The Blueberry Study

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

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Wild blueberry containing foods; Dietary supplement: Placebo containing foods

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jill A Gassaway, BS; Phone Number: 5013643309; Email: acncstudies@archildrens.org
• Study Contact Backup: Name: Ashton Adkison, BS; Phone Number: 5013643309; Email: acncstudies@archildrens.org

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Nutrition Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Wild Blueberry Supplement; 30 grams of wild blueberry powder per day in foods items provided to them	Dietary supplement: Wild blueberry containing foods; Foods that contain wild blueberry supplement to deliver up to 30 grams of blueberry powder
Placebo Comparator: Placebo supplement; Food items will be provided to them without the wild blueberry power.	Dietary supplement: Placebo containing foods; Foods that do not contain the blueberry powder but a placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma and urine levels of blueberry derived polyphenols and their metabolites	Blood will be collected twice following an overnight fast. Twelve-hour urine will be collected twice by participants at home. Plasma and urine samples will be analyzed using mass spectrometry to identify blueberry-derived polyphenols and their levels	up to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 2 weeks
Endothelial function by brachial artery flow mediated dilation	Endothelial-dependent flow-mediated vasodilation of the brachial artery will be 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.	up to 2 weeks
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.	up to 2 weeks

Collaborators and Investigators

• Sponsor: Arkansas Children's Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2021
• Primary Completion (Actual): September 1, 2023
• Study Completion (Estimated): December 20, 2024

Study Registration Dates

• First Submitted: May 26, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 260493

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No