Effect of Calcium/Vitamin D Supplementation on Body Weight and Fat Loss.

Study Overview
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Brief Summary
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The aim of this study was to assess the effect of calcium/vitamin D supplementation (Caltrate 600 +D®) on body weight loss during a weight-reducing program

Detailed Description
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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.

Official Title
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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.

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Drug: Caltrate® 600 + D
* Behavioral: Weight loss intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Caltrate® 600 + D|nan|
|Behavioral: Weight loss intervention|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight and fat mass loss at the end of the 15-week weight loss supplemented intervention. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caltrate, Lipoproteins, Glucose, Insulin, Blood pressure, Body fat, Body weight, Women, Diet, Macronutrients