Substituting Mushrooms for Meat: A Controlled Clinical Trial to Control Body Weight
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Weight-control efficacy
研究概览
简要总结
This is a one-year clinical trial to assess weight-loss, weight-maintenance, and biochemical parameters following a weight-control diet using either standard food guide pyramid alone, or standard food guide pyramid with substitution of mushrooms for meat.
详细描述
This intervention study has a primary aim to assess omnivorous adult males and females' ability to control their weight over a period of 1 year. The control group will be required to use 90% lean ground beef a few times per week for one year while maintaining their personalized diet plans. The experimental group will have to follow their personalized diets as well, but will be required to substitute mushrooms for meat at least three times per week. Biochemical measures will also be assessed in response to the diet and weight 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male, female, >=18 years old
- •Omnivorous
- •BMI 25-40
- •Seeking weight-loss
排除标准
- •<18 years old
- •Vegetarians
- •Dislike mushroom
- •Chronic disease
- •Rheumatoid arthritis
- •Pregnant or nursing child
- •Must not self-report allergies to mushrooms
研究组 & 干预措施
Mushroom
Mushroom enriched weight loss diet. Participants will be given a personalized diet plan, at a calorie level sufficiently restricted to result in a 20 lb weight loss over a period of 6 months, followed by a weight maintenance diet for a further 6 months.
干预措施: Weight-loss and weight-maintenance diets (Behavioral)
No mushroom diet
Participants will be given a personalized diet plan, without use of mushrooms as part of the diet, at a calorie level sufficiently restricted to result in a 20 lb weight loss over a period of 6 months, followed by a weight maintenance diet for a further 6 months.
干预措施: Weight-loss and weight-maintenance diets (Behavioral)
结局指标
主要结局
Weight-control efficacy
时间窗: 1 year
Weight-loss efficacy
时间窗: 6 months
次要结局
- Effect of mushroom-substituted meals on biomarkers for oxidative stress, immune function and inflammation(6 months)