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 @ 4:33 AM
Ignite Modification Date:
2025-12-25 @ 4:33 AM
NCT ID:
NCT04011618
Eligibility Criteria:
Inclusion Criteria:
* Metabolic Syndrome diagnosis based on IDF criteria
* Acceptance and signing of Informed Consent
Exclusion Criteria:
* Prior diagnosis of kidney, liver, pancreas, heart or thyroid disease
* Diabetes mellitus or arterial hypertension
* Alcoholism, drug abuse or tobacco use
* Systolic blood pressure ≥140 mmHg
* Diastolic blood pressure ≥90 mmHg
* Fasting plasma glucose ≥126 mg/dL
* TG ≥500 mg/dL
* C-LDL \> 190 mg/dL
* BMI: ≥35 kg/m2
* Pregnancy (suspected or confirmed) or lactation
* Menopausal period \<1 year
* Hormonal contraceptive or replacement therapy
* Known allergy to any of the interventions
* Imposibility to shallow capsules
* Pharmacological, dietary or herbal therapy in the last 3 months before trial
* Weight variability above ±2.0 kg throughout the last 3 months before intervention
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
59 Years
Study:
NCT04011618
Study Brief:
Protocol Section:
NCT04011618