Clinical trial · Observational
IMPACT OF SEDENTARY BEHAVIOR IN THE HOMEOSTASIS OF THE DIGESTIVE ECOSYSTEM
Association of Sedentary Behavior and Physical Activity With Gut Transit Time and Its Effect on Gut Microbiota Inflammatory and Carcinogenic Potential
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Adenoma | Colorectal Adenoma | ONTOLOGY_EXACT | 0.98 |
| Healthy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Initial assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Control
- description
- Individuals who have undergone a colonoscopy with a normal result.
- interventionNames
- Other: Initial assessment
- label
- Polyps
- description
- Individuals who have undergone a colonoscopy with the result of colorectal adenoma
- interventionNames
- Other: Initial assessment
Primary outcomes (2)
- measure
- Gut microbiota composition
- timeFrame
- From enrollment to the end of the 7 days period of recollection.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Both sexes. * 40-60 years of age. * Omnivorous diet. * Negative or positive colonoscopy result with adenomatous polyp during the last 12 months. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available