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Completed

NCT Number: NCT01809795

The Health Effects of a Blueberry Enriched Diet on Obese Children

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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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blueberry Smoothie

Other

Sham Smoothie

Other

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Pennington Biomedical Research Center

Registry information

Official study title

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

Acronym: Wild Blueberry

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Mar 13, 2013
Registry last updated
Dec 18, 2014

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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