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

NCT04705220 | Completed

• 1 other identifier: CUR-01-2019
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Mild Cognitive Impairment

Keywords

Metabolic Syndrome; Curcumin; Mild Cognitive Impairment; Nutraceutical; Nutritional Supplementation

Outcome Measures

Primary Outcomes (2)

• Change from Baseline of Mini-Mental State Examination (MMSE) Test

  Percentage of subjects showing an improvement in performance in Mini-Mental State Examination (MMSE) test in comparison to baseline, defined as an increase of more than 2 points in the test. A difference between the group treated with MERIVA® versus placebo of at least 20% in the proportion of subjects with clinical improvement as defined above is considered clinically relevant. The differences between genders are considered.

  Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).

• Change from Baseline of Montreal Cognitive Assessment (MOCA) Test

  Percentage of subjects showing an improvement in performance in Montreal Cognitive Assessment (MOCA) test in comparison to baseline, defined as an increase of more than 2 points in the test. A difference between the group treated with MERIVA® versus placebo of at least 20% in the proportion of subjects with clinical improvement as defined above is considered clinically relevant. The differences between genders are considered.

  Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).

Secondary Outcomes (14)

• Change from Baseline of Rey's Auditory Verbal Learning Test (RAVLT) Test

  Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).

• Change from Baseline of Trail Making Test (TMT) Test

  Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).

• Change from Baseline of Multiple Features Target Cancellation (MFTC) Test

  Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).

• Change from Baseline of Phonological and Semantic Verbal Fluidity (FVS) Test

  Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).

• Change from Baseline of Geriatric Depression Scale (GDS) Test

  Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).

Other Outcomes (1)

• Intestinal Microbiotic Profile Assessment in Stool Sample

  Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).

Study Arms (2)

Nutritional Supplementation with Test Product

EXPERIMENTAL

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).

Dietary Supplement: MERIVA® Tablets

Control Group without Nutritional Supplementation

PLACEBO COMPARATOR

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.

Other: Placebo Tablets

Interventions

MERIVA® Tablets DIETARY_SUPPLEMENT

The treatment corresponds to 1 g / day of experimental product (corresponding to about 200 mg of curcuminoids).

Nutritional Supplementation with Test Product

Placebo Tablets OTHER

The composition of placebo includes the same components of the treatment tablets, except for the active substance.

Control Group without Nutritional Supplementation

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indena S.p.A: lead
• Istituto Superiore di Sanità: collaborator
• Sintesi Research Srl: collaborator

Study Sites (1)

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

Roma, 00168, Italy

Location

Related Publications (12)

• Petersen RC, Caracciolo B, Brayne C, Gauthier S, Jelic V, Fratiglioni L. Mild cognitive impairment: a concept in evolution. J Intern Med. 2014 Mar;275(3):214-28. doi: 10.1111/joim.12190.

  PMID: 24605806 BACKGROUND

• McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21.

  PMID: 21514250 BACKGROUND

• Mrak RE, Griffin WS. Potential inflammatory biomarkers in Alzheimer's disease. J Alzheimers Dis. 2005 Mar;8(4):369-75. doi: 10.3233/jad-2005-8406.

  PMID: 16556968 BACKGROUND

• Schrijvers EM, Witteman JC, Sijbrands EJ, Hofman A, Koudstaal PJ, Breteler MM. Insulin metabolism and the risk of Alzheimer disease: the Rotterdam Study. Neurology. 2010 Nov 30;75(22):1982-7. doi: 10.1212/WNL.0b013e3181ffe4f6.

  PMID: 21115952 BACKGROUND

• Matsuzaki T, Sasaki K, Tanizaki Y, Hata J, Fujimi K, Matsui Y, Sekita A, Suzuki SO, Kanba S, Kiyohara Y, Iwaki T. Insulin resistance is associated with the pathology of Alzheimer disease: the Hisayama study. Neurology. 2010 Aug 31;75(9):764-70. doi: 10.1212/WNL.0b013e3181eee25f. Epub 2010 Aug 25.

  PMID: 20739649 BACKGROUND

• Cicero AFG, Fogacci F, Morbini M, Colletti A, Bove M, Veronesi M, Giovannini M, Borghi C. Nutraceutical Effects on Glucose and Lipid Metabolism in Patients with Impaired Fasting Glucose: A Pilot, Double-Blind, Placebo-Controlled, Randomized Clinical Trial on a Combined Product. High Blood Press Cardiovasc Prev. 2017 Sep;24(3):283-288. doi: 10.1007/s40292-017-0206-3. Epub 2017 May 23.

  PMID: 28537012 BACKGROUND

• Giugliano G, Salemme A, De Longis S, Perrotta M, D'Angelosante V, Landolfi A, Izzo R, Trimarco V. Effects of a new nutraceutical combination on cognitive function in hypertensive patients. Immun Ageing. 2018 Feb 7;15:7. doi: 10.1186/s12979-017-0113-4. eCollection 2018.

  PMID: 29445414 BACKGROUND

• Cox KH, Pipingas A, Scholey AB. Investigation of the effects of solid lipid curcumin on cognition and mood in a healthy older population. J Psychopharmacol. 2015 May;29(5):642-51. doi: 10.1177/0269881114552744. Epub 2014 Oct 2.

  PMID: 25277322 BACKGROUND

• Tabrizi R, Vakili S, Lankarani KB, Akbari M, Mirhosseini N, Ghayour-Mobarhan M, Ferns G, Karamali F, Karamali M, Taghizadeh M, Kouchaki E, Asemi Z. The Effects of Curcumin on Glycemic Control and Lipid Profiles Among Patients with Metabolic Syndrome and Related Disorders: A Systematic Review and Metaanalysis of Randomized Controlled Trials. Curr Pharm Des. 2018;24(27):3184-3199. doi: 10.2174/1381612824666180828162053.

  PMID: 30156145 BACKGROUND

• Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21.

  PMID: 21514249 BACKGROUND

• Berry A, Cirulli F. The p66(Shc) gene paves the way for healthspan: evolutionary and mechanistic perspectives. Neurosci Biobehav Rev. 2013 Jun;37(5):790-802. doi: 10.1016/j.neubiorev.2013.03.005. Epub 2013 Mar 20.

  PMID: 23524280 BACKGROUND

• Berry A, Bucci M, Raggi C, Eriksson JG, Guzzardi MA, Nuutila P, Huovinen V, Iozzo P, Cirulli F. Dynamic changes in p66Shc mRNA expression in peripheral blood mononuclear cells following resistance training intervention in old frail women born to obese mothers: a pilot study. Aging Clin Exp Res. 2018 Jul;30(7):871-876. doi: 10.1007/s40520-017-0834-4. Epub 2017 Sep 26.

  PMID: 28952131 BACKGROUND

Related Links

• Sponsor company website

MeSH Terms

Conditions

Cognitive Dysfunction; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Andrea Giaccari, Prof.

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The test product MERIVA® is formulated in tablets indistinguishable from those of its correspondent placebo, with a completely indistinguishable appearance even in packaging.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a double-blind, randomized, single-center clinical trial. Patients enrolled will be randomized in a 1:1 ratio between groups and sexes to receive the test product MERIVA® (Group A) or its correspondent placebo (Group B).

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: January 12, 2021
• Study Start: April 8, 2022
• Primary Completion: October 16, 2025
• Study Completion: December 19, 2025
• Last Updated: February 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)