Dietary Green Tea Confection For Resolving Gut Permeability-Induced Metabolic Endotoxemia In Obese Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Endotoxin
研究概览
简要总结
This study is focused on assessing gastrointestinal-level improvements by which green tea limits metabolic endotoxemia. It is completed in two phases. Phase I consists of a pharmacokinetic study to examine the bioavailability of green tea catechins among lean and obese persons who consumed a single dose of a green tea extract (GTE)-containing confection. These persons will then complete phase 2, which consists of a parallel design randomized controlled in which lean and obese persons will consume placebo or GTE confections.
It is expected that catechin-rich green tea will improve gut barrier function to prevent endotoxin translocation and associated low-grade inflammation. Outcomes will therefore support dietary recommendations for green tea to alleviate obesity-related inflammatory responses. Specifically, the study is expected to demonstrate that a green tea confection snack food can attenuate metabolic endotoxemia in association with restoring gastrointestinal health.
详细描述
Obesity is a major public health concern in the United States, with over two-thirds of the adult population classified as overweight or obese. Obesity is characterized by low-grade chronic inflammation that, in part, is mediated by metabolic endotoxemia. Metabolic endotoxemia describes increased circulating levels of gut-derived endotoxin (a bacterial product derived from Gram-negative bacteria in the intestines) that results from gut barrier dysfunction, a phenomenon that is common in obesity. Studies in rodents models have shown that dietary supplementation with green tea extract (GTE) reduces metabolic endotoxemia in association with improved gut health. This clinical trial will therefore investigate the extent to which a green tea confection snack food can alleviate metabolic endotoxemia and restore gut health in obese humans. It is hypothesized that 4-week daily ingestion of a green tea extract (GTE)-rich confection will limit metabolic endotoxemia by decreasing gut barrier permeability. This study will address the following objectives: 1) define alterations in catechin pharmacokinetics in obese compared with healthy adults, 2) demonstrate improvements in gut barrier function by GTE, and 3) demonstrate GTE-mediated amelioration of microbial dysbiosis.
To test the hypothesis, all participants will initially complete a 12-h pharmacokinetics study to define the influence of obesity on catechin bioavailability and metabolism. They will then be randomized to complete a double-blind, randomized, placebo-controlled trial where they will receive a GTE-rich or placebo confection for 4 weeks. Prior to and upon completing the intervention, participants will undergo a gut permeability test, fecal samples will be collected for microbiota composition analysis, and blood samples will be collected to assess endotoxin and inflammatory biomarkers. Upon successfully completing this study, it is anticipated that chronic consumption of a green tea confection will be demonstrated to be an effective dietary strategy to reduce metabolic endotoxemia and improve gut health.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overweight/obese (BMI = 28-40 kg/m2)
- •Fasting glucose < 126 mg/dL
- •Normotensive (blood pressure < 140/90 mmHg)
- •Non-dietary supplement user
- •Non-smoker
排除标准
- •Regular tea drinkers (> 2 cups/week)
- •Vegetarians
- •Use of medications to manage diabetes, hypertension, or hyperlipidemia
- •Use of any medications known to be contraindicated for use with green tea ingestion
- •User of dietary supplements, prebiotics, or probiotics
- •Recent use of antibiotics or anti-inflammatory agents
- •Women who are pregnant or lactating or have initiated or changed birth control in the past 3-months
- •Individuals with gastrointestinal disorders or surgeries
- •Individuals with hemochromatosis
- •Alcohol intake > 3 drinks per day
- •Any history of cancer
结局指标
主要结局
Endotoxin
时间窗: Week 4 - Fasting
Serum endotoxin concentration
次要结局
- Calprotectin(Week 4)
- Gut Permeability - Lactulose to Mannitol Ratio(Week 4 - 6-24 hours)
- Gut Permeability - Sucralose to Erythritol Ratio(Week 4 - 0-24 hours)
- Urinary Sucralose/Erythritol Ratio (mg/mg)(Week 4 - 6-24 hours)
- Firmicutes to Bacteroidetes Ratio - Microbiota(Week 4)
- Bioavailability - Epigallocatechin Gallate(Prior to intervention enrollment...0-12 hours post-ingestion of a green tea confection)
- Bioavailability - Epigallocatechin(Prior to intervention enrollment...0-12 hours post-ingestion of a green tea confection)
- Bioavailability - Epicatechin Gallate(Prior to the intervention enrollment...0-12 hours post-ingestion of a green tea confection)
- Bioavailability - Epicatechin(Prior to intervention enrollment...0-12 hours post-ingestion of a green tea confection)
- Cmax of Epigallocatechin Gallate(Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection)
- Cmax of Epigallocatechin(Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection)
- Cmax of Epicatechin Gallate(Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection)
- Cmax of Epicatechin(Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection)
- Tmax of Epigallocatechin Gallate(Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection)
- Tmax of Epigallocatechin(Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection)
- Tmax of Epicatechin Gallate(Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection)
- Tmax of Epicatechin(Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection)
研究者
Richard Bruno
Professor
Ohio State University