NCT00353054已完成4 期
A Double-Blind, Randomized, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Calcium/Vitamin D Supplementation (Caltrate 600+ D) on Body Weight and Fat Loss in Overweight and Obese Individuals on a Weight-Reducing Program.
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Body weight and fat mass loss at the end of the 15-week weight loss supplemented intervention.
研究概览
简要总结
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
详细描述
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.
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
- Double
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Breast feeding, pregnant or menopaused women
- •Use of calcium supplements within 30 days of screening
- •Cholesterol levels requiring pharmaceutical treatment
- •Use of medication that could affect body weight
结局指标
主要结局
Body weight and fat mass loss at the end of the 15-week weight loss supplemented intervention.
次要结局
- Change in metabolic variables at the end of the 15-week calcium/vitamin D supplemented weight loss intervention
- Change in energy/macronutrient intake at the end of the 15-week calcium/vitamin D supplemented weight loss intervention
研究者
研究点 (2)
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