Gut Flora Metabolite Reduction After Dietary Intervention (GRADY)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Change in TMAO level
研究概览
简要总结
Our group has recently identified the association between gut-flora-mediated carnitine and phosphatidylcholine metabolism, specifically trimethylamine-N-oxide (TMAO), and cardiovascular risk. This study investigates the ability for dietary intervention to modulate TMAO levels.
详细描述
This is a pilot human study to characterize the relationship between gut flora-associated TMAO generation and dietary intervention. The investigators hypothesize that tailored dietary interventions may help to reduce the ability for gut flora to generate TMAO in individuals with elevated TMAO levels. Specific aims include:
- To investigate the proportion of subjects with persistently elevated circulating TMAO levels.
- To compare the amount of TMAO generated from gut flora using stable-isotope-labelled choline, carnitine, and betaine in subjects with elevated versus normal circulating TMAO levels.
- To evaluate the effect of dietary interventions on the amount of TMAO generated from gut flora using stable-isotope-labelled choline, carnitine, and betaine in subjects with elevated circulating TMAO levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Cohort 1 Inclusion criteria:
- •Men and women age 18 years or above.
- •Elevated TMAO metabolizers (>5 µM) based on screening test and/or eGFR < 60 at most recent measurement.
- •Willing to remain on aspirin or able to be off aspirin or aspirin products for 1 week prior to starting the study and staying on the same aspirin regimen during the duration of the study.
- •Willing to sign the consent form and follow the study protocol, which includes a 12-week dietary modification.
- •Cohort 2 Inclusion criteria:
- •Men and women age 18 years or above.
- •Willing to remain on aspirin or able to be off aspirin or aspirin products for 1 week prior to starting the study and staying on the same aspirin regimen during the duration of the study.
- •Willing to sign the consent form and follow the study protocol.
- •eGFR values ranging from 16-59
- •Cohort 3 Inclusion criteria:
- •Men and women age 18 years or above.
- •Willing to remain on aspirin or able to be off aspirin or aspirin products for 1 week prior to starting the study and staying on the same aspirin regimen during the duration of the study.
- •Willing to sign the consent form and follow the study protocol.
排除标准
- •(all cohorts):
- •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 2 months of study enrollment
- •Use of over-the-counter probiotic within past month, or ingestion of yogurt within past 7 days
- •Having undergone bariatric procedures or surgeries such as gastric banding or bypass.
- •Pregnancy.
- •Any condition which, in the judgment of the Investigator, would place a patient at undue risk by being enrolled in the trial, or cause inability to comply with the trial
研究组 & 干预措施
MeLT Dietary intervention
Mediterranean Low-TMAO (MeLT) diet. Used in cohorts 1, 2 and 3.
干预措施: MeLT Dietary intervention (Behavioral)
TLC Dietary intervention
Therapeutic Lifestyle Changes (TLC) diet. Used in cohorts 1, 2 and 3.
干预措施: TLC Dietary intervention (Behavioral)
MeLT dietary intervention with TMAO
Mediterranean Low TMAO diet with TMAO levels reported. Used in cohort 1 only.
干预措施: MeLT dietary intervention with TMAO (Behavioral)
结局指标
主要结局
Change in TMAO level
时间窗: From baseline to 12 weeks follow-up
The change in TMAO concentration measured in blood samples
次要结局
未报告次要终点
研究者
Wilson Tang
Staff Cellular and Molecular Medicine and Cardiovascular Medicine
The Cleveland Clinic