Randomized Controlled Trial of Milk Products and Physical... | NCT01553370

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

NCT01553370

Sponsor

Brock University

Status

Unknown status

Last Update Posted

Mar 14, 2012Estimated

Enrollment

54Estimated

Phase

Not Applicable

Conditions

Overweight

Interventions

Increased Dairy Intake
Supplemental carbohydrate

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Dec 2012Estimated

Completion Date

Feb 2013Estimated

First Submitted Date

Mar 12, 2012

First Submission Date that Met QC Criteria

Mar 13, 2012

First Posted Date

Mar 14, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2012

Last Update Posted Date

Mar 14, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

54Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Alternate Intake-time	Active Comparator		Other: Increased Dairy Intake Other: Supplemental carbohydrate
Immediately post-exercise	Experimental		Other: Increased Dairy Intake Other: Supplemental carbohydrate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Increased Dairy Intake	Other	3 additional servings of low fat dairy will be consumed	Alternate Intake-time Immediately post-exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Body composition		12 weeks
Bone mineral density		12 weeks
VO2 peak		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
mitochondrial enzyme activity		12 weeks
muscle oxidative stress		12 weeks
muscle capillary density

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

28 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Brian D Roy, PhD	Contact	905-688-5550	3779	broy@brocku.ca
Wendy Ward, PhD	Contact	905-688-5550	3024	wward@brocku.ca

Overall Officials

Name	Affiliation	Role
Brian D Roy, PhD	Brock University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brock University		St. Catharines	Ontario	L2S 3A1	Canada

References Module

Citations

Not provided

Label	URL
University website	View source
Sponsor of the trial	View source

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight