sampling of biological fluids/material;
  • those on therapeutic diets or having experienced substantial weight loss (to be judged by clinical advisor) within 3 months of screening;
  • those taking phytonutrient-containing supplements (e.g. with cocoa, coffee, berry, polyphenol, flavonoid, or anthocyanin extracts), unwilling to cease intake during, and 1 month preceding the trial, or unwilling to stop existing intake of other supplements or regular use of large-dose nutrient, herbal, and dietary supplements during the past one to two weeks, or planning to use them during the study;
  • prescribed thyroid, hypoglycemic medication or HRT medication -other medications will be assessed for suitability by the clinical advisor;
  • those having donated blood in the last month;
  • individuals that consume more than 1 and 2 drinks of alcohol per day for women and men, respectively, or more than 7 and 14 drinks per week for women and men, respectively (U.S. Department of Health and Human Services and U.S. Department of Agriculture Dietary guidelines 2015-2020);
  • currently on a weight-reducing plan or using weight-loss medications (e.g., selective serotonin reuptake inhibitors, steroids, Ritalin, appetite suppressants such as Diethylpropion or Amfepramone, and weight loss medications such as Alli, Xenical, Qsymia, Belviq, Contrave, and Saxenda), or planning to continue this treatment during the 10-week period of the study;
  • who has BMI\<18.5 and >30 (lbs/in2x703);
  • who presents abnormal biochemical, hematological or urinary results, and measurements considered to be counter-indicative for the study, including: kidney and liver function, fasting glucose (especially if indicative of diabetes), lipid abnormalities, full blood count as established during the screening period prior to final enrollment.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    a phytochemical-rich blueberry variety

    Single-time consumption of 150 g phytochemical-rich blueberry per participant.

    Other: a non-traditional (i.e., not typically available in the supermarket) blueberry cultivar bred using natural plant breeding techniques and established as having enhanced nutritive value

  • Experimental
    a phytochemical-poor blueberry variety

    Single-time consumption of 150 g phytochemical-poor blueberry per participant.

    Other: a standard commercially available blueberry variety (i.e., cultivar)

  • Experimental
    a "minimally processed" blueberry-rich protein bar

    Single-time consumption of blueberry-rich protein bar matched for 150 g blueberry phytochemicals.

    Other: a "minimally processed" blueberry-rich protein bar

  • Placebo comparator
    a blueberry control beverage of matched-nutritive content

    Single-time consumption of control beverage matched for the macronutrient content of the blueberry-rich protein bar.

    Other: a control beverage of matched-nutritive content

Interventions

  • Othera non-traditional (i.e., not typically available in the supermarket) blueberry cultivar bred using natural plant breeding techniques and established as having enhanced nutritive value

    150 g of a non-traditional (i.e., not typically available in the supermarket) blueberry cultivar bred using natural plant breeding techniques and established as having enhanced nutritive value. Dietary restrictions will be observed (i.e. avoidance of food or supplements containing berry phytonutrients) for 7 days before each arm visit and throughout the study days.

  • Othera standard commercially available blueberry variety (i.e., cultivar)

    150 g of a standard commercially available blueberry variety (i.e., cultivar). Dietary restrictions will be observed (i.e. avoidance of food or supplements containing berry phytonutrients) for 7 days before each arm visit and throughout the study days.

  • Othera "minimally processed" blueberry-rich protein bar

    A "minimally processed" blueberry-rich protein bar matched to the phytonutrient content of the 150 g of the non-traditional blueberry. Dietary restrictions will be observed (i.e. avoidance of food or supplements containing berry phytonutrients) for 7 days before each arm visit and throughout the study days.

  • Othera control beverage of matched-nutritive content

    The matched nutritive content of the blueberry-rich protein bar will be dissolved in whey protein Dietary restrictions will be observed (i.e. avoidance of food or supplements containing berry phytonutrients) for 7 days before each arm visit and throughout the study days.

06

What researchers measure

Primary outcomes

  1. Total Urinary Recovery of (Poly)Phenolic Metabolites Across Treatments

    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.

    Time frame: 4 days of urine collection per intervention; -48, -24, 0-9, 9-24 and 24-48 hours collections of urine.

  2. Serum Area Under the Curve (AUC) of (Poly)Phenolic Metabolites Across Treatments

    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.

    Time frame: 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.

Secondary outcomes

  1. Maximum Serum Concentration [Cmax] of (Poly)Phenolic Metabolites Between the Treatments

    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.

    Time frame: 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.

Other outcomes

  1. Time at Maximum Concentration [Tmax] of (Poly)Phenolic Metabolites in Serum Between the Treatments

    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.

    Time frame: 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.

07

Results

Posted Feb 9, 2026
Limitations and caveats
Some limitations in this study include the lack of a software to evaluate background diet, and lack of measurement of composition of the protein bars. Further, compliance to a diet low in (poly)phenols (but not polyphenol-free) was evaluated through food intake logs and a strictly controlled and (poly)phenol-free diet is only feasible in a metabolic ward/domicile study design, which is relatively rare for (poly)phenol interventions. Also, we cannot account for nonreported noncompliance events.

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.

Participant flow — Overall Study
MilestonePhytochemical-rich and -Poor Blueberry Varieties, Blueberry-rich Protein Bar and a Control Beverage
Started29
Phytochemical-rich blueberry variety18
Phytochemical-poor blueberry variety23
"minimally processed" blueberry-rich protein bar22
Blueberry control beverage of matched-nutritive content23
Completed18
Not completed11
Withdrew: Discontinued intervention (covid-19)2
Withdrew: Non-compliance3
Withdrew: Lost to follow-up1
Withdrew: Lack of availability3
Withdrew: Discomfort2

Outcome measures

PrimaryTotal Urinary Recovery of (Poly)Phenolic Metabolites Across Treatments

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.

Time frame:
4 days of urine collection per intervention; -48, -24, 0-9, 9-24 and 24-48 hours collections of urine.
Reported as:
Number · mg
Total Urinary Recovery of (Poly)Phenolic Metabolites Across Treatments
mgPhytochemical-rich Blueberry Variety (Elliott Blueberry Variety)Phytochemical-poor Blueberry Variety (Olympia Blueberry Variety)"Minimally Processed" Blueberry-rich Protein BarControl Beverage of Matched-nutritive Content
Total Urinary Recovery of (Poly)Phenolic Metabolites Across Treatments179.50142.41127.7883.15
Statistical analysis
  • Phytochemical-rich Blueberry Variety (Elliott Blueberry Variety) vs Phytochemical-poor Blueberry Variety (Olympia Blueberry Variety) vs "Minimally Processed" Blueberry-rich Protein Bar vs Control Beverage of Matched-nutritive Content · ANOVA · p = <0.05 (Concentration data was assessed for normalization using the Shapiro-Wilk test and normalized using log(1+x) when deemed non-normalized.)Changes across groups via linear mixed-effects repeated measures ANOVA, and post-hoc analysis (Bonferroni test and Kenward-Roger degrees of freedom).
PrimarySerum Area Under the Curve (AUC) of (Poly)Phenolic Metabolites Across Treatments

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.

Time frame:
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.
Reported as:
Number · ng*h/mL
Serum Area Under the Curve (AUC) of (Poly)Phenolic Metabolites Across Treatments
ng*h/mLPhytochemical-rich Blueberry Variety (Elliott Blueberry Variety)Phytochemical-poor Blueberry Variety (Olympia Blueberry Variety)"Minimally Processed" Blueberry-rich Protein BarControl Beverage of Matched-nutritive Content
Serum Area Under the Curve (AUC) of (Poly)Phenolic Metabolites Across Treatments3889.343049.403515.232704.96
Statistical analysis
  • Phytochemical-rich Blueberry Variety (Elliott Blueberry Variety) vs Phytochemical-poor Blueberry Variety (Olympia Blueberry Variety) vs "Minimally Processed" Blueberry-rich Protein Bar vs Control Beverage of Matched-nutritive Content · ANOVA · p = <0.05 (Concentration data was assessed for normalization using the Shapiro-Wilk test and normalized using log(1+x) when deemed non-normalized.)Changes across groups via linear mixed-effects repeated measures ANOVA, and post-hoc analysis (Bonferroni test and Kenward-Roger degrees of freedom).
SecondaryMaximum Serum Concentration [Cmax] of (Poly)Phenolic Metabolites Between the Treatments

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.

Time frame:
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.
Reported as:
Mean · ng/mL
Maximum Serum Concentration [Cmax] of (Poly)Phenolic Metabolites Between the Treatments
ng/mLPhytochemical-rich Blueberry Variety (Elliott Blueberry Variety)Phytochemical-poor Blueberry Variety (Olympia Blueberry Variety)"Minimally Processed" Blueberry-rich Protein BarControl Beverage of Matched-nutritive Content
Maximum Serum Concentration [Cmax] of (Poly)Phenolic Metabolites Between the Treatments15.37 (0.43 to 63.75)8.44 (0.36 to 25.82)11.15 (0.37 to 28.17)6.96 (0.21 to 32.34)
Statistical analysis
  • Phytochemical-rich Blueberry Variety (Elliott Blueberry Variety) vs Phytochemical-poor Blueberry Variety (Olympia Blueberry Variety) vs "Minimally Processed" Blueberry-rich Protein Bar vs Control Beverage of Matched-nutritive Content · ANOVA · p = <0.05 (Concentration data was assessed for normalization using the Shapiro-Wilk test and normalized using log(1+x) when deemed non-normalized.)Changes across groups via linear mixed-effects repeated measures ANOVA, and post-hoc analysis (Bonferroni test and Kenward-Roger degrees of freedom).
Other pre-specifiedTime at Maximum Concentration [Tmax] of (Poly)Phenolic Metabolites in Serum Between the Treatments

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.

Time frame:
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.
Reported as:
Mean · hour
Time at Maximum Concentration [Tmax] of (Poly)Phenolic Metabolites in Serum Between the Treatments
hourPhytochemical-rich Blueberry Variety (Elliott Blueberry Variety)Phytochemical-poor Blueberry Variety (Olympia Blueberry Variety)"Minimally Processed" Blueberry-rich Protein BarControl Beverage of Matched-nutritive Content
Time at Maximum Concentration [Tmax] of (Poly)Phenolic Metabolites in Serum Between the Treatments6.35 (3.65 to 10.34)6.96 (2.91 to 12.35)7.70 (2.48 to 16.66)9.96 (1.33 to 19.83)
Statistical analysis
  • Phytochemical-rich Blueberry Variety (Elliott Blueberry Variety) vs Phytochemical-poor Blueberry Variety (Olympia Blueberry Variety) vs "Minimally Processed" Blueberry-rich Protein Bar vs Control Beverage of Matched-nutritive Content · ANOVA · p = <0.05 (Concentration data was assessed for normalization using the Shapiro-Wilk test and normalized using log(1+x) when deemed non-normalized.)Changes across groups via linear mixed-effects repeated measures ANOVA, and post-hoc analysis (Bonferroni test and Kenward-Roger degrees of freedom).

Adverse events

Collected over From participant enrollment to study completion (3.9 ± 1.7-mo period).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
a Phytochemical-rich Blueberry Variety (Elliott Blueberry Variety)0/18 (0%)0/18 (0%)0/18 (0%)
a Phytochemical-poor Blueberry Variety (Olympia Blueberry Variety)0/18 (0%)0/18 (0%)0/18 (0%)
a "Minimally Processed" Blueberry-rich Protein Bar0/18 (0%)0/18 (0%)0/18 (0%)
a Blueberry Control Beverage of Matched-nutritive Content0/18 (0%)0/18 (0%)0/18 (0%)

Baseline characteristics

Baseline data shown from baseline visits of participants who completed participation in the study across all four arms/groups (i.e., 18 participants).

Age, Continuous
Age, Continuous(years)Phytochemical-rich and -Poor Blueberry Varieties, Blueberry-rich Protein Bar and a Control Beverage
Mean42.06 ± 12.53
Sex: Female, Male
Sex: Female, Male(Participants)Phytochemical-rich and -Poor Blueberry Varieties, Blueberry-rich Protein Bar and a Control Beverage
Female11
Male7
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Phytochemical-rich and -Poor Blueberry Varieties, Blueberry-rich Protein Bar and a Control Beverage
Region of Enrollment
Region of Enrollment(participants)Phytochemical-rich and -Poor Blueberry Varieties, Blueberry-rich Protein Bar and a Control Beverage
United States18
Systolic Blood pressure, mmHg
Systolic Blood pressure, mmHg(mmHg)Phytochemical-rich and -Poor Blueberry Varieties, Blueberry-rich Protein Bar and a Control Beverage
Mean116.12 ± 13.00
Diastolic Blood pressure, mmHg
Diastolic Blood pressure, mmHg(mmHg)Phytochemical-rich and -Poor Blueberry Varieties, Blueberry-rich Protein Bar and a Control Beverage
Mean71.54 ± 7.63
BMI, kg/m2
BMI, kg/m2(kg/m2)Phytochemical-rich and -Poor Blueberry Varieties, Blueberry-rich Protein Bar and a Control Beverage
Mean24.75 ± 2.99
Weight (kg)
Weight (kg)(kg)Phytochemical-rich and -Poor Blueberry Varieties, Blueberry-rich Protein Bar and a Control Beverage
Mean73.8 ± 13.72

1 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Plants for Human Health Institute, North Carolina State University
    Kannapolis, North Carolina 28081, United States
09

References and documents

Publications

  • Santana MC, Rathore AS, Chandra P, Everhart JL, Schulz H, Granillo CD, Ferruzzi MG, Iorizzo M, Lila MA, Diaz JT, Kay CD. Bioavailability and pharmacokinetics of (poly)phenols following consumption of selected blueberries and a blueberry-rich protein bar by adult males and females: a randomized, crossover, controlled trial. Am J Clin Nutr. 2025 Apr;121(4):779-794. doi: 10.1016/j.ajcnut.2025.01.028. Epub 2025 Jan 31. PubMed 39894303 ↗

Study documents

  • Study protocol · Nov 19, 2020
  • Statistical analysis plan · Oct 25, 2020
  • Informed consent form · Jun 1, 2020
  • Informed consent form · Aug 4, 2020

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04175106
Lead sponsor
North Carolina State University
Collaborators
Foundation for Food and Agriculture Research
Responsible party
Colin D. Kay (Associate Professor in Nutrition Science, PhD, North Carolina State University) — Principal investigator
First posted
Nov 22, 2019
Start date
Dec 13, 2019
Primary completion
Oct 29, 2021
Completion
Oct 29, 2021
Results posted
Feb 9, 2026
Last update
Feb 9, 2026

Study contacts

Colin D Kay, PhD
principal investigator · North Carolina State University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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