Milk Supplementation and Energy Balance.

June 29, 2012 updated by: Angelo Tremblay, Laval University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1V 4G5
        • Centre de recherche de l'Hopital Laval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Collaborators

Dairy Farmers of Canada
National Dairy Council

Investigators

  • Principal Investigator: Angelo Tremblay, Ph.D., Laval University
  • Principal Investigator: Denis R Joanisse, Ph.D., Laval University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

August 5, 2008

First Submitted That Met QC Criteria

August 6, 2008

First Posted (Estimate)

August 7, 2008

Study Record Updates

Last Update Posted (Estimate)

July 2, 2012

Last Update Submitted That Met QC Criteria

June 29, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1_Tremblay

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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