Randomized Controlled Trial of Milk Products and Physical Activity on Body Composition and Health in Overweight Young Males

Study Overview
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Brief Summary
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Maintaining a healthy body weight is a major challenge for the majority of Canadians. A lifestyle strategy that promotes maintenance of a healthy body weight and, perhaps most importantly, can be incorporated into daily life with relative ease is essential. This study will determine if an effective strategy includes increased physical activity in conjunction with higher intakes of dairy products immediately following exercise. Fifty-six overweight adult males who do not regularly exercise will be assigned to one of four groups for 12 weeks. All groups will preform 12 weeks of exercise training (1 hour of cycling per day, 5 times per week). Two groups will consume supplemental low fat milk (3 servings per day) with one these groups consuming it immediately after exercise while the other will consume it either well before or long after the exercise session. The other two groups will consume a carbohydrate drink that has the same amount of energy as the low fat milk, with one of these groups consuming the drink right after exercise and the other another group will consume it either well before or long after the exercise session. Markers of health status including body weight, muscle mass, and bone mass will be measured at the start and after the 12- week intervention. The investigators anticipate that providing the low fat milk immediately after exercise will result in the most favorable changes in health outcomes, and provide a realistic lifestyle intervention for overweight individuals to attain a healthy body weight, and by doing so, optimize their ability to prevent chronic disease.

Official Title
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Randomized Controlled Trial of Milk Products and Physical Activity on Body Composition and Health in Overweight Young Males

Conditions
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Overweight

Intervention / Treatment
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* Other: Increased Dairy Intake
* Other: Supplemental carbohydrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI greater or equal to 25 healthy Exclusion Criteria: any chronic cardiovascular condition or metabolic condition kidney disease gastro-intestinal disease milk or dairy protein allergies lactose intolerance chronic lung conditions any condition that could potentially prevent participant from performing exercise allergy to local anaesthetics cumulative x-ray exposure and cumulative muscle biopsies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 28 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alternate Intake-time<br> | Other: Increased Dairy Intake<br>* 3 additional servings of low fat dairy will be consumed<br>Other: Supplemental carbohydrate<br>* Maltodextrin will be provided in an amount equal to the the energy content in the 3 supplemental servings of low-fat dairy.<br>|
| Experimental: Immediately post-exercise<br> | Other: Increased Dairy Intake<br>* 3 additional servings of low fat dairy will be consumed<br>Other: Supplemental carbohydrate<br>* Maltodextrin will be provided in an amount equal to the the energy content in the 3 supplemental servings of low-fat dairy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition |  | 12 weeks | 
| Bone mineral density |  | 12 weeks | 
| VO2 peak |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mitochondrial enzyme activity |  | 12 weeks | 
| muscle oxidative stress |  | 12 weeks | 
| muscle capillary density |  | 12 weeks | 
| blood lipids |  | 12 weeks | 
| blood inflammatory markers |  | 12 weeks | 
| blood markers of bone turnover |  | 12 weeks |