IMPACT OF SEDENTARY BEHAVIOR IN THE HOMEOSTASIS OF THE DIGESTIVE ECOSYSTEM (NCT07398820) | Clinical Trial Compass
CompletedNot Applicable
IMPACT OF SEDENTARY BEHAVIOR IN THE HOMEOSTASIS OF THE DIGESTIVE ECOSYSTEM
Chile80 participantsStarted 2023-05-01
Plain-language 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.
Who can participate
Age range
40 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Gut microbiota composition
Timeframe: From enrollment to the end of the 7 days period of recollection.