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Completed

NCT Number: NCT04421950

The Blueberry Study

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

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Key information

Conditions

Healthy

Age range

11 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wild blueberry containing foods

Dietary Supplement

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

Placebo containing foods

Dietary Supplement

Foods that do not contain the blueberry powder but a placebo

Primary outcomes

  1. Phenolic Acid Metabolites Measured in Plasma and Urine After Dietary Intervention

    Time frame: 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

Secondary outcomes

  1. Number and Percentage of Lymphocytes Cluster of Differentiation 4 (CD4), Lymphocytes Cluster of Differentiation 8 (CD8) and Natural Killer (NK) Cells

    Time frame: 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.

  2. T-lymphocyte Responsiveness to Immune Stressors

    Time frame: 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.

  3. Endothelial Function by Brachial Artery Flow Mediated Dilation

    Time frame: 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 images captured throughout the 8 minute recording protocol. The percent change in the brachial artery will be compared between and within groups.

Sponsors and collaborators

Lead sponsor

Arkansas Children's Hospital Research Institute

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)
  • United States Department of Agriculture (USDA)

Registry information

Official study title

Plasma and Urine Profiles of Blueberry Derived Polyphenols After a Short Term Intervention With Blueberry in Children With Typical Low Fruit and Vegetable Consumption.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 9, 2020
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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