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Milk Supplementation and Energy Balance.

This study has been completed.
Sponsor:
Collaborators:
Dairy Farmers of Canada
National Dairy Council
Information provided by (Responsible Party):
Angelo Tremblay, Laval University
ClinicalTrials.gov Identifier:
NCT00729170
First received: August 5, 2008
Last updated: June 29, 2012
Last verified: June 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 Laval University:

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

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

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

Ages Eligible for Study:   25 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Laval University

Additional 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
Study First Received: August 5, 2008
Last Updated: June 29, 2012
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on November 25, 2014