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:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT05454904
Eligibility Criteria:
Inclusion Criteria:
Adult men or women 25-70 years-old with existing metabolic syndrome defined as the presence of at least three of the following criteria: (i) abdominal obesity (waist circumference \>90 cm in men or \>80 cm in women), (ii) low HDL-cholesterol (\<40 mg/dl in men or \<50 mg/dl in women) or under HDL increasing drugs, (iii) high triglycerides (TG) (≥ 150 mg/dl) or under TG lowering drugs, (iv) high blood hypertension (blood pressure ≥ 130/85 mmHg) or under treatment, and (v) high blood glucose (fasting plasma glucose concentration ≥ 100 mg/dl) or under treatment.
Exclusion Criteria:
* Absence of written informed consent
* Inability/low chance of adherence to diets or attend scheduled visits
* Allergy or intolerance to foods included in either interventional diets
* Recent (\<12 months) participation in weight loss program
* Obesity with BMI \>35 kg/m2 or due to endocrine diseases, with exception of treated hypothyroidism
* Type 1 diabetes, unstable type 2 diabetes
* Uncontrolled high blood pressure
* Previous clinical atherosclerotic cardiovascular disease
* Use of medications such as weight loss drugs, oral corticoids, immunosuppressants or cytotoxic agents
* Advanced chronic liver disease
* Previous organ transplantation
* History of HIV-positive status or AIDS
* History of inflammatory bowel disease or major gastrointestinal surgery (bariatric surgery, bowel resection)
* Active psychiatric conditions: eating disorders, severe depression, bipolar disorder, schizophrenia
* Short (\<2 years) life expectancy
* Current or previous (within the last year) participation in other clinical trials with dietary or drug interventions
* Institutionalized subjects
* Additional conditions that may limit adherence to the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
70 Years
Study:
NCT05454904
Study Brief:
Protocol Section:
NCT05454904