Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 12:41 AM
NCT ID:
NCT02622867
Eligibility Criteria:
Inclusion Criteria:
* Men and women from 45 to 65 years old;
* Body Mass Index (BMI) ≥ 18,5 and \< 40 kg/m2
* Signed informed consent.
* Adequate cultural level and understanding for the clinical trial.
* Free of infections at baseline
Exclusion Criteria:
* Individuals with severe diseases (hepatic, kidney, cancer…);
* Individuals with diagnosed metabolic syndrome, diabetes and/or hyperthyroidism;
* Individuals with chronic intestinal pathologies (Gastritis, Colitis, Irritable Bowel Syndrome, Pseudomembranous Colitis, Crohn's disease…);
* Individuals with dementia, mental disease or low cognitive function;
* Individuals with autoimmune diseases and/or under treatment with corticosteroids and/or immunosuppressants;
* Individuals with major surgeries during the last month or gastrointestinal surgery in the last 3 months;
* Individuals treated with oral antibiotics during two weeks prior to the beginning of the study;
* Individuals undergoing dietary restriction and/or pharmacological treatment for the decrease of body weight 2 months prior to the beginning of the study;
* Individuals who intend to quit smoking during the next 20 weeks;
* Women that consume oral contraceptive;
* Pregnant women or breastfeeding;
* Individuals with intensive physical activity (\> 2 hours, more than 3 times per week);
* Individuals that consume antioxidant supplement, drugs, ω-3 supplements, vitamins, minerals, prebiotics or/and probiotics during the 2 weeks prior to the beginning of the study and that will not eliminate their consumption during the study;
* Individuals with regular consumption (\> 3 servings per week) of fermented foods (yogurt, actimel, kefir, blue cheese…) and/or use of other prebiotics and not to accept suppress their consumption during the study;
* Individuals with increased alcohol consumption \>30g/day (equivalent to 300 ml of wine, about 3 beers or a cup (75 ml) of whiskey , brandy , anise, etc);
* Individuals with regular use of laxatives (\> 2 a week) and (Laxbene, Miralax, Dulco - Lax, etc.) and does not accept suppress its consumption during the study period.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
65 Years
Study:
NCT02622867
Study Brief:
Protocol Section:
NCT02622867