HealthyNCT04421950
The Blueberry Study
A study testing Wild blueberry containing foods in people with Healthy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
This is a research study about the effects of blueberries on the health of children who do not eat much fruits and vegetables. By doing this study, we hope to find out what nutrients from blueberries appear in the blood and urine of the child Read more about this study
- Who is it for?
- Ages 11 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Wild blueberry containing foods
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2021to 18 Aug 2022
- 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 11 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Eats <1.5 cup of fruit and <2.0 cup of vegetables per day
- Boys or girls
- All ethnicities
- All BMIs
Who cannot join
- Known allergy to blueberries
- Epilepsy
- Asthma
- Chronic kidney disease
- Hormonal disease
- Autoimmune disease
Show all 16Show fewer
- Bleeding disorders
- Chronic infections
- Type 2 and Type 1 diabetes mellitus
- Attention deficit hyperactivity disorder
- Opposition defiant disorder
- Autistic spectrum disorder
- Pre-existing medical conditions or medications as determined by the investigators to affect the outcomes of interest
- If the participants/parents perceive barriers with adhering to low-polyphenol meals
- Parent or child refusal to stop nutritional supplements
- Parent or child refusal to have blood drawn
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202
About this study
Official title: Plasma and Urine Profiles of Blueberry Derived Polyphenols After a Short Term Intervention With Blueberry in Children With Typical Low Fruit and Vegetable Consumption.
This is a research study about the effects of blueberries on the health of children who do not eat much fruits and vegetables. By doing this study, we hope to find out what nutrients from blueberries appear in the blood and urine of the child
Read the detailed description
This is a double blinded randomized control trial aiming to characterize the profile of polyphenol-derived metabolites in plasma and urine for children ages 11-12 years supplemented short term with wild blueberry powder. The study will assess if a short-term supplementation (5 days) with wild blueberry powder impacts immune responses as well as markers for cardiovascular and bone health. Up to 44 children will be recruited. The participants will attend three visits at Arkansas Children's Nutrition Center.
- Conditions
- Healthy
- Being tested
- Wild blueberry containing foods, Placebo containing foods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wild blueberry containing foodsDietary supplement
Foods that contain wild blueberry supplement to deliver up to 30 grams of blueberry powder
Placebo containing foodsDietary supplement
Foods that do not contain the blueberry powder but a placebo
| Study group | Role | What they receive |
|---|---|---|
| Wild Blueberry Supplement | Active comparator | 30 grams of wild blueberry powder per day in foods items provided to them Receives: Dietary Supplement: Wild blueberry containing foods |
| Placebo supplement | Placebo comparator | Food items will be provided to them without the wild blueberry power. Receives: Dietary Supplement: Placebo containing foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenolic Acid Metabolites Measured in Plasma and Urine After Dietary Intervention
Fasting Blood and urine were collected at visit two and three following an overnight fasting. At visit three, children consumed a single dose of the study product and plasma and urine were collected
Measured: Measurements were conducted hourly for 5 hours; the cumulative number of metabolites characterized over the 5 hours is reported
Secondary outcomes (3)
Number and Percentage of Lymphocytes Cluster of Differentiation 4 (CD4), Lymphocytes Cluster of Differentiation 8 (CD8) and Natural Killer (NK) Cells
Mitogen stimulated blood will be stained with combinations of fluorochrome-labeled antibodies and analyzed by flow cytometry. Absolute and relative number of CD4, lymphocytes CD8 and natural killer (NK) will be compared between groups.
Measured: up to 2 weeks
T-lymphocyte Responsiveness to Immune Stressors
Blood will be collected following an overnight fast after 5 days on the intervention. Whole blood will be cultured and cells stressed with E. coli lipopolysaccharide (LPS) to induce cytokine release from immune cells. Cytokines will be assayed using electrochemiluminescence based detection platform with multiplexed immunoassays, and their levels compared between study groups.
Measured: up to 2 weeks
Endothelial Function by Brachial Artery Flow Mediated Dilation
Endothelial-dependent flow-mediated vasodilation of the brachial artery in the fasting state was measured using high resolution ultrasound at enrollment and after 5 days on the intervention. This technology uses sound waves (ultrasound) to visualize the diameter of the brachial artery. A baseline image of the brachial artery will be recorded at rest. A blood pressure cuff will be placed around the lower arm and the cuff will be inflated to 50 mmHg above systolic pressure for 5 minutes, followed by rapid deflation of the cuff. The diameter of the brachial artery will be measured from ultrasound images captured throughout the 8 minute recording protocol. The percent change in the brachial artery will be compared between and within groups.
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start23 Apr 2021
- Primary completion18 Aug 2022
- Study completion18 Aug 2022
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Eva Diaz, MD, Principal investigator, Arkansas Children's Reserach Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421950
- Sponsor's protocol ID
- 260493
- Other IDs
- 6026-51000-012-06S, P20GM109096
- Status last verified
- Sep 2024
- First submitted
- 26 May 2020
- Last updated
- 22 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma and Urine Profiles of Blueberry Derived Polyphenols After a Short Term Intervention With Blueberry in Children With Typical Low Fruit and Vegetable Consumption.
- ClinicalTrials.gov ID
- NCT04421950
- Acronym / sponsor ID
- 260493
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), National Institute of General Medical Sciences (NIGMS)
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- 18 Aug 2022 (actual)
- Study completion
- 18 Aug 2022 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Posted 22 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study about the effects of blueberries on the health of children who do not eat much fruits and vegetables. By doing this study, we hope to find out what nutrients from blueberries appear in the blood and urine of the child
Detailed description
This is a double blinded randomized control trial aiming to characterize the profile of polyphenol-derived metabolites in plasma and urine for children ages 11-12 years supplemented short term with wild blueberry powder. The study will assess if a short-term supplementation (5 days) with wild blueberry powder impacts immune responses as well as markers for cardiovascular and bone health. Up to 44 children will be recruited. The participants will attend three visits at Arkansas Children's Nutrition Center.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wild Blueberry Supplement | Active comparator | Dietary Supplement: Wild blueberry containing foods30 grams of wild blueberry powder per day in foods items provided to them |
| Placebo supplement | Placebo comparator | Dietary Supplement: Placebo containing foodsFood items will be provided to them without the wild blueberry power. |
Who may qualify
- Ages
- 11 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Eats <1.5 cup of fruit and <2.0 cup of vegetables per day
- Boys or girls
- All ethnicities
- All BMIs
Key exclusion criteria (16 listed)
- Known allergy to blueberries
- Epilepsy
- Asthma
- Chronic kidney disease
- Hormonal disease
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 |
|---|---|---|
| Wild blueberry containing foodsFoods that contain wild blueberry supplement to deliver up to 30 grams of blueberry powder | Dietary supplement | Wild Blueberry Supplement |
| Placebo containing foodsFoods that do not contain the blueberry powder but a placebo | Dietary supplement | Placebo supplement |
Primary outcome
Phenolic Acid Metabolites Measured in Plasma and Urine After Dietary Intervention
Time frame: Measurements were conducted hourly for 5 hours; the cumulative number of metabolites characterized over the 5 hours is reported
Fasting Blood and urine were collected at visit two and three following an overnight fasting. At visit three, children consumed a single dose of the study product and plasma and urine were collected
3 secondary outcomes
Number and Percentage of Lymphocytes Cluster of Differentiation 4 (CD4), Lymphocytes Cluster of Differentiation 8 (CD8) and Natural Killer (NK) Cells
Time frame: up to 2 weeks
T-lymphocyte Responsiveness to Immune Stressors
Time frame: up to 2 weeks
Endothelial Function by Brachial Artery Flow Mediated Dilation
Time frame: up to 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Eva Diaz, MD principal investigator
Arkansas Children's Reserach Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wild blueberry containing foods in people with Healthy, run by Arkansas Children's Hospital Research Institute 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 4 inclusion and 16 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 22 Aug 2025. 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 22 Aug 2025). 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?
Phenolic Acid Metabolites Measured in Plasma and Urine After Dietary Intervention (time frame: Measurements were conducted hourly for 5 hours; the cumulative number of metabolites characterized over the 5 hours is reported). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2025.