Randomized Controlled Trial of Milk Products and Physical Activity on Body Composition and Health in Overweight Young Males
Primary Purpose
Overweight
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Increased Dairy Intake
Supplemental carbohydrate
Sponsored by
About this trial
This is an interventional prevention trial for Overweight
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
Sites / Locations
- Brock University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Alternate Intake-time
Immediately post-exercise
Arm Description
Outcomes
Primary Outcome Measures
Body composition
Bone mineral density
VO2 peak
Secondary Outcome Measures
mitochondrial enzyme activity
muscle oxidative stress
muscle capillary density
blood lipids
blood inflammatory markers
blood markers of bone turnover
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01553370
Brief Title
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
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
February 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brock University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Alternate Intake-time
Arm Type
Active Comparator
Arm Title
Immediately post-exercise
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Increased Dairy Intake
Intervention Description
3 additional servings of low fat dairy will be consumed
Intervention Type
Other
Intervention Name(s)
Supplemental carbohydrate
Intervention Description
Maltodextrin will be provided in an amount equal to the the energy content in the 3 supplemental servings of low-fat dairy.
Primary Outcome Measure Information:
Title
Body composition
Time Frame
12 weeks
Title
Bone mineral density
Time Frame
12 weeks
Title
VO2 peak
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
mitochondrial enzyme activity
Time Frame
12 weeks
Title
muscle oxidative stress
Time Frame
12 weeks
Title
muscle capillary density
Time Frame
12 weeks
Title
blood lipids
Time Frame
12 weeks
Title
blood inflammatory markers
Time Frame
12 weeks
Title
blood markers of bone turnover
Time Frame
12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian D Roy, PhD
Phone
905-688-5550
Ext
3779
Email
broy@brocku.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Wendy Ward, PhD
Phone
905-688-5550
Ext
3024
Email
wward@brocku.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian D Roy, PhD
Organizational Affiliation
Brock University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brock University
City
St. Catharines
State/Province
Ontario
ZIP/Postal Code
L2S 3A1
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian D Roy, PhD
Phone
905-688-5550
Ext
3779
Email
broy@brocku.ca
First Name & Middle Initial & Last Name & Degree
Brian D Roy, PhD
First Name & Middle Initial & Last Name & Degree
Wendy Ward, PhD
12. IPD Sharing Statement
Links:
URL
http://www.brocku.ca
Description
University website
URL
http://www.dairyfarmers.ca/
Description
Sponsor of the trial
Learn more about this trial
Randomized Controlled Trial of Milk Products and Physical Activity on Body Composition and Health in Overweight Young Males
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