- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00353054
Effect of Calcium/Vitamin D Supplementation on Body Weight and Fat Loss.
A Double-Blind, Randomized, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Calcium/Vitamin D Supplementation (Caltrate 600+ D) on Body Weight and Fat Loss in Overweight and Obese Individuals on a Weight-Reducing Program.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The effect of a calcium supplementation on body weight loss is inconclusive and some studies have suggested that adequate calcium intake can have a favourable effect on some metabolic variables. The objectives of this study were to evaluate the impact of (Caltrate 600 + D ®) on body composition and various indicators of metabolic health in overweight and obese females characterised by a usual low daily calcium intake, on a weight-reducing program.
The main hypotheses of this study were:
- Caltrate 600 +D® increases body weight and fat mass losses of individuals on a weight-reducing program.
- Caltrate 600 +D® improves the metabolic profile of these subjects, independently of variations promoted by body fat loss.
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Quebec, Canada, G1K 7P4
- Universite Laval
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Daily calcium intake below 800mg/day
- Stable body weight
- Body mass index (BMI) between 27-40kg/m2
- Less than 3 periods of 20 minutes of physical exercise/week
- General good health
- Normal blood pressure values
- Normal cholesterol levels
- Normal thyroid hormone levels
- No participation in another clinical trial within 6 months of screening
- Coffee consumption ≤ 5 cups/day.
Exclusion Criteria:
- Breast feeding, pregnant or menopaused women
- Use of calcium supplements within 30 days of screening
- Cholesterol levels requiring pharmaceutical treatment
- Smoking
- Use of medication that could affect body weight
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Body weight and fat mass loss at the end of the 15-week weight loss supplemented intervention.
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Secondary Outcome Measures
Outcome Measure |
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Change in metabolic variables at the end of the 15-week calcium/vitamin D supplemented weight loss intervention
|
Change in energy/macronutrient intake at the end of the 15-week calcium/vitamin D supplemented weight loss intervention
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Angelo Tremblay, PhD, Laval University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CL-02-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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