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 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT06978504
Eligibility Criteria:
Inclusion Criteria:
* The study population will consist of menopausal women aged between 40 to 60 years old
* Obese (BMI \> 30) with a diagnosis of MS.
The inclusion criteria are the presence of at least 3 of the 5 criteria\* for MS, which include:
* Abnormal waist circumference values (≥89 cm in women)
* SBP ≥120 mm Hg and DBP ≥80 mm Hg) or diagnosis of hypertension
* Fasting blood glucose equal to or greater than 100 mg/dL or diagnosis of DM2
* HDL-c less than 50 mg/dL in women
* Triglycerides ≥150 mg/dL.
Exclusion Criteria:
* Patients with a BMI \<25 kg/m2
The following chronic diseases will not be eligible:
* Active cancer
* Active tuberculosis
* Psychiatric illnesses
* Multiple sclerosis
* Severe nephropathy
* Advanced stages of Paget's disease.
These chronic conditions could interfere with the results of this study, especially adherence to diet and weight loss. Patients who do not complete all stages of the study, who are not adhering to the intervention or who present any complication that interferes with the results of the study will be excluded from the study.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
60 Years
Study:
NCT06978504
Study Brief:
Protocol Section:
NCT06978504