Effect of Nutritional Supplementation With Turmeric on the Cognitive Performance of Subjects With Metabolic Syndrome — EPICURO  

Mild Cognitive Impairment Clinical Trial

Official title: Effect of Nutritional Supplementation With Turmeric on the Cognitive Performance of Subjects With Metabolic Syndrome

Status Recruiting

Clinical Trial 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 together with cognitive performance, potentially resulting in the reduction of the risk of cognitive decline in subjects, male and female, with Metabolic Syndrome. The results obtained will provide novel insights on MERIVA® for improving the prevention of age-related cognitive decline and Alzheimer's disease.

Clinical Trial 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). The duration of the supplementation is 6 months. The total sample size at baseline is 100 subjects aged 60+ years with Metabolic Syndrome, and therefore at risk of cognitive decline but without definite cognitive pathologies.

The primary objective of the study is the evaluation of the effect of nutritional supplementation with MERIVA® on the cognitive performance of subjects with Metabolic Syndrome, and therefore at risk of cognitive decline, with a view to maintaining the homeostatic balance of the function.

The secondary objectives of the study are:

• Evaluation of the effect of nutritional supplementation with turmeric (MERIVA®) on memory, executive and attention functions, language, neuropsychiatric profile and daily living ability of Subjects with Metabolic Syndrome;

• Evaluation of the effect of nutritional supplementation with turmeric (MERIVA®) on the body composition of Subjects with Metabolic Syndrome;

• Evaluation of the effect of nutritional supplementation with turmeric (MERIVA®) on the arterial properties of Subjects with Metabolic Syndrome;

• Evaluation of the effect of nutritional supplementation with turmeric (MERIVA®) on glucose metabolism and on the lipid and immune structure of Subjects with Metabolic Syndrome;

• Evaluation of the influence of gender / gender on the response to nutritional supplementation with turmeric (MERIVA®) in Subjects with Metabolic Syndrome;

• Confirmation of the safety profile of nutritional supplementation with turmeric (MERIVA®) in Subjects with Metabolic Syndrome. ;

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Metabolic Syndrome
• Mild Cognitive Impairment

• NCT number: NCT04705220
• Study type: Interventional
• Source: Indena S.p.A
• Contact: Danila Marchioretto
• Phone: +39-0226291629
• Email: dmarchioretto@scharper.it
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2022
• Completion date: March 18, 2025