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
- 72
- 试验地点
- 2
- 主要终点
- Body weight & body composition
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 comparing 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 State of Slim group classes. Subjects will be followed in the study for one year. The Colorado Diet consists of 3 phases: phase 1 (week 1-2), phase 2 (weeks 3 - 8), and phase 3 (weeks 9 - 16). The maintenance phase lasts from months 5 - 12. Body weight will be monitored at each study visit and body composition will be determined using DXA. Blood lipid and lipoprotein concentrations, health & wellness questionnaires, and fitness measures will also be assessed throughout the study.
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
- •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, or peanut)
- •Taking medications that could cause weight loss or weight gain or alter plasma lipids (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or OTC 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.
- •Known renal disease
- •Clinical 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
Colorado Diet with soy protein
干预措施: Colorado Diet with soy protein foods. (Dietary Supplement)
Colorado Diet
干预措施: Colorado Diet with monetary payments (Behavioral)
结局指标
主要结局
Body weight & body composition
时间窗: 0, 2, 4, 8, 12 mths
Changes in skeletal muscle mass and fat mass will be measured using dual-energy X-ray absorptiometry (DXA)
次要结局
- Blood lipid and lipoproteins(0, 2, 4, 8, 12 mths)
- Level of Fitness(0, 12 mths)
- Quality of Life(0, 4, 8, 12 mths)
- C-reactive protein(0, 2, 4, 8, 12 mths)