Body Composition Clinical Trial
Official title:
Effects of Resistance Training With Milk Supplementation on Body Composition in Middle School Children
The investigators primary objective is to evaluate the effect of a 6 month (3 days/wk) supervised, progressive RT program with increased daily milk intake in untrained adolescents on measures of body composition and cardiovascular risk factors. The investigators hypothesize that milk supplementation will produce significantly greater favorable changes in all body composition measures compared with RT + carbohydrate and control.
Status | Completed |
Enrollment | 150 |
Est. completion date | May 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 12 Years to 14 Years |
Eligibility |
Inclusion Criteria: 1. Middle school student (Grades 7-9) 2. BMI > 50th percentile - < 98th percentile 3. No resistance training in the past 6 months. 4. Endurance training (running, cycling, swimming, walking for exercise etc) not more than 3 hr per week, as assessed by screening questionnaire. 5. Weight stable (+/- 4.5kg) for 3 months prior to intake. 6. Willing to be randomized to one of the 3 study groups. Exclusion criteria: 1. Individuals with contraindications based on review of health history by the investigators, including blood pressure, lipid profile, glucose, and insulin, and abnormal values obtained in a 24 item blood panel, such as electrolytes, liver function, etc. These individuals will be referred to their primary care physician for further evaluation and to obtain permission to participate. The following cut-points will be used for cardiovascular and metabolic parameters: dyslipidemia- lipids (cholesterol > 240 mg/L; triglycerides >500 mg/L), hypertension- systolic blood pressure > 140 mmHG or diastolic blood pressure > 90 mmHG, diabetes - fasting glucose from venous plasma fasting glucose > 126 mg/dL. 2. Medications that could affect metabolism such as cardiac drugs, thyroid, steroids, insulin, beta blockers, SSRI's, birth control pills, etc. 3. Current use of smoking/tobacco products or initiation of smoking/tobacco during the study. 4. Eating disorders as determined by screening questionnaire 5. Adherence to specialized diet regimes, vegetarian, macrobiotic, etc. 6. Food allergies, particularly lactose intolerance. 7. Treatment for psychiatric illness of chemical dependency within the previous 6 months. 8. Pregnancy or lactation. 9. Dietary intake of =800 mg calcium and =1 servings of milk per day as assessed from 3 -24 hr diet recalls (2 week-days, 1 week-end day) conducted at baseline. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | University of Kansas Medical Center | Kansas City | Kansas |
Lead Sponsor | Collaborator |
---|---|
University of Kansas Medical Center | Dairy Management Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body Composition | Changes in body composition will be evaluated by measuring the change in percent body fat, total fat mass, and total lean mass by DEXA | 6 months | No |
Secondary | Blood lipids, glucose, and insulin | Blood samples will be collected for the purpose of measuring triglycerides, total cholesterol, HDL-cholesterol, glucose and insulin. | 6 months | No |
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