The Blueberry Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-23

Study Completion Date

2022-08-18

Brief Summary

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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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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Double blinded randomized control

Study Groups

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Wild Blueberry Supplement

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

Group Type ACTIVE_COMPARATOR

Wild blueberry containing foods

Intervention Type DIETARY_SUPPLEMENT

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

Placebo supplement

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

Group Type PLACEBO_COMPARATOR

Placebo containing foods

Intervention Type DIETARY_SUPPLEMENT

Foods that do not contain the blueberry powder but a placebo

Interventions

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Wild blueberry containing foods

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

Intervention Type DIETARY_SUPPLEMENT

Placebo containing foods

Foods that do not contain the blueberry powder but a placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

11 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes