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临床试验/NCT05743790
NCT05743790已完成不适用

The Role of Dietary Intake and Host Genetics in Gut Microbiome Response to Resistant Starch Consumption

Cornell University2 个研究点 分布在 1 个国家目标入组 196 人开始时间: 2019年9月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
196
试验地点
2
主要终点
Gut microbiome

研究概览

简要总结

Resistant starch (RS), a type of dietary fiber, was shown to have beneficial effects on human health through its impact on microbes present in the intestine. However, the effects of RS on the gut microbiota and in turn, on human health, can vary between individuals. Consequently, everyone may not reap the same health benefits by eating high amounts of RS. Factors predicting how an individual's gut microbes as well as the beneficial metabolites produced by these microbes respond to RS supplementation would be helpful in developing precision nutrition approaches that maximize the benefits of dietary fiber intake. The objective of this study was to evaluate candidate predictors of gut microbiota response to RS supplementation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
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

入选标准

  • Above 18 years of age
  • Willing to consume the supplements provided throughout the duration of the study

排除标准

  • History of diabetes, prediabetes or impaired glucose tolerance.
  • Existing, UNTREATED, thyroid condition.
  • Usage of systemic antibiotics (intravenous injection, intramuscular, or oral) within 6 months prior to the study.
  • Acute disease at the time of enrollment.
  • Chronic, clinically significant pulmonary, cardiovascular, gastrointestinal, hepatic, or renal functional abnormality.
  • History of active UNTREATED gastrointestinal disorders or diseases including:
  • i. Inflammatory bowel disease (IBD) ii. Ulcerative colitis (mild-moderate-severe) iii. Crohn's disease (mild- moderate-severe) iv. Indeterminate colitis v. Irritable bowel syndrome (IBS) (moderate-severe) vi. Persistent, infectious gastroenteritis, colitis or gastritis vii. Persistent or chronic diarrhea of unknown etiology viii. Clostridium difficile infection (recurrent) ix. Chronic constipation
  • Suspected state of immunosuppression or immunodeficiency including HIV.
  • History of bariatric surgery.
  • Pregnant or lactating women.

结局指标

主要结局

Gut microbiome

时间窗: 7 weeks

16S rRNA gene survey of gut microbial communities

Fecal short-chain fatty acid concentration

时间窗: 7 weeks

Fecal short-chain fatty acid concentration measurements with ultra-performance liquid chromatography

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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