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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
Brock University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight

Eligibility Criteria

18 Years - 28 Years (Adult)MaleAccepts Healthy Volunteers

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

First Posted
March 12, 2012
Last Updated
March 13, 2012
Sponsor
Brock University
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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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