HealthyBAMNCT04175106
Evaluating the Availability of Berry Phytonutrients Post-consumption of Fresh and Processed Blueberry by Healthy Adults
A study testing 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, a standard commercially available blueberry variety (i.e., cultivar) and a "minimally processed" blueberry-rich protein bar in people with Healthy, run by North Carolina State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 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, a standard commercially available blueberry variety (i.e., cultivar) and a "minimally processed" blueberry-rich protein bar
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2019to 29 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Plants for Human Health Institute, North Carolina State University
Kannapolis, North Carolina, 28081
About this study
Official title: Establishing Optimal Nutritional Quality of Blueberries: a Proof of Concept Study to Improve the Nutritional Quality of the Average Diet Using Common Plant Breeding and Processing Practices.
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).
- Conditions
- Healthy
- Being tested
- 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, a standard commercially available blueberry variety (i.e., cultivar), a "minimally processed" blueberry-rich protein bar, a control beverage of matched-nutritive content
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 valueOther
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.
a standard commercially available blueberry variety (i.e., cultivar)Other
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.
a "minimally processed" blueberry-rich protein barOther
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.
a control beverage of matched-nutritive contentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| a phytochemical-rich blueberry variety | Experimental | Single-time consumption of 150 g phytochemical-rich blueberry per participant. Receives: 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 |
| a phytochemical-poor blueberry variety | Experimental | Single-time consumption of 150 g phytochemical-poor blueberry per participant. Receives: Other: a standard commercially available blueberry variety (i.e., cultivar) |
| a "minimally processed" blueberry-rich protein bar | Experimental | Single-time consumption of blueberry-rich protein bar matched for 150 g blueberry phytochemicals. Receives: Other: a "minimally processed" blueberry-rich protein bar |
| a blueberry control beverage of matched-nutritive content | Placebo comparator | Single-time consumption of control beverage matched for the macronutrient content of the blueberry-rich protein bar. Receives: Other: a control beverage of matched-nutritive content |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 days of urine collection per intervention; -48, -24, 0-9, 9-24 and 24-48 hours collections of urine.
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start13 Dec 2019
- Primary completion29 Oct 2021
- Study completion29 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Carolina State University
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Food and Agriculture Research
- Responsible party
- Principal investigator, Colin D. Kay, North Carolina State University
- Investigators
- Colin D Kay, PhD, Principal investigator, North Carolina State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175106
- Sponsor's protocol ID
- 19138
- Acronym
- BAM
- Status last verified
- Feb 2026
- First submitted
- 13 Nov 2019
- Last updated
- 9 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Optimal Nutritional Quality of Blueberries: a Proof of Concept Study to Improve the Nutritional Quality of the Average Diet Using Common Plant Breeding and Processing Practices.
- ClinicalTrials.gov ID
- NCT04175106
- Acronym / sponsor ID
- BAM / 19138
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- North Carolina State UniversityUniversity, hospital or other
- Collaborators
- Foundation for Food and Agriculture Research
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 22 Nov 2019 (actual)
- Results
- Posted 9 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| a phytochemical-rich blueberry variety | Experimental | 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 valueSingle-time consumption of 150 g phytochemical-rich blueberry per participant. |
| a phytochemical-poor blueberry variety | Experimental | Other: a standard commercially available blueberry variety (i.e., cultivar)Single-time consumption of 150 g phytochemical-poor blueberry per participant. |
| a "minimally processed" blueberry-rich protein bar | Experimental | Other: a "minimally processed" blueberry-rich protein barSingle-time consumption of blueberry-rich protein bar matched for 150 g blueberry phytochemicals. |
| a blueberry control beverage of matched-nutritive content | Placebo comparator | Other: a control beverage of matched-nutritive contentSingle-time consumption of control beverage matched for the macronutrient content of the blueberry-rich protein bar. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 value150 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. | Other | a phytochemical-rich blueberry variety |
| a 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. | Other | a phytochemical-poor blueberry variety |
| a "minimally processed" blueberry-rich protein barA "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. | Other | a "minimally processed" blueberry-rich protein bar |
| a control beverage of matched-nutritive contentThe 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. | Other | a blueberry control beverage of matched-nutritive content |
Primary outcome
Total Urinary Recovery of (Poly)Phenolic Metabolites Across Treatments
Time frame: 4 days of urine collection per intervention; -48, -24, 0-9, 9-24 and 24-48 hours collections of urine.
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.
Serum Area Under the Curve (AUC) of (Poly)Phenolic Metabolites Across Treatments
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.
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.
1 secondary outcome
Maximum Serum Concentration [Cmax] of (Poly)Phenolic Metabolites Between the Treatments
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 39894303Santana 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.
- Publication of Clinical Study ResultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colin D Kay, PhD principal investigator
North Carolina State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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, a standard commercially available blueberry variety (i.e., cultivar) and a "minimally processed" blueberry-rich protein bar in people with Healthy, run by North Carolina State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Urinary Recovery of (Poly)Phenolic Metabolites Across Treatments (time frame: 4 days of urine collection per intervention; -48, -24, 0-9, 9-24 and 24-48 hours collections of urine.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04175106, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.