The Blueberry Study

Arkansas Children's Hospital Research Institute

Status: Active, not recruiting

Conditions: Healthy

Treatments: Dietary Supplement: Wild blueberry containing foods; Dietary Supplement: Placebo containing foods

Study type: Interventional

Funder types: Other

Identifiers

NCT04421950

260493

Details and patient eligibility

About

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

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 11 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 2 patient groups, including a placebo group

Wild Blueberry Supplement

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Wild blueberry containing foods

Placebo supplement

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo containing foods