Effects of Ultra Processed Food on Intestinal Energy Harvest
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Fecal energy loss
研究概览
简要总结
Ultra processed food is everywhere in modern society and may contain multiple ingredients that affect the way participants' bodies store energy. Some studies have shown that eating a diet high in ultra processed foods leads to weight gain, but these foods have not been studied enough to understand why. Recently, the gut microbiome has become a potential way to measure energy balance in the human body; this is done by measuring how many calories are in the stool. The investigators propose to test a very high ultra-processed food diet where 80% of calories are coming from ultra processed food and a low ultra processed food diet where 20% of the calories are coming from ultra processed food. This study will compare stool sample energy content of the two diets.
详细描述
This study will recruit people with obesity who are otherwise healthy to participate in this study. Each person will go through baseline testing before starting any of the diets. This consists of one blood draw, one metabolic test which requires each person to remain awake in a small, enclosed room that measures oxygen and carbon dioxide consumption, and one body composition test. Participants will also meet with a study dietitian to review their diet, how to track their diet, and how to collect and ship the stool samples. Each person will be assigned to either 80% or 20% level of ultra processed food in the diet to start and will continue this diet for two weeks. After the first diet phase, each participant will enter a washout period where they will return to eating however they wish and will not need to participate in any research activities. After the two weeks, each participant will return to begin another series of tests and begin the second two-week diet phase. The whole study will take approximately 9 weeks to complete.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI 30-40kg/m2
- •weight stable
- •able to download app and willing to use it for duration of study
- •does own grocery shopping
- •otherwise healthy
排除标准
- •pregnancy
- •history of or planned bariatric surgery
- •history of anti obesity medications
研究组 & 干预措施
80% Ultra processed
Participants will be provided with shopping lists and menus for the two arms of the diet intervention.
干预措施: Diet containing 80% ultra processed foods (Behavioral)
20% Ultra processed
Participants will be provided with shopping lists and menus for the two arms of the diet intervention.
干预措施: Diet containing 20% ultra processed foods (Behavioral)
结局指标
主要结局
Fecal energy loss
时间窗: 2 weeks
Amount of calories absorbed from diet will be the difference from energy intake - calories in stool
次要结局
- Microbial taxa(2 weeks)
研究者
Faris M Zuraikat, PhD
Assistant Professor of Nutritional Medicine
Columbia University