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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT04705220
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects.
* Subjects aged ≥ 60 years.
* Subjects with Metabolic Syndrome diagnosed according to standard criteria:
1. Presence of abdominal obesity (waist circumference\> 94 cm for males and\> 80 cm for females).
In addition, at least two of the following alterations:
2. Fasting blood glucose ≥ 100 mg / dl.
3. Triglycerides ≥ 150 mg / dl.
4. HDL cholesterol \<40 mg / dl for males, \<50 mg / dl for females.
5. Arterial hypertension (≥ 135/85 mmHg).
* Subjects who understand the nature of the study and provide their informed consent to participate.
* Subjects willing and able to participate in the visits and in the procedures foreseen by the study protocol.
Exclusion Criteria:
* Subjects with dementia with MMSE \<24 test and on therapy with cholinesterase inhibitors or memantine\*.
* Subjects with serious concomitant internal medical conditions or with neurological pathologies capable of causing cognitive dysfunction.
* Subjects with hepato-biliary disorders, including bile duct obstruction, cholangitis, gallstones.
* Subjects addicted to alcohol or drugs, or treated with psychotropic drugs at the time of enrollment.
* Subjects with known or suspected allergy or hypersensitivity to turmeric or other components of the experimental / placebo product.
* Subjects with Mild Cognitive Impairment (MCI) and in experimental therapy with Alzheimer's disease drugs.
* Subjects who are participating or have participated in other clinical studies within 30 days before enrollment.
* Subjects unable to sign the Informed Consent to Participation.
* In case of conversion to dementia the Subjects will be kept in the study, will be subjected to the most appropriate therapies provided for the dementia pathology but will not enter the subsequent statistical evaluations.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT04705220
Study Brief:
Protocol Section:
NCT04705220