Analysis of MicroBial Metabolites After Eating Refined Food
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Serial changes in plasma and urine metabolites and biomarkers
研究概览
简要总结
The purpose of this study is to learn more about what happens in the human body after consuming a meal that contains ultra-processed foods like hamburgers, and if this is different to what happens after consuming a meal that contains lots of whole foods, like fresh vegetables, instead.
详细描述
The purpose of this study is to discover more about how the human body and the bacteria living in our intestines, known as "gut flora," react to different foods a person may consume. The investigators want to know if there are differences in compounds measured in a participant's blood and urine after eating different foods. Specifically, the investigators are interested in seeing if there are differences in these compounds after eating ultra-processed foods, like hamburgers and french fries, versus eating whole foods, like fresh fruits and vegetables. The investigators also want to know if the bacteria in our intestines may change the levels of these compounds. To this end, some subjects will be asked to take antibiotics to suppress the gut flora for three days before eating the challenge meal. Suppression of gut flora is a known effect of the antibiotics used in this study. Participants will have two study visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women age 18 years or above.
- •Able to provide informed consent and comply with study protocol
- •Able to remain on a stable aspirin regimen (either on or off aspirin or aspirin products) for 1 week prior to starting study until the end of the study period.
排除标准
- •Significant chronic illness or end-organ dysfunction, including known history of uncompensated heart failure, renal failure, pulmonary disease, hematologic diseases.
- •Active infection or received antibiotics within 6 months of study enrollment.
- •Use of over-the-counter probiotic within past month.
- •Chronic gastrointestinal disorders.
- •Intolerance to probiotic therapy.
- •Allergy to vancomycin, ciprofloxacin, neomycin, metronidazole, or lactose.
- •Allergy to any of the food components of the challenge meals.
- •Having undergone bariatric procedures or surgeries such as gastric banding or bypass.
- •Pregnancy.
研究组 & 干预措施
Arm 1: Ultra-processed Meal + Antibiotics to supress gut flora
Subjects in Arm 1 will take antibiotics for 3 days before the meal challenge to suppress the gut flora. The antibiotics to be used are: vancomycin, 125 mg three times daily; metronidazole, 500 mg twice daily; ciprofloxacin, 500 mg twice daily; and neomycin, 1 gram three times daily. These subjects will then consume a challenge meal of ultra-processed foods.
干预措施: Ultra-processed Food Meal (Other)
Arm 2: Ultra-processed Meal + No Antibiotics
Subjects in Arm 2 will not take any antibiotics prior to the meal challenge. They will consume a challenge meal of ultra-processed foods.
干预措施: Ultra-processed Food Meal (Other)
Arm 3: Whole Food Meal + Antibiotics to supress gut flora
Subjects in Arm 3 will take antibiotics for 3 days before the meal challenge to suppress the gut flora. The antibiotics to be used are: vancomycin, 125 mg three times daily; metronidazole, 500 mg twice daily; ciprofloxacin, 500 mg twice daily; and neomycin, 1 gram three times daily. These subjects will then consume a challenge meal of whole, unprocessed foods.
干预措施: Whole Food Meal (Other)
Arm 4: Whole Food Meal + No Antibiotics
Subjects in Arm 4 will not take any antibiotics prior to the meal challenge. They will consume a challenge meal of whole, unprocessed foods.
干预措施: Whole Food Meal (Other)
结局指标
主要结局
Serial changes in plasma and urine metabolites and biomarkers
时间窗: Pre-meal (baseline) & post-meal at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours
Serial changes in plasma and urine metabolites and biomarkers
Serial changes in plasma and urine TMAO
时间窗: Pre-meal (baseline) & post-meal at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours
Serial changes in plasma and urine TMAO (trimethylamine N-oxide)
次要结局
未报告次要终点
研究者
Wilson Tang
Staff Physician
The Cleveland Clinic