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

Phase 4

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Calcium+D	Calcium Carbonate	Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
Calcium+D	Energy restriction	Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
Control	Energy restriction	A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.

Primary Outcome Measures

Name	Time	Method
Change in Body Weight	Baseline and 12 weeks	Weight was obtained in light clothing to the nearest 0.1kg using a digital scale 8:00am and 10:00am after an overnight fast between.

Secondary Outcome Measures

Name	Time	Method
Change in Body Fat Mass，Body Lean Mass and Visceral Fat Mass	Baseline and 12 weeks	BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine body fat mass, body lean mass, and visceral fat mass.
Change in Fat Percentage	Baseline and 12 weeks	BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine fat percentage.
Change in Visceral Fat Area	Baseline and 12 weeks	BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine visceral fat area.
Change in Waist, Abdominal and Hip Circumference	Baseline and 12 weeks	Waist, abdominal and hip circumference was measured using a plastic tape to the nearest 0.1 cm
Change in Blood Pressure	Baseline and 12 weeks	Systolic and diastolic blood pressures were measured in the left arm at heart level of subjects seated for a minimum of 5 minutes using mercurial sphygmomanometer.
Change in Lipid-lipoprotein Profile	Baseline and 12 weeks
Change in Fasting Plasma Glucose	Baseline and 12 weeks
Change in Fasting Plasma Insulin	Baseline and 12 weeks
Change in Energy Intakes	Baseline and 12 weeks