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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Change in Body Weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Calcium Carbonate (Drug)
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.
干预措施: Energy restriction (Behavioral)
Control
A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
干预措施: Energy restriction (Behavioral)
结局指标
主要结局
Change in Body Weight
时间窗: 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.
次要结局
- Change in Fat Percentage(Baseline and 12 weeks)
- Change in Body Fat Mass，Body Lean Mass and Visceral Fat Mass(Baseline and 12 weeks)
- Change in Visceral Fat Area(Baseline and 12 weeks)
- Change in Waist, Abdominal and Hip Circumference(Baseline and 12 weeks)
- Change in Blood Pressure(Baseline and 12 weeks)
- 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)