N/A N=44 Randomized Triple-blind Prevention

The Blueberry Study

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT04421950 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2025

Primary outcome: Primary: Phenolic Acid Metabolites Measured in Plasma and Urine After Dietary Intervention — 13; 0; 25; 3 Counts of metabolites

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Wild blueberry containing foods (Dietary_supplement); Placebo containing foods (Dietary_supplement)
Age: Pediatric · 11+ yrs
Sex: All
Sponsor: Arkansas Children's Hospital Research Institute
Primary completion: Aug 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Phenolic Acid Metabolites Measured in Plasma and Urine After Dietary Intervention	13; 0; 25; 3	—
SECONDARY Number and Percentage of Lymphocytes Cluster of Differentiation 4 (CD4), Lymphocytes Cluster of Differentiation 8 (CD8) and Natural Killer (NK) Cells	—	—
SECONDARY T-lymphocyte Responsiveness to Immune Stressors	—	—
SECONDARY Endothelial Function by Brachial Artery Flow Mediated Dilation	9.4; 9.4	<0.05 sig

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

Eligibility Criteria

Inclusion Criteria

Eats <1.5 cup of fruit and <2.0 cup of vegetables per day
Boys or girls
All ethnicities
All BMIs

Exclusion Criteria

Known allergy to blueberries
Epilepsy
Asthma
Chronic kidney disease
Hormonal disease
Autoimmune disease
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04421950). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.