- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01553370
Randomized Controlled Trial of Milk Products and Physical Activity on Body Composition and Health in Overweight Young Males
March 13, 2012 updated by: Brian Roy, Brock University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Brian D Roy, PhD
- Phone Number: 3779 905-688-5550
- Email: broy@brocku.ca
Study Contact Backup
- Name: Wendy Ward, PhD
- Phone Number: 3024 905-688-5550
- Email: wward@brocku.ca
Study Locations
-
-
Ontario
-
St. Catharines, Ontario, Canada, L2S 3A1
- Brock University
-
Contact:
- Brian D Roy, PhD
- Phone Number: 3779 905-688-5550
- Email: broy@brocku.ca
-
Principal Investigator:
- Brian D Roy, PhD
-
Sub-Investigator:
- Wendy Ward, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 28 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Alternate Intake-time
|
3 additional servings of low fat dairy will be consumed
Maltodextrin will be provided in an amount equal to the the energy content in the 3 supplemental servings of low-fat dairy.
|
Experimental: Immediately post-exercise
|
3 additional servings of low fat dairy will be consumed
Maltodextrin will be provided in an amount equal to the the energy content in the 3 supplemental servings of low-fat dairy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body composition
Time Frame: 12 weeks
|
12 weeks
|
Bone mineral density
Time Frame: 12 weeks
|
12 weeks
|
VO2 peak
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
mitochondrial enzyme activity
Time Frame: 12 weeks
|
12 weeks
|
muscle oxidative stress
Time Frame: 12 weeks
|
12 weeks
|
muscle capillary density
Time Frame: 12 weeks
|
12 weeks
|
blood lipids
Time Frame: 12 weeks
|
12 weeks
|
blood inflammatory markers
Time Frame: 12 weeks
|
12 weeks
|
blood markers of bone turnover
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brian D Roy, PhD, Brock University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Anticipated)
December 1, 2012
Study Completion (Anticipated)
February 1, 2013
Study Registration Dates
First Submitted
March 12, 2012
First Submitted That Met QC Criteria
March 13, 2012
First Posted (Estimate)
March 14, 2012
Study Record Updates
Last Update Posted (Estimate)
March 14, 2012
Last Update Submitted That Met QC Criteria
March 13, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BUCT-11-221
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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