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Milk Supplementation and Energy Balance.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00729170
First Posted: August 7, 2008
Last Update Posted: July 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Dairy Farmers of Canada
National Dairy Council
Information provided by (Responsible Party):
Angelo Tremblay, Laval University
  Purpose
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.

Condition Intervention
Obesity Osteoporosis Dietary Supplement: Supplementation of milk (35% more calcium)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Impact of Milk Supplementation on Body Composition, Bone Density and Satiety in Women Following a Weight Loss Program.

Resource links provided by NLM:


Further study details as provided by Angelo Tremblay, Laval University:

Primary Outcome Measures:
  • Body composition (body weight, fat mass, anthropometric measurements) [ Time Frame: Baseline, month 1, and month 6 ]

Secondary Outcome Measures:
  • Bone density (DXA) [ Time Frame: Baseline and month 6 ]
  • Appetite sensations [ Time Frame: Baseline, month 1, and month 6 ]

Enrollment: 41
Study Start Date: October 2006
Study Completion Date: February 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Supplementation of milk (35% more calcium)
    The supplement provides 1000 mg of calcium and 250 kcal daily.
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00729170


Locations
Canada, Quebec
Centre de recherche de l'Hôpital Laval
Québec, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Laval University
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Angelo Tremblay, Professor, Laval University
ClinicalTrials.gov Identifier: NCT00729170     History of Changes
Other Study ID Numbers: 1_Tremblay
First Submitted: August 5, 2008
First Posted: August 7, 2008
Last Update Posted: July 2, 2012
Last Verified: June 2012

Keywords provided by Angelo Tremblay, Laval University:
Milk
Calcium
Weight loss
Bone density
Appetite

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs