Effect of Calcium + Vitamin D Supplementation on Weight Management in Very-low Calcium Consumers

A Randomized, Open-label, Parallel Groups-controlled Clinical Trial to Evaluate the Effect of Calcium Plus Vitamin D Supplementation on Weight Management in Overweight and Obese Very-low Calcium Consumers

The purpose of the study is to determine whether calcium plus vitamin D supplementation is conducive to weight and fat loss during energy restriction in very-low calcium consumers.

Due to the contradicting findings in the hypothesis of calcium supplementation on weight and fat loss, which might be explained by the difference in initial calcium intake, the present study is aimed to evaluate the effect of calcium plus vitamin D supplementation on accelerating weight and fat loss in overweight or obese subjects with very-low calcium consumption(<600mg/day).

The hypotheses to be tested are:

Calcium plus vitamin D supplementation is conducive to body weight and fat loss in overweight or obese young adults during energy restriction 12 weeks after randomization.

Inclusion Criteria:

• Male or female 18 to 25 years of age, generally healthy
• Habitual calcium intake below 600mg/d
• Overweight or obese (BMI between 24 and 35kg/m2, refer to the Chinese standard)
• Stable body weight (body weight change less than 1kg two months before screening)
• Less than 3 times of 20min of physical exercise per week
• Signed written informed consent

Exclusion Criteria:

• Coronary heart disease, hypertension, diabetes; hepatic insufficiency or renal insufficiency, hyper- or hypothyroidism, mal-absorption, cholesterol concentrations requiring pharmaceutical treatment
• Pregnant or lactating woman
• Use of calcium supplements, oral antidiabetic agents, antihyperlipidemics or any other medications affecting metabolism 30 days before randomization
• Participating in another weight loss programs (i.e. taking oral pharmacotherapeutic agents and/or herbal preparations intended for the management of obesity; excessive physical activity; be on a diet)
• On special diets (i.e. vegetarian)
• Presently taking or have recently taken a prescription drug such as fluoroquinolone antibiotics, tetracycline, or levothyroxine (thyroid medication)
• Participating in another clinical trial 6 months before randomization
• Unlikely to be compliant (i.e. alcohol, drug abuse)
• Refusal or inability to give informed consent to participate in the study