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

Last updated: April 29, 2025
Sponsor: Indena S.p.A
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Diabetes Prevention

Metabolic Syndrome

High Cholesterol (Hyperlipidemia)

Treatment

Placebo Tablets

MERIVA® Tablets

Clinical Study ID

NCT04705220
CUR-01-2019
  • Ages > 60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 cmfor 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 consentto participate.

  • Subjects willing and able to participate in the visits and in the proceduresforeseen by the study protocol.

Exclusion

Exclusion Criteria:

  • Subjects with dementia with MMSE <24 test and on therapy with cholinesteraseinhibitors or memantine*.

  • Subjects with serious concomitant internal medical conditions or with neurologicalpathologies 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 thetime of enrollment.

  • Subjects with known or suspected allergy or hypersensitivity to turmeric or othercomponents of the experimental / placebo product.

  • Subjects with Mild Cognitive Impairment (MCI) and in experimental therapy withAlzheimer'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, willbe subjected to the most appropriate therapies provided for the dementiapathology but will not enter the subsequent statistical evaluations.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Placebo Tablets
Phase:
Study Start date:
April 08, 2022
Estimated Completion Date:
October 16, 2025

Study 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.

Connect with a study center

  • S.C. di Endocrinologia e Diabetologia, Policlinico Universitario "Agostino Gemelli"

    Roma, 00168
    Italy

    Site Not Available

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