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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2005-07-31

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.

Conditions

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Obesity Overweight

Keywords

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Caltrate Lipoproteins Glucose Insulin Blood pressure Body fat Body weight Women Diet Macronutrients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Caltrate® 600 + D

Intervention Type DRUG

Weight loss intervention

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Angelo Tremblay, PhD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

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Université Laval

Québec, Quebec, Canada

Site Status

Countries

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Canada

References

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Major GC, Alarie FP, Dore J, Tremblay A. Calcium plus vitamin D supplementation and fat mass loss in female very low-calcium consumers: potential link with a calcium-specific appetite control. Br J Nutr. 2009 Mar;101(5):659-63. doi: 10.1017/s0007114508030808.

Reference Type DERIVED

PMID: 19263591 (View on PubMed)

Other Identifiers

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CL-02-01

Identifier Type: -

Identifier Source: org_study_id