The Effect of Incorporating Soy Protein Foods in the Colorado Diet for Weight Loss and Maintenance.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Change from baseline in body fat at the end of a 52 week period
研究概览
简要总结
Dietary protein is a key element of most effective weight loss regimens. This study will investigate the effects of consuming soy protein on body composition and cardiometabolic health within the context of an effective weight loss and maintenance program called the Colorado Diet.
详细描述
This is a randomized study involving 60 study subjects (30 per arm). Investigators plan to enroll 72 subjects (36 per arm) in order to allow for any potential drop outs with the goal of 60 study completers. Investigators will compare the efficacy of inducing weight loss of two treatment arms all based on the Colorado Diet. Subjects will be randomly assigned to one of two study arms and instructed to follow the Colorado Diet by participating in weekly Colorado Diet group classes (State of Slim class). There will be 4 classes of 18 subjects each (two classes for each treatment group). Subjects will be followed in the study for 12 months. Subjects will be randomized into one of two treatment groups as follows:
- Group 1 will participate in a State of Slim group class, receive a State of Slim book (describing the Colorado Diet), and will then purchase food items allowed in the Colorado Diet from the lists of acceptable foods in the State of Slim book.
- Group 2 will participate in a State of Slim class, receive the State of Slim book, and be provided soy protein foods to be consumed as part of the Colorado Diet (subjects will receive up to 3 foods with approximately 20g of soy protein each, per day).
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females ages 18 - 55 years
- •BMI between 27-40
- •Weight stable (have not lost or gained more than 10 pounds in the last 3 months)
- •Generally healthy
- •Able to exercise 70 minutes per day at moderate intensity
- •Willing and able to participate in a State of Slim group class for the first 16 weeks of the study and willing to participate in 5 study visits over the 12 month study period.
排除标准
- •Pregnant or trying to become pregnant.
- •Diagnosis of type 1 or type 2 diabetes
- •Individuals following a vegetarian only diet
- •Food allergies (to soy, dairy, wheat/gluten, eggs, or peanuts)
- •Taking medications that could cause weight loss or weight gain or alter plasma lipids (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or over-the-counter weight loss agents, statins, fibrates, niacin, etc). Oral contraceptives can be used as long as subject agrees to not change use of these during the study. Multivitamins containing niacin can be used as long as subject agrees to not change use of these during the study.
- •Known renal disease
- •hypothyroidism
- •Current alcohol or drug abuse or dependence (Subjects who have quit smoking in the last 6 months will be excluded. Smokers whose smoking habits have been stable for the last 6 months and which remain stable during the study can be included).
- •Any medical condition for which following a diet and/or 70 minutes of exercise daily would be inadvisable
- •LDL cholesterol levels above 190 mg/dl or triglycerides above 400 mg/dl.
研究组 & 干预措施
Soy Group
Subjects in the soy group were asked to participate in the Colorado Diet program and to consume 3 soy food items per day.
干预措施: Soy group (Behavioral)
Non-soy Group
Subjects in the non-soy group were asked to participate in the Colorado Diet program and to avoid soy food products.
干预措施: Non-soy group (Behavioral)
结局指标
主要结局
Change from baseline in body fat at the end of a 52 week period
时间窗: at month 12
Change from baseline in lipid panel results at end of 16 week period (triglycerides)
时间窗: at month 4
Change from baseline in lipid panel results at end of 52 week period (triglycerides)
时间窗: at month 12
Change from baseline in lipid panel results at end of 16 week period (total cholesterol)
时间窗: at month 4
Change from baseline in lipid panel results at end of 52 week period (total cholesterol)
时间窗: at month 12
Change from baseline in lipid panel results at end of 16 week period (LDL)
时间窗: at month 4
Change from baseline in lipid panel results at end of 52 week period (LDLl)
时间窗: at month 12
Change from baseline in lipid panel results at end of 16 week period (HDL)
时间窗: at month 4
Change from baseline in lipid panel results at end of 52 week period (HDL)
时间窗: at month 12
Change from baseline in % body weight at the end of a 16 week period
时间窗: at month 4
Change from baseline in body fat at the end of 16 week period
时间窗: at month 4
Change from baseline in % body weight at the end of a 52 week period
时间窗: at month 12
次要结局
未报告次要终点