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Resistance Training With Milk Supplementation in Adolescents

This study has been completed.
Sponsor:
Collaborator:
Dairy Management Inc.
Information provided by:
University of Kansas
ClinicalTrials.gov Identifier:
NCT01190592
First received: August 26, 2010
Last updated: June 20, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention
Body Composition
Cardiovascular Risk Factors
 Other: Resistance Training with Milk Supplementation in Adolescents

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of Resistance Training With Milk Supplementation on Body Composition in Middle School Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Body Composition [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Changes in body composition will be evaluated by measuring the change in percent body fat, total fat mass, and total lean mass by DEXA


Secondary Outcome Measures:
  • Blood lipids, glucose, and insulin [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Blood samples will be collected for the purpose of measuring triglycerides, total cholesterol, HDL-cholesterol, glucose and insulin.


Estimated Enrollment: 150
Study Start Date: October 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Milk Other: Resistance Training with Milk Supplementation in Adolescents

On resistance training days, the RT+ milk group will receive milk (280kcals) immediately following exercise and milk at another time during the day. The RT+ juice group will receive fruit juice immediately following resistance exercise and juice again another time during the day. The RT+ water group will receive water following resistance exercise and water at another time during the day.

On non training days, students in the RT+ milk group will receive milk. Students in the RT+ juice group will receive juice. The RT+ water group will receive water during the school day. On non-RT days, the total volume of milk, juice, or water will be split into two administration times during the school day.
Experimental: Juice Other: Resistance Training with Milk Supplementation in Adolescents

On resistance training days, the RT+ milk group will receive milk (280kcals) immediately following exercise and milk at another time during the day. The RT+ juice group will receive fruit juice immediately following resistance exercise and juice again another time during the day. The RT+ water group will receive water following resistance exercise and water at another time during the day.

On non training days, students in the RT+ milk group will receive milk. Students in the RT+ juice group will receive juice. The RT+ water group will receive water during the school day. On non-RT days, the total volume of milk, juice, or water will be split into two administration times during the school day.
Placebo Comparator: Water Other: Resistance Training with Milk Supplementation in Adolescents

On resistance training days, the RT+ milk group will receive milk (280kcals) immediately following exercise and milk at another time during the day. The RT+ juice group will receive fruit juice immediately following resistance exercise and juice again another time during the day. The RT+ water group will receive water following resistance exercise and water at another time during the day.

On non training days, students in the RT+ milk group will receive milk. Students in the RT+ juice group will receive juice. The RT+ water group will receive water during the school day. On non-RT days, the total volume of milk, juice, or water will be split into two administration times during the school day.

Detailed Description:

We will recruit 150 healthy, adolescent middle school boys and girls (grades 7 through 9), BMI > 50th percentile < 98th percentile, who will participate in 6 months of supervised resistance training (3 days/wk) and will be randomized to one of 3 groups: RT + milk, RT + isocaloric carbohydrate, RT only (control). Both physical activity and diet outside the study protocol will be carefully monitored. Measurements will be completed at baseline 3 months and upon completion of the training protocol at 6 months.

  Eligibility

Ages Eligible for Study:   12 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01190592

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
Dairy Management Inc.
Investigators
Principal Investigator: Joseph Donnelly, Ed.D University of Kansas
  More Information

No publications provided

Responsible Party: Joesph E. Donnelly & Richard Washburn, University of Kansas
ClinicalTrials.gov Identifier: NCT01190592     History of Changes
Obsolete Identifiers: NCT01787734
Other Study ID Numbers: 11935
Study First Received: August 26, 2010
Last Updated: June 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
Resistance training
Body Composition
Cardiovascular Risk factors
Dairy

ClinicalTrials.gov processed this record on May 16, 2013