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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
Sponsor:
Collaborator:
Pennington Biomedical Research Center
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obesity Other: Blueberry Smoothie Other: Sham Smoothie Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Pennington Biomedical Research Center
Investigators
Principal Investigator: Robert Siegel, MD Children's Hospital Medical Center, Cincinnati

Publications:

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01809795     History of Changes
Other Study ID Numbers: 2012-4400
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: December 18, 2014
Last Verified: December 2014

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Obesity
Exercise
Blueberry Plant