NCT04421950

The Blueberry Study

Completed NA Results posted Last updated 22 August 2025

What this trial tests

NA trial testing Wild blueberry containing foods in Healthy in 44 participants. Completed in 18 August 2022.

Timeline

23 April 2021

Primary endpoint
18 August 2022

18 August 2022

Quick facts

Lead sponsor	Arkansas Children's Hospital Research Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	44
Start date	23 April 2021
Primary completion	18 August 2022
Estimated completion	18 August 2022
Sites	1 location across United States

Drugs / interventions tested

• Wild blueberry containing foods
• Placebo containing foods

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Arkansas Children's Hospital Research Institute

Who can join

Adults 11 to 12, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Phenolic Acid Metabolites Measured in Plasma and Urine After Dietary Intervention Primary · 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

Plasma

Group	Value	95% CI
Wild Blueberry Supplement	13
Placebo Supplement	0

Urine

Group	Value	95% CI
Wild Blueberry Supplement	25
Placebo Supplement	3

Endothelial Function by Brachial Artery Flow Mediated Dilation Secondary · up to 2 weeks

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

Group	Value	95% CI
Wild Blueberry Supplement	9.4	± 3.4
Placebo Supplement	9.4	± 3.0

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year, 4 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Wild Blueberry Supplement

Serious: 0/22 (0%)

Deaths: 0/22

Placebo Supplement

Serious: 0/22 (0%)

Deaths: 0/22

Other adverse events (2 terms — click to expand)

Reaction	System	Wild Blueberry Supplement	Placebo Supplement
High blood pressure	General disorders	—	—
Gastrointestinal symptoms	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT04421950 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.