Clinical trial NCT04705220: Effect of Nutritional Supplementation With Turmeric on the Cognitive Performance of Subjects With Metabolic Syndrome
Official title: Effect of Nutritional Supplementation With Turmeric on the Cognitive Performance of Subjects With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Metabolic Syndrome
Curcumin
Mild Cognitive Impairment
Nutraceutical
Nutritional Supplementation
Lead sponsor: Indena S.p.A
Sponsor class: INDUSTRY
Collaborators: name: Istituto Superiore di Sanità
name: Sintesi Research Srl
First posted: 2021-01-12
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline of Mini-Mental State Examination (MMSE) Test
timeFrame: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
measure: Change from Baseline of Montreal Cognitive Assessment (MOCA) Test
timeFrame: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
Secondary outcomes:
measure: Change from Baseline of Rey's Auditory Verbal Learning Test (RAVLT) Test
timeFrame: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
measure: Change from Baseline of Trail Making Test (TMT) Test
timeFrame: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
measure: Change from Baseline of Multiple Features Target Cancellation (MFTC) Test
timeFrame: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
measure: Change from Baseline of Phonological and Semantic Verbal Fluidity (FVS) Test
timeFrame: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
measure: Change from Baseline of Geriatric Depression Scale (GDS) Test
timeFrame: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
measure: Change from Baseline of Neuro-Psychiatric Inventory (NPI) Test
timeFrame: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
measure: Change from Baseline of Basic Activities of Daily Living (BADL) Test
timeFrame: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
measure: Change from Baseline of Instrumental Activities of Daily Living (IADL) Test
timeFrame: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
measure: Change from Baseline of Stroop Test - Short Version
timeFrame: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
measure: Change from Baseline of Bioelectrical Impedance (BIA) Assessment
timeFrame: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
measure: Change from Baseline of Metabolism Parameters measured in Blood
timeFrame: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
measure: Change from Baseline of Lipid and Immune Profile measured in Blood
timeFrame: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
measure: Change from Baseline of Brain-Derived Neurotrophic Factor (BDNF) and p66Shc Gene Expression measured in Blood
timeFrame: Change from Baseline (T0) to 6 months of treatment (T6).
measure: Rate and Characterization of Adverse Events occurred to Subjects
timeFrame: Pre-Screening (T-1) / Baseline (T0) / After 3 months of treatment (T3) / After 6 months of treatment (T6) / After 12 months of treatment (T12).
Other outcomes:
measure: Intestinal Microbiotic Profile Assessment in Stool Sample
timeFrame: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
Locations:
city: Roma
country: Italy
facility: S.C. di Endocrinologia e Diabetologia, Policlinico Universitario "Agostino Gemelli"
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Andrea Giaccari, Prof.
role: PRINCIPAL_INVESTIGATOR
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