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| Name | Class |
|---|---|
| University of Chile | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Individuals who have undergone a colonoscopy with a normal result. |
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| Polyps | Individuals who have undergone a colonoscopy with the result of colorectal adenoma |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Initial assessment | Other | Patients will be cited to the clinic for an initial assessment that will include:
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition | Body composition will be assessed through octapolar bioimpedance. Individuals will have to stand barefoot in the scale and will be recorded:
| First day of enrollment |
| Food ingestion |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clínica Universidad de los Andes | Las Condes | Santiago Metropolitan | 26183000 | Chile |
Gut microbiota FASTQ files along with the metadata will be upload to the open data repository Zenodo.
Six months after publication
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.
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D057185 | Sedentary Behavior |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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Fecal samples
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Dietary intake will be assessed with a Food Frequency Questionnaire designed and performed by a trained dietitian.
| 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. | 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. | 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. | 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. | 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. | First day of enrollment |
| D009371 |
| Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |