Status:
ACTIVE_NOT_RECRUITING
Effect of Nutritional Supplementation With Turmeric on the Cognitive Performance of Subjects With Metabolic Syndrome
Lead Sponsor:
Indena S.p.A
Collaborating Sponsors:
Istituto Superiore di Sanità
Sintesi Research Srl
Conditions:
Mild Cognitive Impairment
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
The EPICURO study aims to demonstrate the beneficial effects of a 6-month dietary supplementation with an improved bioavailable turmeric (MERIVA®) on inflammatory, oxidative and metabolic parameters t...
Detailed Description
This single-center trial will be a placebo-controlled, double-blind, randomized, 2 parallel groups study. The subjects will be randomly allocated to one of two treatment groups (MERIVA® or placebo). T...
Eligibility Criteria
Inclusion
- Male or female subjects.
- Subjects aged ≥ 60 years.
- Subjects with Metabolic Syndrome diagnosed according to standard criteria:
- Presence of abdominal obesity (waist circumference\> 94 cm for males and\> 80 cm for females).
- In addition, at least two of the following alterations:
- Fasting blood glucose ≥ 100 mg / dl.
- Triglycerides ≥ 150 mg / dl.
- HDL cholesterol \<40 mg / dl for males, \<50 mg / dl for females.
- 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
- 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.
Key Trial Info
Start Date :
April 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 16 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04705220
Start Date
April 8 2022
End Date
October 16 2025
Last Update
May 1 2025
Active Locations (1)
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1
S.C. di Endocrinologia e Diabetologia, Policlinico Universitario "Agostino Gemelli"
Roma, Italy, 00168