Effects of Protein-Enriched Meal on Liver, Kidney or Bone: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The primary efficacy endpoint is the change in weight.
研究概览
简要总结
This study will examine whether a higher protein meal replacement diet (consisting of 1 gram of protein per pound lean body mass) is more effective in causing weight loss compared to a standard meal replacement protein diet (consisting of ½ gram of protein per pound of lean body mass). The study will assign approximately 100 subjects (50 each) to the following arms 1) higher meal replacement diet program 2) standard meal replacement diet program. All participants will meet with a registered dietitian to provide nutrition education and behavior modification, including general exercise recommendations. As part of your participation, you must be willing to undergo a measurement of body fat, and blood tests, and be willing to use Herbalife Meal replacements as part of your diet for the duration of the study (one year).
详细描述
There is concern that excess protein intake may be damaging to liver, renal function, and bone health. This study was designed to compare the effects of a high protein (HP) and an isocaloric meal standard protein (SP) weight loss plan on liver function, renal function and bone metabolism.
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, Investigator)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 30 years and older at screening
- •Female subjects must have a negative pregnancy test at screening, must be surgically sterile or at least 6 months postmenopausal or must use a form of birth control measure. Hormonal birth control, IUD, or abstinence will be acceptable as birth control measures. Other types of birth controls such as condom, diaphragm, or sponges may not be considered adequate forms of birth control measures in this study.
- •BMI of 27 to 40 kg/m2 inclusive.
- •Subjects must be in good health as determined by medical history, physical examination, and screening clinical laboratory including chemistry panel and CBC.
- •h. Must have stable smoking habits (or be non-smokers) for at least 6 months prior to screening and agree not to intend to change such habits during the course of the study.
- •i. Subjects requiring the regular use of any prescription medication may be admitted to the study providing the dose is stable.
- •Subject must sign the Institutional Review Board-approved written informed consent prior to he initiation of any study specific procedures or randomization. A subject will be excluded for any condition that might compromise the ability to give truly informed consent for participation in the study.
排除标准
- •Weight Stability. Any subject who reports weight change of > 3.0 kg in the month prior to screening.
- •Any subject who has been on a very low calorie diet ( < 800 kcal/day) for a period of 4 months or more in the 12 months prior to screening, or who has lost > 10 kg in the 6 months prior to screening.
- •Use of any other investigational drug (s) within 8 weeks prior to screening.
- •Abnormal laboratory parameters: Serum creatinine > 1.6 mg/dl, Liver function tests, ALT, AST, Bili results > 2.0 times the upper limit of normal. Triglycerides > 500 mg/dl, total cholesterol > 350 mg/dl, TSH outside of normal range.
- •Subjects who drink more than 1 alcoholic beverages per day.
结局指标
主要结局
The primary efficacy endpoint is the change in weight.
时间窗: Baseline, 3, 6 and 12 months
次要结局
- Secondary endpoints are changes in fasting plasma glucose levels associated with weight loss, insulin, blood pressure, lipid levels and body fat.(Baseline and 12 months)