Milk Supplementation and Energy Balance. | NCT00729170

Studies
Milk Supplementation and Energy Balance.

NCT00729170

Sponsor

Laval University

Status

Completed

Last Update Posted

Jul 2, 2012Estimated

Enrollment

41Actual

Phase

Not Applicable

Conditions

Obesity
Osteoporosis

Interventions

Supplementation of milk (35% more calcium)

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

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Sep 2008Actual

Completion Date

Feb 2009Actual

First Submitted Date

Aug 5, 2008

First Submission Date that Met QC Criteria

Aug 6, 2008

First Posted Date

Aug 7, 2008Estimated

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

Jun 29, 2012

Last Update Posted Date

Jul 2, 2012Estimated

Name	Class
Dairy Farmers of Canada	OTHER
National Dairy Council	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The aim of the project is to determine if milk supplementation during a caloric restriction program facilitates the lost of weight, improves the appetite control and attenuates the decrease of bone mineral content in low-calcium consumer women.

Detailed Description

Calcium deficiency is related to a higher risk of obesity. Some studies showed a lost of weight by elevating the calcium consumption to reach the recommended level. Milk supplementation could be a good alternative to reach this objective, but its impact on weight loss and on appetite sensations has not been verified. Furthermore, losing weight leads to some negative consequences like a decrease of bone mineral content. Considering the benefits of milk on bone health, a higher intake of this food product during weight loss could represent a healthy strategy.

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

41Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Supplementation of milk (35% more calcium)	Dietary Supplement	The supplement provides 1000 mg of calcium and 250 kcal daily.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Body composition (body weight, fat mass, anthropometric measurements)		Baseline, month 1, and month 6

Secondary Outcomes

Measure	Description	Time Frame
Bone density (DXA)		Baseline and month 6
Appetite sensations		Baseline, month 1, and month 6

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Low-calcium consumer (less than 800 mg daily)
BMI between 27 to 42 kg/m2
Sedentary
Healthy

Exclusion Criteria:

In menopause
Medications that alter the project's objectives
Smoker
Dietary supplement consumer
High alcohol or caffeine consumer

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Angelo Tremblay, Ph.D.	Laval University	Principal Investigator
Denis R Joanisse, Ph.D.	Laval University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre de recherche de l'Hôpital Laval		Québec	Quebec	G1V 4G5	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21205360	Derived	Gilbert JA, Joanisse DR, Chaput JP, Miegueu P, Cianflone K, Almeras N, Tremblay A. Milk supplementation facilitates appetite control in obese women during weight loss: a randomised, single-blind, placebo-controlled trial. Br J Nutr. 2011 Jan;105(1):133-43. doi: 10.1017/S0007114510003119.

ID	Term
D009765	Obesity
D010024	Osteoporosis
D015431	Weight Loss

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases