IMPACT OF SEDENTARY BEHAVIOR IN THE HOMEOSTASIS OF THE DIGESTIVE ECOSYSTEM

NCT07398820 | Completed

• 1 other identifier: FAIN202201
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Colorectal Adenoma

Keywords

exercise; sedentary behavior; colorectal cancer; gut microbiota

Outcome Measures

Primary Outcomes (2)

• Gut microbiota composition

  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.

  From enrollment to the end of the 7 days period of recollection.

• Fecal metabolites

  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.

  7 days after enrollment

Secondary Outcomes (7)

• 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

Study Arms (2)

Control

Individuals who have undergone a colonoscopy with a normal result.

Other: Initial assessment

Polyps

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

Other: Initial assessment

Interventions

Initial assessment OTHER

Patients will be cited to the clinic for an initial assessment that will include: * Brief interview to identify health conditions and medicines * Fecal sample recollection for determination of gut microbiota composition * Physical activity assessment with 7-day accelerometry * Body composition through octopolar bioimpedance * Heart rate variability with a heart rate monitor * Food ingestion through a questionnaire

Control; Polyps

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients' recruitment will be conducted at Clínica Universidad de los Andes. Universe will include all subjects between 40-60 years of age who have undergone a colonoscopy during the previous year at Clínica Universidad de los Andes with a negative (control) or positive result with the presence of adenomatous polyp.

You may qualify if:

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

You may not qualify if:

• 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.).
• HIV.
• 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.

Sponsors & Collaborators

• Clínica Universidad de los Andes: lead
• University of Chile: collaborator

Study Sites (1)

Clínica Universidad de los Andes

Las Condes, Santiago Metropolitan, 26183000, Chile

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fecal samples

MeSH Terms

Conditions

Motor Activity; Sedentary Behavior; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Behavior; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: February 10, 2026
• Study Start: May 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Six months after publication
• Access Criteria: The FASTQ files will be available in the open repository ZENODO with the relevant metadata. Any other information can be requested by email supported by a proposal that should describe planned analyses.

Locations

CL (1)