NCT01553370

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2012

Completed
18 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

March 14, 2012

Status Verified

March 1, 2012

Enrollment Period

8 months

First QC Date

March 12, 2012

Last Update Submit

March 13, 2012

Conditions

Overweight

Outcome Measures

Primary Outcomes (3)

  • Body composition

    12 weeks

  • Bone mineral density

    12 weeks

  • VO2 peak

    12 weeks

Secondary Outcomes (6)

  • mitochondrial enzyme activity

    12 weeks

  • muscle oxidative stress

    12 weeks

  • muscle capillary density

    12 weeks

  • blood lipids

    12 weeks

  • blood inflammatory markers

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Alternate Intake-time

ACTIVE COMPARATOR
Other: Increased Dairy IntakeOther: Supplemental carbohydrate

Immediately post-exercise

EXPERIMENTAL
Other: Increased Dairy IntakeOther: Supplemental carbohydrate

Interventions

Increased Dairy IntakeOTHER

3 additional servings of low fat dairy will be consumed

Alternate Intake-timeImmediately post-exercise
Supplemental carbohydrateOTHER

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

Alternate Intake-timeImmediately post-exercise

Eligibility Criteria

Age18 Years - 28 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI greater or equal to 25
  • healthy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brock University

St. Catharines, Ontario, L2S 3A1, Canada

Location

Related Links

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Brian D Roy, PhD

    Brock University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian D Roy, PhD

CONTACT

905-688-5550broy@brocku.ca

Wendy Ward, PhD

CONTACT

905-688-5550wward@brocku.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 12, 2012

First Posted

March 14, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2012

Study Completion

February 1, 2013

Last Updated

March 14, 2012

Record last verified: 2012-03

Locations

CA(1)