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

NCT ID: NCT01553370

Last Updated: 2012-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Alternate Intake-time

Group Type ACTIVE_COMPARATOR

Increased Dairy Intake

Intervention Type OTHER

3 additional servings of low fat dairy will be consumed

Supplemental carbohydrate

Intervention Type OTHER

Maltodextrin will be provided in an amount equal to the the energy content in the 3 supplemental servings of low-fat dairy.

Immediately post-exercise

Group Type EXPERIMENTAL

Increased Dairy Intake

Intervention Type OTHER

3 additional servings of low fat dairy will be consumed

Supplemental carbohydrate

Intervention Type OTHER

Maltodextrin will be provided in an amount equal to the the energy content in the 3 supplemental servings of low-fat dairy.

Interventions

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Increased Dairy Intake

3 additional servings of low fat dairy will be consumed

Intervention Type OTHER

Supplemental carbohydrate

Maltodextrin will be provided in an amount equal to the the energy content in the 3 supplemental servings of low-fat dairy.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

28 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Brock University

OTHER

Sponsor Role lead

Responsible Party

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Brian Roy

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brian D Roy, PhD

Role: PRINCIPAL_INVESTIGATOR

Brock University

Locations

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Brock University

St. Catharines, Ontario, Canada

Site Status

Countries

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Canada

Central Contacts

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Brian D Roy, PhD

Role: CONTACT

905-688-5550 ext. 3779

Wendy Ward, PhD

Role: CONTACT

905-688-5550 ext. 3024

Facility Contacts

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Brian D Roy, PhD

Role: primary

905-688-5550 ext. 3779

Related Links

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http://www.brocku.ca

University website

http://www.dairyfarmers.ca/

Sponsor of the trial

Other Identifiers

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BUCT-11-221

Identifier Type: -

Identifier Source: org_study_id

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