Personalized Gastrointestinal Motility Responses to Dietary Fiber and Gut Microbial Metabolites
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Luminal pH (pH units)
研究概览
简要总结
The goal of this randomized, crossover, clinical trial is to link: 1) gastrointestinal motility patterns induced by acute consumption of whole and refined grains, 2) enteric microbial production of bioactive metabolites, and 3) circulating postprandial appearance of metabolites important to cardiometabolic health including glucose, triglycerides, and cholesterol.
Participants will be asked to consume a Smartpill monitoring device that records metrics of gastrointestinal motility in response to whole or refined grains, monitor cardiometabolic metabolties over an 8 hour postprandial window, and provide a fecal sample for microbiome-related analyses.
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
盲法说明
Appearance, flavor, and texture of whole grain vs refined bread could not be masked
入排标准
- 年龄范围
- 21 Years 至 63 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women
排除标准
- •Physician-Diagnosed:
- •Diabetes Mellitus
- •Nutrient-malabsorption disorders
- •Intestinal Bowel Syndrome (IBS)
- •Intestinal Bowel Disease (IBD)
- •Bleeding-related disorders
- •Grain allergy
- •Psychological Disorders
- •Dysphasia
- •History of:
- •Bariatric Surgery
- •Gallbladder removal
- •Eating disorders
- •Antibiotic administration (within the past three months)
- •Hormone therapy
- •Using statins
- •Pregnant, lactating, or postmenopausal
- •Taking oral hypoglycemic agents or insulin
- •Ingesting prescription fiber
- •Using cholesterol and bile acid absorption inhibitors
- •Ingesting nutrition supplements, not including a daily multivitamin (i.e. herbs, tinctures, and extracts) •Using recreational drugs or alcohol (within the past week)
- •Taking anti-histamines
- •Taking proton pump inhibitors
- •Taking antacids
结局指标
主要结局
Luminal pH (pH units)
时间窗: From consumption of bread and Smartpill to deification (single meal consumption, GI motility times vary based on participant, but could be estimated from around 16 hours to 5 days)
pH of gastrointestinal contents as captured by the Medtronic Smartpill capsule
Temperature (degrees celcius)
时间窗: From consumption of bread and Smartpill to deification (single meal consumption, GI motility times vary based on participant, but could be estimated from around 16 hours to 5 days)
Temperature in the intestinal lumen as captured by the Medtronic Smartpill capsule
Gastrointestinal Pressure (mmHg)
时间窗: From consumption of bread and Smartpill to deification (single meal consumption, GI motility times vary based on participant, but could be estimated from around 16 hours to 5 days)
Pressure of gastrointestinal contractions as captured by the Medtronic Smartpill capsule temperature, transit time)
Gastrointestinal Transit Time (hours:minutes)
时间窗: From consumption of bread and Smartpill to deification (single meal consumption, GI motility times vary based on participant, but could be estimated from around 16 hours to 5 days)
Duration of gastrointestinal transit as captured by the Medtronic Smartpill capsule
Total Cholesterol
时间窗: Baseline to 8 hours post bread and Smartpill consumption (baseline, 0.5 hours, 1 hour, 1.5 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, and 8 hours)
Concentration of total cholesterol in whole blood from finger prick as measured by the Konsung Portable Dry Biochemical Analyzer
LDL cholesterol
时间窗: Baseline to 8 hours post bread and Smartpill consumption (baseline, 0.5 hours, 1 hour, 1.5 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, and 8 hours)
Concentration of LDL choelsterol in whole blood from finger prick as measured by the Konsung Portable Dry Biochemical Analyzer
Blood Glucose
时间窗: Baseline to 8 hours post bread and Smartpill consumption (baseline, 0.5 hours, 1 hour, 1.5 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, and 8 hours)
Concentration of glucose in whole blood from finger prick as measured by the Konsung Portable Dry Biochemical Analyzer
Triglycerides
时间窗: Baseline to 8 hours post bread and Smartpill consumption (baseline, 0.5 hours, 1 hour, 1.5 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, and 8 hours)
Concentration of triglycerides in whole blood from finger prick as measured by the Konsung Portable Dry Biochemical Analyzer
HDL cholesterol
时间窗: Baseline to 8 hours post bread and Smartpill consumption (baseline, 0.5 hours, 1 hour, 1.5 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, and 8 hours)
Concentration of HDL cholesterol in whole blood from finger prick as measured by the Konsung Portable Dry Biochemical Analyzer
Lipopolysaccharide Binding Protein
时间窗: Baseline to 8 hours post bread and Smartpill consumption (baseline, 0.5 hours, 1 hour, 1.5 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, and 8 hours)
Concentration of LBP in whole blood from finger prick as measured by ELISA
次要结局
- Microbiome(Fecal sample following ingestion of the Smartpill and test meal (approximately 24 hours into the study arm))
- Metabolomics(Fecal sample following ingestion of the Smartpill and test meal (approximately 24 hours into the study arm))