The Blueberry Study

Healthy Clinical Trial

Official 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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04421950
• Other study ID #: 260493
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 23, 2021
• Est. completion date: December 20, 2024

Study information

• Verified date: January 2024
• Source: Arkansas Children's Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: December 20, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Wild blueberry containing foods
Foods that contain wild blueberry supplement to deliver up to 30 grams of blueberry powder
• Placebo containing foods
Foods that do not contain the blueberry powder but a placebo

Locations

Country	Name	City	State
United States	Arkansas Children's Nutrition Center	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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