The Health Effects of a Blueberry Enriched Diet on Obese Children (Wild Blueberry)
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|ClinicalTrials.gov Identifier: NCT01809795|
Recruitment Status : Completed
First Posted : March 13, 2013
Last Update Posted : December 18, 2014
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Other: Blueberry Smoothie Other: Sham Smoothie||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Health Effects of a Blueberry Enriched Diet on Obese Children: A Feasibility Study|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||December 2014|
Experimental: Blueberry Smoothie
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
Sham Comparator: Sham Smoothie
Participants in this group will receive a smoothie that contains no blueberries.
Other: Sham Smoothie
- 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 ]
- Vascular Function [ Time Frame: 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.
- Graded Exercise Test [ Time Frame: Baseline and after 12 week program ]Exercise data: graded exercise test with submaximal VO2 measure at 6 and 9 minutes, VO2 max values.
- Cognitive Function/Memory [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline and after 12 week program ]Laboratory testing: fasting blood sugar, insulin, HDL, LDL, Total Cholesterol, Triglycerides, HgA1C, AST, ALT, GGT for research purposes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809795
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Robert Siegel, MD||Children's Hospital Medical Center, Cincinnati|