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

Indena

Status: Active, not recruiting

Conditions: Mild Cognitive Impairment

Treatments: Other: Placebo Tablets; Dietary Supplement: MERIVA® Tablets

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04705220

CUR-01-2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Nutritional Supplementation with Test Product

Experimental group

Description:

Subjects will receive 1 tablet of MERIVA® in two administrations per day (one in the morning, one in the evening during meals) for a period of 6 months. This treatment corresponds to 1 g / day of experimental product (corresponding to about 200 mg of curcuminoids).

Treatment:

Dietary Supplement: MERIVA® Tablets

Control Group without Nutritional Supplementation

Placebo Comparator group

Description:

Subjects will receive 1 tablet of placebo in two administrations per day (one in the morning, one in the evening during meals) for a period of 6 months.

Treatment:

Other: Placebo Tablets