Effect of Nutritional Supplementation With Turmeric on the Cognitive Performance of Subjects With Metabolic Syndrome
NCT ID: NCT04705220
Last Updated: 2026-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
85 participants
INTERVENTIONAL
2022-04-08
2025-12-19
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Nutritional Supplementation with Test Product
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).
MERIVA® Tablets
The treatment corresponds to 1 g / day of experimental product (corresponding to about 200 mg of curcuminoids).
Control Group without Nutritional Supplementation
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.
Placebo Tablets
The composition of placebo includes the same components of the treatment tablets, except for the active substance.
Interventions
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MERIVA® Tablets
The treatment corresponds to 1 g / day of experimental product (corresponding to about 200 mg of curcuminoids).
Placebo Tablets
The composition of placebo includes the same components of the treatment tablets, except for the active substance.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
60 Years
ALL
No
Sponsors
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Istituto Superiore di Sanità
OTHER
Sintesi Research Srl
INDUSTRY
Indena S.p.A
INDUSTRY
Responsible Party
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Principal Investigators
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Andrea Giaccari, Prof.
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Locations
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S.C. di Endocrinologia e Diabetologia, Policlinico Universitario "Agostino Gemelli"
Roma, , Italy
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Sponsor company website
Other Identifiers
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CUR-01-2019
Identifier Type: -
Identifier Source: org_study_id
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