The Health Effects of a Blueberry Enriched Diet on Obese Children

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Other: Sham Smoothie; Other: Blueberry Smoothie

• Registration Number: NCT01809795
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-02-06
• Study Start: 2013-03
• Study First Submitted QC: 2013-03-11
• Study First Posted: 2013-03-13
• Primary Completion: 2013-10
• Status Verified: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-16
• Last Update Posted: 2014-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Smoothie	Sham Smoothie	Participants in this group will receive a smoothie that contains no blueberries.
Blueberry Smoothie	Blueberry Smoothie	Participants in this group will receive a smoothie containing 1 1/2 cups of freeze-dried whole blueberries crushed into a powder.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States