The Blueberry Study

NCT04421950 | Completed Results

• 3 other identifiers: 2604936026-51000-012-06SP20GM109096
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

  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

  up to 2 weeks

• T-lymphocyte Responsiveness to Immune Stressors

  up to 2 weeks

• Endothelial Function by Brachial Artery Flow Mediated Dilation

  up to 2 weeks

Study Arms (2)

Wild Blueberry Supplement

ACTIVE COMPARATOR

30 grams of wild blueberry powder per day in foods items provided to them

Dietary Supplement: Wild blueberry containing foods

Placebo supplement

PLACEBO COMPARATOR

Food items will be provided to them without the wild blueberry power.

Dietary Supplement: Placebo containing foods

Interventions

Wild blueberry containing foods DIETARY_SUPPLEMENT

Foods that contain wild blueberry supplement to deliver up to 30 grams of blueberry powder

Wild Blueberry Supplement

Placebo containing foods DIETARY_SUPPLEMENT

Foods that do not contain the blueberry powder but a placebo

Placebo supplement

Eligibility Criteria

• Age: 11 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead
• United States Department of Agriculture (USDA): collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

Location

Results Point of Contact

• Title: Eva C. Diaz, Principal Investigator
• Organization: University of Arkansas for Medical Sciences and Arkansas Children's Nutrition Ce

ecdiazfuentes@uams.edu

5013643056

Study Officials

• Eva Diaz, MD

  Arkansas Children's Reserach Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double blinded randomized control
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 9, 2020
• Study Start: April 23, 2021
• Primary Completion: August 18, 2022
• Study Completion: August 18, 2022
• Last Updated: August 22, 2025
• Results First Posted: August 22, 2025

Record last verified: 2024-09

Locations

US (1)