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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
History of Changes
  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:

U.S. FDA Resources

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
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. Université Laval
Principal Investigator: Denis R Joanisse, Ph.D. Université Laval
  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:
Obesity
Osteoporosis
Overnutrition
Nutrition Disorders
Overweight
 Body Weight
Signs and Symptoms
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 16, 2013