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Completed

NCT Number: NCT00729170

Milk Supplementation and Energy Balance.

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Osteoporosis Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

25 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre de recherche de l'Hôpital Laval

Québec, Quebec, G1V 4G5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supplementation of milk (35% more calcium)

Dietary Supplement

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

Primary outcomes

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

    Time frame: Baseline, month 1, and month 6

Secondary outcomes

  1. Bone density (DXA)

    Time frame: Baseline and month 6

  2. Appetite sensations

    Time frame: Baseline, month 1, and month 6

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Dairy Farmers of Canada
  • National Dairy Council

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Aug 7, 2008
Registry last updated
Jul 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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