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

• Change in Body Fat Mass，Body Lean Mass and Visceral Fat Mass [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  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 [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine fat percentage.
• Change in Visceral Fat Area [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine visceral fat area.
• Change in Waist, Abdominal and Hip Circumference [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  Waist, abdominal and hip circumference was measured using a plastic tape to the nearest 0.1 cm
• Change in Blood Pressure [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  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 [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
• Change in Fasting Plasma Glucose [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
• Change in Fasting Plasma Insulin [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
• Change in Energy Intakes [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

• Change in body fat [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  including changes in total body fat and visceral fat
• Changes in anthropometric values [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  including waist circumference, abdominal circumference and hipline
• Changes in metabolic profile [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  including fasting triglyceride, cholesterol, HDL, LDL, blood glucose and insulin, as well as blood pressure

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.

• Obesity
• Overweight

• Drug: Calcium Carbonate
  tablet, 600mg elemental calcium and 125IU vitamin D, once daily, for 12 weeks
  Other Names:

  • Caltrate® 600 + D
  • Code:1007300
• Behavioral: Energy restriction
  A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.

• Experimental: Calcium+D
  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.
  Interventions:

  • Drug: Calcium Carbonate
  • Behavioral: Energy restriction
• Placebo Comparator: Control
  A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
  Intervention: Behavioral: Energy restriction

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