Legume Diet Satiety and Weight Loss Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Change in Weight
研究概览
简要总结
This pilot study is designed to test the effects of a high legume (dried bean) diet on hunger and other indicators of health over the course of eight weeks, compared to a more conventional healthy diet.
详细描述
The goal of the currently proposed study is to conduct a randomized controlled feeding pilot study within a more diverse population also at high risk for colorectal carcinoma (CRC) to evaluate whether a high-legume diet will result in increased satiety and in turn will facilitate reduced energy intake and weight loss compared to a control diet provided under similar conditions. In addition, explore potential beneficial effects of the high-legume diet on gastric emptying and circulating levels of appetite-regulating hormones and other biomarkers. Dietary behaviors that are even moderately more satiating over time have the potential to enhance weight loss and could lead to a significant public health impact among populations at high risk for colorectal carcinoma (CRC) and other chronic diseases.
Towards the end of the study, the participants will do an additional test, looking at how long food takes to pass through the digestive system using a SmartPill capsule. The SmartPill is a pill about the size of a large multivitamin that can measure pH, pressure, and temperature changes, which it uses to assess where in the digestive tract it is. The participant swallows the pill, and carries around a receiver that is about the size of a deck of cards for the next 3-5 days. The SmartPill is expelled, and the receiver notifies the participant that they can return the receiver to the study personnel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI overweight-obese: 25.0-40 kg/m2
- •Colonoscopy within the last two years that found ≥1 adenoma
- •English speaking
- •Ambulatory, able to come to either food distribution site to pick up food and participate in clinical examinations and laboratory tests
排除标准
- •Serious medical condition (e.g., cancer, heart disease, kidney disease, diabetes)
- •History of CRC, bowel resection, polyposis syndrome, or inflammatory bowel disease
- •Smoked regularly in the past year
- •Dietary restrictions substantially limiting compliance or vegetarian or Vegan diet
- •Planning on changing diet or exercise behavior in the next 6 months
- •Regular use of medication that may alter inflammation markers, insulin, glucose, or gut function (i.e. regular use of non-steroidal anti-inflammatory medication, insulin therapy, steroid therapy, or antibiotics)
研究组 & 干预措施
Legume diet group
Meals will include approximately 1 ½ cups of cooked legumes, such as pinto, baked and navy beans as part of your 2 daily main dishes (lunch and dinner) and additional foods and snacks, preferably from the recommended healthy foods list. The smartpill will be administered at the end of the study.
干预措施: Legume diet group (Behavioral)
Legume diet group
Meals will include approximately 1 ½ cups of cooked legumes, such as pinto, baked and navy beans as part of your 2 daily main dishes (lunch and dinner) and additional foods and snacks, preferably from the recommended healthy foods list. The smartpill will be administered at the end of the study.
干预措施: Smartpill (Device)
Legume diet group
Meals will include approximately 1 ½ cups of cooked legumes, such as pinto, baked and navy beans as part of your 2 daily main dishes (lunch and dinner) and additional foods and snacks, preferably from the recommended healthy foods list. The smartpill will be administered at the end of the study.
干预措施: legumes (Other)
Control diet group
Meals will be healthy, typical American foods (without legumes) for 2 daily main dishes and additional foods and snacks, preferably from the recommended healthy foods list.The smartpill will be administered at the end of the study.
干预措施: Control diet group (Behavioral)
Control diet group
Meals will be healthy, typical American foods (without legumes) for 2 daily main dishes and additional foods and snacks, preferably from the recommended healthy foods list.The smartpill will be administered at the end of the study.
干预措施: Smartpill (Device)
结局指标
主要结局
Change in Weight
时间窗: Baseline to 8 weeks
Evaluate the effects of a high-legume diet compared to a control diet with a similar macronutrient profile on weight change in a randomized controlled feeding study.
次要结局
- Satiety(Time course response at baseline and 8 weeks)
- Gastric Emptying Time(8 weeks)
- Change in Plasma Insulin Level (Biomarker of Appetite Regulation)(Baseline to 8 weeks)
- Energy Intake(Baseline to 8 weeks)
研究者
Terry Hartman
Terry Hartman PhD, MPH, RD
Emory University