Healthy, Colorectal Adenoma
Conditions
Keywords
exercise, sedentary behavior, colorectal cancer, gut microbiota
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.
Interventions
OTHERInitial assessment
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
Sponsors
Clínica Universidad de los Andes
University of Chile
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiota composition | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body composition | First day of enrollment | 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 |
| Food ingestion | 7 days from enrollment | Dietary intake will be assessed with a Food Frequency Questionnaire designed and performed by a trained dietitian. |
| Gut transit time | From enrollment to the end of the 7 days period of recollection. | 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. |
| Psychological well-being | 7 days after enrollment | 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. |
| Anxiety and depression | 7 days after enrollment | 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. |
| Physical activity and sedentary behavior | 7 days after enrollment | 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. |
| Heart rate variability | First day of enrollment | 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. |
Countries
Chile
Outcome results
None listed