Muscle-Sparing Effect Of Human Chorionic Gonadotropin (hCG) During a Very Low Calorie Diet (VLCD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Weight loss achieved during a trial of HCG vs. Placebo and a very low calorie diet.
研究概览
简要总结
Subjects are female patients, randomized to HCG group or placebo group, during a prospective trial, in order to determine the significance, if any, of HCG on maintaining muscle mass during a very low calorie diet in order to demonstrate the potential significance of HCG administration on preserving lean body mass while losing weight.
详细描述
Four-week clinical trials were conducted on 59 females between the ages of 20 and 55, over an 18 month period. Exclusion criteria included thyroid conditions or prior significant medical history. Patients were randomized to receive daily subcutaneous injections of either hCG (200-300IU) or saline (placebo). All were placed on a VLCD resembling a protein-sparing modified fast. The caloric intake was between 500 and 600 calories, with 50% protein and 50% complex carbohydrates consisting mostly of fruits and vegetables. Measured parameters: weight, body composition via bio-impedance, blood pressure, and blood labs. A subset also underwent weekly electrocardiograms (EKG).
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 (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) greater than 30,
- •good health
排除标准
- •complex medical history,
- •thyroid disease,
- •BMI less than 30,
- •psychological instability or history of eating disorder
研究组 & 干预措施
Saline/Placebo
This group received daily subcutaneous injections of saline while eating a very low calorie diet of 500 calories per day.
干预措施: Low calorie diet (Other)
HCG Group
This group received daily subcutaneous injections of Human Chorionic Gonadotropin while eating a very low calorie diet of 500 calories per day.
干预措施: Human Chorionic Gonadotropin (Drug)
HCG Group
This group received daily subcutaneous injections of Human Chorionic Gonadotropin while eating a very low calorie diet of 500 calories per day.
干预措施: Low calorie diet (Other)
Saline/Placebo
This group received daily subcutaneous injections of saline while eating a very low calorie diet of 500 calories per day.
干预措施: Placebo (Drug)
结局指标
主要结局
Weight loss achieved during a trial of HCG vs. Placebo and a very low calorie diet.
时间窗: 30 days
Comparison of weight loss between the experimental and control group
次要结局
- Muscle loss comparison between HCG and placebo group during a very low calorie diet.(30 days)