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

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.

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.

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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