The Health Effects of a Blueberry Enriched Diet on Obese Children

Study Overview
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Brief Summary
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The purpose of this study to determine if adding blueberries to obese children's diet will improve weight status and other medical testing. We would also like to determine if a larger research study involving blueberries is possible.

Detailed Description
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Ten children aged 12 to 17 years of age who have a BMI > 95th percentile for age and who are patients of the Center for Better Health and Nutrition will be recruited for this 12 week study. Group 1 (Standard Therapy): Participants will be asked not to consume berries during the study so as not to confound the effects of eating blueberries. They will, however, be encouraged to consume other fruits consistent with nutrition guidelines for the Healthy Eating Plan (HEP: reduced glycemic load diet). Participants will be instructed and receive educational handout materials on implementing HEP. In addition participants will be introduced to the use of behavioral tools (e.g. goal setting, daily tracking when goals are met, and incentives provided by the family) to help them stay on track with HEP. Participants will be seen by the dietitian at monthly intervals consistent with programmatic standard of care to review adherence to HEP, use of behavioral tools, and change in weight status. Participants will be encouraged to attend group exercise classes five days per week or a minimum of four days per week. At the end of each exercise session, participants will receive a sham smoothie which contains no blueberries. The children will be directly observed by a study worker when consuming the smoothies to ensure compliance and measure how much of the smoothie was consumed. Group 2 (Blueberry Enhanced): All the features of Group 1 with the exception that the participants will be given a smoothie that contain 1 1/2 cups of freeze-dried whole blueberries crushed into a powder per serving.

Official Title
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The Health Effects of a Blueberry Enriched Diet on Obese Children: A Feasibility Study

Conditions
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Obesity

Intervention / Treatment
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* Other: Blueberry Smoothie
* Other: Sham Smoothie


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children 12 to 17 years old at the time of enrollment Children with a BMI ≥ 95th percentile for age Children participating in a weight management program at the CBHN. Exclusion Criteria: Children/parents/guardians who appear unable to understand the study Children/parents appear unable to meet the requirements of participating, specifically not missing more than 1 consecutive week during the 12 week intervention Children who have a medical condition or development impairment that precludes them from participating in an exercise program Children who have type 2 diabetes Children who have been diagnosed with hypertension Children who are taking a statin Children who are pregnant or have given birth within 6 months Children with a history of significant cardiac disease leading to cardiovascular instability Children who have food allergies or are lactose intolerant Children who are unable to finish at least half of the smoothie while they taste it after the consent/assent process or decide after tasting the smoothie that they are no longer interested in participating.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blueberry Smoothie<br>Participants in this group will receive a smoothie containing 1 1/2 cups of freeze-dried whole blueberries crushed into a powder. | Other: Blueberry Smoothie<br> <br> |
| Sham Comparator: Sham Smoothie<br>Participants in this group will receive a smoothie that contains no blueberries. | Other: Sham Smoothie<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attendance and compliance to healthy eating plan, group exercise class and smoothie consumption will be measured to assess feasibility of larger, randomized study. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular Function | Vascular Function Testing: augmentation index, Brachial Arterial Distensibility, Pulse Wave Velocity, EndoPAT, Laser Flow Doppler, Ultrasound Brachial Flow Mediated Dilation. | Baseline and after 12 week program | 
| Graded Exercise Test | Exercise data: graded exercise test with submaximal VO2 measure at 6 and 9 minutes, VO2 max values. | Baseline and after 12 week program | 
| Cognitive Function/Memory | Cognitive Function/Memory-CVLT and D-KFES at the initial medical evaluation and the WRAMIL 2-D-KFES Alternative Version at the final medical evaluation. | Baseline and after 12 week program | 
| Anthropometric Measurements | Anthropometrics and clinical measurements: height, weight, BMI, BMI percentile, waist circumference, blood pressure, percent body fat by bioimpedance. | Baseline and after 12 week program | 
| Laboratory Testing | Laboratory testing: fasting blood sugar, insulin, HDL, LDL, Total Cholesterol, Triglycerides, HgA1C, AST, ALT, GGT for research purposes. | Baseline and after 12 week program | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Exercise, Blueberry Plant