HealthyNCT07398820
IMPACT OF SEDENTARY BEHAVIOR IN THE HOMEOSTASIS OF THE DIGESTIVE ECOSYSTEM
An observational study of Healthy and Colorectal Adenoma, run by Clínica Universidad de los Andes at 1 site in Chile.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Colorectal Adenoma
- What is being tested?
- Initial assessment
- How many people
- 80 participants
- Where
- 1 siteChile
- Study dates
- 1 May 2023to 30 Jun 2025
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Both sexes.
- 40-60 years of age.
- Omnivorous diet.
- Negative or positive colonoscopy result with adenomatous polyp during the last 12 months.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Chile1 site
Clínica Universidad de los Andes
Las Condes, Santiago Metropolitan, 26183000
About this study
Official title: Association of Sedentary Behavior and Physical Activity With Gut Transit Time and Its Effect on Gut Microbiota Inflammatory and Carcinogenic Potential
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
- Being tested
- Initial assessment
- Keywords
- exercise, sedentary behavior, colorectal cancer, gut microbiota
- Medical subject headings
- Motor Activity, Sedentary Behavior, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial assessmentOther
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
| Study group | Role | What they receive |
|---|---|---|
| Control | Individuals who have undergone a colonoscopy with a normal result. Receives: Other: Initial assessment | |
| Polyps | Individuals who have undergone a colonoscopy with the result of colorectal adenoma Receives: Other: Initial assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 7 days after enrollment
Secondary outcomes (7)
Body composition
Body composition will be assessed through octapolar bioimpedance. Individuals will have to stand barefoot in the scale and will be recorded:
- Weight
- Fat mass
- Fat free mass
Measured: First day of enrollment
Food ingestion
Dietary intake will be assessed with a Food Frequency Questionnaire designed and performed by a trained dietitian.
Measured: 7 days from enrollment
Gut transit time
Total gut transit time will be assessed through the blue dye method according to the protocol proposed by Asnicar et al. (2021). The subjects should eat two 'blue' muffins (84.5 g×2 with 0.75 g of Wilton 'royal blue' food coloring paste each) within a 10-minute period. For total gut transit time determination participants will be asked to register the day and hour of the first stool with blue dye along with their consistency based on Bristol scale. Bristol scale is a graded visual scale of stool type that gives a score from 1 (hard lumps) to 7 (watery diarrhea). Participants will have also a register sheet to write the day and hour of every spontaneous bowel movement during the week of use of the accelerometer. The register sheet must be returned to the investigator.
Measured: From enrollment to the end of the 7 days period of recollection.
Psychological well-being
Psychological well-being will be assessed through Ryff's Psychological Well-Being Scale . The shortened and validated Spanish version of Ryff's Scale will be used. The total score will be calculated by adding the scores for all question items. The higher the score, the better the psychological well-being is. The questionnaire will be sent to the subjects by e-mail.
Measured: 7 days after enrollment
Anxiety and depression
Anxiety and depression will be assessed through Hospital Anxiety and Depression Scale (HADS). The Spanish version of HADS will be used which comprises 14 items divided into two subscales, anxiety and depression, each one with 7 items. The items are assessed through a Likert scale ranging from 0 to 3, with a score of 0 to 7 indicating no symptoms; a score of 8 to 10 indicating borderline case; and a score of 11 to 21 indicating clear symptoms of depression and/or anxiety. The questionnaire will be sent to the subjects by e-mail.
Measured: 7 days after enrollment
Physical activity and sedentary behavior
Sedentary behavior will be assessed through accelerometry. The protocol for assessment and data analysis was adapted following the recommendations of Migueles et al. (2017). Accelerometers will be programmed to record at a frequency sampling of 90 Hz with a normal filter and with a time-sampling interval (epoch) every 60 seconds. Every subject should wear the accelerometer (wGT3X-BT, Actigraph) on their hip for 7 consecutive days during the 24 hours, except for water activities (shower and/or swimming). Non-wear-time will be defined as every period of more than 60 consecutive minutes with 0 counts per minute (cpm) and without interruptions. Every day with a wear-time of at least 16 hours will be considered as a valid day. Data will be considered valid when contain a record of at least four valid days including at least one day of the weekend. The acceleration and time spend in light, moderate and vigorous physical activity, as well as in sedentary behaviors will be reported.
Measured: 7 days after enrollment
Heart rate variability
Heart rate variability will be assessed with a polar H9 monitor worn in the chest for a 5 minutes period. Spectral analysis of the RR segments will be interpreted as follows: high frequency peak (HF; 0.15-0.4 Hz) representing primarily parasympathetic modulation, low frequency peak (LF; 0.04-0.15 Hz) reflecting both sympathetic and parasympathetic modulation. LF and HF power will be calculated in milliseconds2 (ms2). The LF/HF ratio will be used as a marker of the relative degree of sympathetic-cardiac modulation. Total power (ms2) was used as an indicator of the overall variability of the RR intervals.
Measured: First day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start1 May 2023
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Clínica Universidad de los Andes
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chile
- Responsible party
- Principal investigator, Javiera Cancino Ramirez, Clínica Universidad de los Andes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398820
- Sponsor's protocol ID
- FAIN202201
- Status last verified
- Feb 2026
- First submitted
- 7 Nov 2024
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Gut microbiota FASTQ files along with the metadata will be upload to the open data repository Zenodo.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Sedentary Behavior and Physical Activity With Gut Transit Time and Its Effect on Gut Microbiota Inflammatory and Carcinogenic Potential
- ClinicalTrials.gov ID
- NCT07398820
- Acronym / sponsor ID
- FAIN202201
- Conditions
- Healthy, Colorectal Adenoma
- Keywords
- exercise, sedentary behavior, colorectal cancer, gut microbiota
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Clínica Universidad de los AndesUniversity, hospital or other
- Collaborators
- University of Chile
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: Initial assessmentIndividuals who have undergone a colonoscopy with a normal result. |
| Polyps | – | Other: Initial assessmentIndividuals who have undergone a colonoscopy with the result of colorectal adenoma |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- Both sexes.
- 40-60 years of age.
- Omnivorous diet.
- Negative or positive colonoscopy result with adenomatous polyp during the last 12 months.
Key exclusion criteria (11 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Initial assessmentPatients 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 | Other | Control, Polyps |
Primary outcome
Gut microbiota composition
Time frame: 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
Time frame: 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.
7 secondary outcomes
Body composition
Time frame: First day of enrollment
Food ingestion
Time frame: 7 days from enrollment
Gut transit time
Time frame: From enrollment to the end of the 7 days period of recollection.
Psychological well-being
Time frame: 7 days after enrollment
Anxiety and depression
Time frame: 7 days after enrollment
Physical activity and sedentary behavior
Time frame: 7 days after enrollment
Heart rate variability
Time frame: First day of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: Yes. Gut microbiota FASTQ files along with the metadata will be upload to the open data repository Zenodo.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Colorectal Adenoma, run by Clínica Universidad de los Andes at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiota composition (time frame: From enrollment to the end of the 7 days period of recollection.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.