跳至主要内容
临床试验/NCT07398820
NCT07398820已完成不适用

Association of Sedentary Behavior and Physical Activity With Gut Transit Time and Its Effect on Gut Microbiota Inflammatory and Carcinogenic Potential

Clínica Universidad de los Andes1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Gut microbiota composition

研究概览

简要总结

This study seeks to determine the relationship between sedentary behavior, gut transit, gut microbiota and polyps development. Will be conducted an evaluation which includes assessments of physical activity behaviors (through accelerometry), gut transit time (ingestion of two blue colored muffins), food ingestion (online nutritional survey), body composition (through bioimpedance), heart rate variability (with a heart rate monitor) and gut microbiota composition (from a fecal sample).

The main goal of this study is to see if there is a relationship between high sedentary time and a slower gut transit time, altering gut microbiota favoring dysbiosis and promoting polyps development. For this objective, it will be described gut microbiota composition (identifying which bacteria are present in the gut and in what quantities are they found), physical activity and sedentary behaviors time, gut transit time (how long does it take to defecate after eating a meal) in order to relate these factors with the presence of polyps.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Both sexes.
  • 40-60 years of age.
  • Omnivorous diet.
  • Negative or positive colonoscopy result with adenomatous polyp during the last 12 months.

排除标准

  • Antibiotic treatment during the previous month.
  • Daily use of aspirin.
  • Chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis).
  • Chronic constipation or diarrheic syndrome.
  • Autoimmune disease (such as celiac disease, type 1 diabetes, etc.).
  • Food allergies.
  • Chronic use of laxatives.
  • Previous digestive surgery except appendicitis.
  • Familial adenomatous polyposis or Lynch disease.
  • Obesity (BMI>30) and/or type 2 diabetes mellitus.

研究组 & 干预措施

Control

Individuals who have undergone a colonoscopy with a normal result.

干预措施: Initial assessment (Other)

Polyps

Individuals who have undergone a colonoscopy with the result of colorectal adenoma

干预措施: Initial assessment (Other)

结局指标

主要结局

Gut microbiota composition

时间窗: From enrollment to the end of the 7 days period of recollection.

DNA will be extracted from fecal samples and will be sequenced by Illumina platform. After bioinformatics analysis, the alpha and beta diversity will be reported, as well as compositional data from single relevant taxa. Results will be expressed as relative abundance for each bacterial taxa.

Fecal metabolites

时间窗: 7 days after enrollment

Quantification of fecal short chain fatty acids (butyrate, propionate, acetate, valerate, isobutyrate and isovalerate) will be performed in a gas chromatograph. Concentration of other fecal metabolites derived from protein degradation will also be determined: ammonia by using a commercial kit; indole through colorimetry test; p-cresol and hydrogen sulfide will be identified using high performance liquid chromatography. Gut inflammation will be assessed through fecal calprotectin levels.

次要结局

  • Body composition(First day of enrollment)
  • Food ingestion(7 days from enrollment)
  • Gut transit time(From enrollment to the end of the 7 days period of recollection.)
  • Psychological well-being(7 days after enrollment)
  • Anxiety and depression(7 days after enrollment)
  • Physical activity and sedentary behavior(7 days after enrollment)
  • Heart rate variability(First day of enrollment)

研究者

发起方
Clínica Universidad de los Andes
申办方类型
Other
责任方
Principal Investigator
主要研究者

Javiera Cancino Ramirez

Principal investigator

Clínica Universidad de los Andes

研究点 (1)

Loading locations...

相似试验