Resistance Training With Milk Supplementation in Adolescents

NCT01190592 | Completed DMC

• 1 other identifier: 11935
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Body Composition; Cardiovascular Risk Factors

Keywords

Resistance training; Body Composition; Cardiovascular Risk factors; Dairy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Blood lipids, glucose, and insulin

  6 months

Study Arms (3)

Milk

EXPERIMENTAL

Other: Resistance Training with Milk Supplementation in Adolescents

Juice

EXPERIMENTAL

Other: Resistance Training with Milk Supplementation in Adolescents

Water

PLACEBO COMPARATOR

Other: Resistance Training with Milk Supplementation in Adolescents

Interventions

Resistance Training with Milk Supplementation in Adolescents OTHER

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.

Juice; Milk; Water

Eligibility Criteria

• Age: 12 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Middle school student (Grades 7-9)
• BMI \> 50th percentile - \< 98th percentile
• No resistance training in the past 6 months.
• Endurance training (running, cycling, swimming, walking for exercise etc) not more than 3 hr per week, as assessed by screening questionnaire.
• Weight stable (+/- 4.5kg) for 3 months prior to intake.
• Willing to be randomized to one of the 3 study groups.

You may not qualify if:

• 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.
• Medications that could affect metabolism such as cardiac drugs, thyroid, steroids, insulin, beta blockers, SSRI's, birth control pills, etc.
• Current use of smoking/tobacco products or initiation of smoking/tobacco during the study.
• Eating disorders as determined by screening questionnaire
• Adherence to specialized diet regimes, vegetarian, macrobiotic, etc.
• Food allergies, particularly lactose intolerance.
• Treatment for psychiatric illness of chemical dependency within the previous 6 months.
• Pregnancy or lactation.
• 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.

Sponsors & Collaborators

• University of Kansas: lead
• Dairy Management Inc.: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Joseph Donnelly, Ed.D

  University of Kansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 26, 2010
• First Posted: August 27, 2010
• Study Start: October 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 21, 2011

Record last verified: 2011-06

Locations

US (1)