Clinical trial NCT01186536: Whey Protein, Resistance Training, and Changes in Body Composition
Official title: Whey Protein Supp. w/ Resistance Training; Effects on Body Comp. of Young Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Whey Protein
Soy Protein
Resistance training
Weight Management
Lead sponsor: University of Kansas
Sponsor class: OTHER
Collaborators: name: Dairy Management Inc.
First posted: 2010-08-23
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this project is to determine the effect of 9 months of progressive resistance training with daily whey protein supplements on the body composition (changes in muscle and fat) in young adults. The investigators hypothesize that those individuals who receive whey protein supplements will have larger gains in muscle and larger losses of fat tissue in response to resistance training compared to those who receive supplements of soy or carbohydrate.

Detailed description: Healthy men and women will be recruited to participate in 9 months of supervised resistance training (3 days/wk) and will be randomized to one of three daily supplement groups: Whey protein, soy protein, or carbohydrate control. Body weight, muscular strength and endurance, and resting blood pressure will be assessed at baseline, 3, 6 and 9 months. Body composition will be assessed at baseline, 3, 5, 7, and 9 months. A sub-sample (N = 17 per group, assessed at baseline and 9 months) will be randomly selected for muscle samples of the upper leg to determine changes in the size of muscle fibers, and chemical factors associated with muscle growth. Blood samples will be obtained from sub-sample participants to assess changes in glucose and fat metabolism, as well as other chemicals likely to promote or inhibit muscle growth. We will also assess changes in daily energy expenditure and the use of fuel to produce energy (carbohydrate, fat, protein) that may result from the intervention. We hypothesize that those individuals who receive whey protein supplements will have larger gains in muscle and larger losses of fat tissue in response to resistance training compared to those who receive supplements of soy or carbohydrate.

Eligibility criteria: Inclusion Criteria:

* BMI 25-39.9
* must be 18- 30 years old
* sedentary
* no medications
* stable weight for at least 3 months

Exclusion Criteria:

* Tobacco/Drug user
* metabolism altering medication
* gain/lost 10lbs in the last 3 months
* current exerciser

Primary outcomes:
measure: Body Composition
timeFrame: 9 months
Secondary outcomes:
measure: 24 hour energy expenditure and substrate oxidation
timeFrame: 9 months
measure: Muscular strength and endurance
timeFrame: 9 months
measure: Resting Metabolic Rate
timeFrame: 9 months
Other outcomes:
Locations:
city: Lawrence
country: United States
facility: Energy Balance Lab, The University of Kansas
state: Kansas
Study officials:
affiliation: University of Kansas
name: Richard A. Washburn, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: