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Milk Supplementation and Energy Balance.

Primary Purpose

Obesity, Osteoporosis

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Supplementation of milk (35% more calcium)

About this trial

This is an interventional treatment trial for Obesity focused on measuring Milk, Calcium, Weight loss, Bone density, Appetite

Eligibility Criteria

25 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Centre de recherche de l'Hôpital Laval

Outcomes

Primary Outcome Measures

Body composition (body weight, fat mass, anthropometric measurements)

Secondary Outcome Measures

Bone density (DXA)

Appetite sensations

Full Information

NCT ID

NCT00729170

First Posted

August 5, 2008

Last Updated

June 29, 2012

Sponsor

Laval University

Collaborators

Dairy Farmers of Canada, National Dairy Council

1. Study Identification

Unique Protocol Identification Number

NCT00729170

Brief Title

Milk Supplementation and Energy Balance.

Official Title

Impact of Milk Supplementation on Body Composition, Bone Density and Satiety in Women Following a Weight Loss Program.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Laval University

Collaborators

Dairy Farmers of Canada, National Dairy Council

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Osteoporosis

Keywords

Milk, Calcium, Weight loss, Bone density, Appetite

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Dietary Supplement

Intervention Name(s)

Supplementation of milk (35% more calcium)

Intervention Description

The supplement provides 1000 mg of calcium and 250 kcal daily.

Primary Outcome Measure Information:

Title

Body composition (body weight, fat mass, anthropometric measurements)

Time Frame

Baseline, month 1, and month 6

Secondary Outcome Measure Information:

Title

Bone density (DXA)

Time Frame

Baseline and month 6

Title

Appetite sensations

Time Frame

Baseline, month 1, and month 6

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Angelo Tremblay, Ph.D.

Organizational Affiliation

Laval University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Denis R Joanisse, Ph.D.

Organizational Affiliation

Laval University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre de recherche de l'Hôpital Laval

City

Québec

State/Province

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

21205360

Citation

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.

Results Reference

derived

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Milk Supplementation and Energy Balance.

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