Clinical trial NCT01553370: Randomized Controlled Trial of Milk Products and Physical Activity on Body Composition and Health in Overweight Young Males
Official title: Randomized Controlled Trial of Milk Products and Physical Activity on Body Composition and Health in Overweight Young Males
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight
Lead sponsor: Brock University
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Body composition
timeFrame: 12 weeks
measure: Bone mineral density
timeFrame: 12 weeks
measure: VO2 peak
timeFrame: 12 weeks
Secondary outcomes:
measure: mitochondrial enzyme activity
timeFrame: 12 weeks
measure: muscle oxidative stress
timeFrame: 12 weeks
measure: muscle capillary density
timeFrame: 12 weeks
measure: blood lipids
timeFrame: 12 weeks
measure: blood inflammatory markers
timeFrame: 12 weeks
measure: blood markers of bone turnover
timeFrame: 12 weeks
Other outcomes:
Locations:
city: St. Catharines
country: Canada
facility: Brock University
state: Ontario
Study officials:
affiliation: Brock University
name: Brian D Roy, PhD
role: PRINCIPAL_INVESTIGATOR
References: