Milk Supplementation and Energy Balance.
This study has been completed.
Sponsor:
Laval University
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 5, 2008 | ||||||||
| Last Updated Date | June 29, 2012 | ||||||||
| Start Date ICMJE | October 2006 | ||||||||
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Body composition (body weight, fat mass, anthropometric measurements) [ Time Frame: Baseline, month 1, and month 6 ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00729170 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Milk Supplementation and Energy Balance. | ||||||||
| Official Title ICMJE | Impact of Milk Supplementation on Body Composition, Bone Density and Satiety in Women Following a Weight Loss Program. | ||||||||
| Brief Summary | 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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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Dietary Supplement: Supplementation of milk (35% more calcium)
The supplement provides 1000 mg of calcium and 250 kcal daily. |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Gilbert JA, Joanisse DR, Chaput JP, Miegueu P, Cianflone K, Alméras N, Tremblay A. Milk supplementation facilitates appetite control in obese women during weight loss: a randomised, single-blind, placebo-controlled trial. Br J Nutr. 2011 Jan;105(1):133-43. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 41 | ||||||||
| Completion Date | February 2009 | ||||||||
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 25 Years to 50 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00729170 | ||||||||
| Other Study ID Numbers ICMJE | 1_Tremblay | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Angelo Tremblay, Laval University | ||||||||
| Study Sponsor ICMJE | Laval University | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Laval University | ||||||||
| Verification Date | June 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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