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The Health Effects of a Blueberry Enriched Diet on Obese Children (Wild Blueberry)

Primary Purpose

Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Blueberry Smoothie

Sham Smoothie

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Exercise, Blueberry Plant

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Blueberry Smoothie

Sham Smoothie

Arm Description

Participants in this group will receive a smoothie containing 1 1/2 cups of freeze-dried whole blueberries crushed into a powder.

Participants in this group will receive a smoothie that contains no blueberries.

Outcomes

Primary Outcome Measures

Attendance and compliance to healthy eating plan, group exercise class and smoothie consumption will be measured to assess feasibility of larger, randomized study.

Secondary Outcome Measures

Vascular Function

Vascular Function Testing: augmentation index, Brachial Arterial Distensibility, Pulse Wave Velocity, EndoPAT, Laser Flow Doppler, Ultrasound Brachial Flow Mediated Dilation.

Graded Exercise Test

Exercise data: graded exercise test with submaximal VO2 measure at 6 and 9 minutes, VO2 max values.

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.

Anthropometric Measurements

Anthropometrics and clinical measurements: height, weight, BMI, BMI percentile, waist circumference, blood pressure, percent body fat by bioimpedance.

Laboratory Testing

Laboratory testing: fasting blood sugar, insulin, HDL, LDL, Total Cholesterol, Triglycerides, HgA1C, AST, ALT, GGT for research purposes.

Full Information

NCT ID

NCT01809795

First Posted

February 6, 2013

Last Updated

December 16, 2014

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

Pennington Biomedical Research Center

1. Study Identification

Unique Protocol Identification Number

NCT01809795

Brief Title

The Health Effects of a Blueberry Enriched Diet on Obese Children

Acronym

Wild Blueberry

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

Pennington Biomedical Research Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

Obesity, Exercise, Blueberry Plant

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Blueberry Smoothie

Arm Type

Experimental

Arm Description

Participants in this group will receive a smoothie containing 1 1/2 cups of freeze-dried whole blueberries crushed into a powder.

Arm Title

Sham Smoothie

Arm Type

Sham Comparator

Arm Description

Participants in this group will receive a smoothie that contains no blueberries.

Intervention Type

Other

Intervention Name(s)

Blueberry Smoothie

Intervention Type

Other

Intervention Name(s)

Sham Smoothie

Primary Outcome Measure Information:

Title

Attendance and compliance to healthy eating plan, group exercise class and smoothie consumption will be measured to assess feasibility of larger, randomized study.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Vascular Function

Description

Vascular Function Testing: augmentation index, Brachial Arterial Distensibility, Pulse Wave Velocity, EndoPAT, Laser Flow Doppler, Ultrasound Brachial Flow Mediated Dilation.

Time Frame