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

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01553370
• Other study ID #: BUCT-11-221
• Status: Not yet recruiting
• Phase: N/A
• First received: March 12, 2012
• Last updated: March 13, 2012
• Start date: April 2012
• Est. completion date: February 2013

Study information

• Verified date: March 2012
• Source: Brock University
• Contact: Brian D Roy, PhD
• Phone: 905-688-5550
• Email: broy[@]brocku.ca
• Is FDA regulated: No
• Health authority: Canada: Brock University Bioscience Research Ethics BoardCanada: Hamilton Health Sciences/McMaster University Faculty of Health Sciences Research Ethics Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 28 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Overweight

Intervention

Other:
• Increased Dairy Intake
3 additional servings of low fat dairy will be consumed
• Supplemental carbohydrate
Maltodextrin will be provided in an amount equal to the the energy content in the 3 supplemental servings of low-fat dairy.

Locations

Country	Name	City	State
Canada	Brock University	St. Catharines	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Brock University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body composition		12 weeks	No
Primary	Bone mineral density		12 weeks	No
Primary	VO2 peak		12 weeks	No
Secondary	mitochondrial enzyme activity		12 weeks	No
Secondary	muscle oxidative stress		12 weeks	No
Secondary	muscle capillary density		12 weeks	No
Secondary	blood lipids		12 weeks	No
Secondary	blood inflammatory markers		12 weeks	No
Secondary	blood markers of bone turnover		12 weeks	No

External Links

•   Sponsor of the trial
•   University website