Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
NCT Number: NCT01809795
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.
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Notify Me12 year–17 year
All sexes
Interventional
Not applicable
Cincinnati, Ohio, 45229, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 12 weeks
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.
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.
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.
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.
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.
Children's Hospital Medical Center, Cincinnati
Other
The Health Effects of a Blueberry Enriched Diet on Obese Children: A Feasibility Study
Acronym: Wild Blueberry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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