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 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT02630602
Eligibility Criteria:
Inclusion Criteria:
* Volunteers with overweight type II or obesity type I or II (IMC ≥27\<40 Kg/m2).
* Cardiovascular risk \< 10% and almost two of follow factors:
Men ≥ 45 years old or women ≥ 55 years old; Familiar background of premature cardiovascular disease; HDL cholesterol \<40 mg/dL for men and \<50 mg/dL for women; Total cholesterol ≥ 200 mg/dL; Triglycerides ≥ 150 mg/dL and \< 200 mg/dL; LDL ≥ 130 mg/dL and \< 160 mg/dL; Smoker
* Accept advises to perform a balanced hypocaloric diet and regular practice of physical activity.
* Signed informed consent.
Exclusion Criteria:
* Individuals with Diabetes Mellitus type 1;
* Individuals with Diabetes Mellitus type 2, using medication;
* Individuals with Dyslipidemia, using drug;
* Individuals with high blood pressure, using medication;
* Individuals with allergies to dairy protein;
* Individuals with severe diseases (hepatic, kidney, cancer…);
* Individuals with drugs or supplements consumption to weight lost;
* Individuals that consume drugs, ω-3 supplements or supplement that can modify the lipid and / or glucose profile (statins, fibrates, diuretics, corticosteroids, insulin…);
* Individuals who have participated in programs and / or clinical trials of weight control in the last 6 months;
* Individuals with increased alcohol consumption 30g/day;
* Individuals that stop smoking in the next 20 weeks (during the study);
* Individuals with mental disease or low cognitive function;
* Pregnant women or breastfeeding;
* Individuals with intensive physical activity;
* Individuals with physical problems complying with the recommendations of physical activity and diet general recommendations.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02630602
Study Brief:
Protocol Section:
NCT02630602