The Blueberry Study

Not Applicable

Active, not recruiting

• Conditions: Healthy
• Interventions: Dietary Supplement: Placebo containing foods; Dietary Supplement: Wild blueberry containing foods

• Registration Number: NCT04421950
• Lead Sponsor: Arkansas Children's Hospital Research Institute

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

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 Timeline

• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-09
• Study Start: 2021-04-23
• Primary Completion: 2023-09-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01
• Study Completion: 2024-12-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo supplement	Placebo containing foods	Food items will be provided to them without the wild blueberry power.
Wild Blueberry Supplement	Wild blueberry containing foods	30 grams of wild blueberry powder per day in foods items provided to them

Primary Outcome Measures

Name	Time	Method
Plasma and urine levels of blueberry derived polyphenols and their metabolites	up to 2 weeks	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

Secondary Outcome Measures

Name	Time	Method
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	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.
T-lymphocyte responsiveness to immune stressors	up to 2 weeks	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.
Endothelial function by brachial artery flow mediated dilation	up to 2 weeks	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.

Trial Locations

Locations (1)

Arkansas Children's Nutrition Center; 🇺🇸 Little Rock, Arkansas, United States