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

Primary Purpose

Mild Cognitive Impairment

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

MERIVA® Tablets

Placebo Tablets

About this trial

This is an interventional other trial for Mild Cognitive Impairment focused on measuring Metabolic Syndrome, Curcumin, Mild Cognitive Impairment, Nutraceutical, Nutritional Supplementation

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nutritional Supplementation with Test Product

Control Group without Nutritional Supplementation

Arm 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).

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.

Outcomes

Primary Outcome Measures

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 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.

Secondary Outcome Measures

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

Evaluation in comparison to baseline of the neuropsychological measurement performed regarding memory tests (Rey's Auditory Verbal Learning Test - RAVLT). Any differences between the groups treated with MERIVA® versus placebo will be recorded. The differences between genders are considered.

Change from Baseline of Trail Making Test (TMT) Test

Evaluation in comparison to baseline of the neuropsychological measurement performed regarding executive functions and attention (Trail Making Test - TMT). Any differences between the groups treated with MERIVA® versus placebo will be recorded. The differences between genders are considered.

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

Evaluation in comparison to baseline of the neuropsychological measurement performed regarding executive functions and attention (Multiple Features Target Cancellation - MFTC). Any differences between the groups treated with MERIVA® versus placebo will be recorded. The differences between genders are considered.

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

Evaluation in comparison to baseline of the neuropsychological measurement performed regarding language (Phonological and Semantic Verbal Fluidity - FVS). Any differences between the groups treated with MERIVA® versus placebo will be recorded. The differences between genders are considered.

Change from Baseline of Geriatric Depression Scale (GDS) Test

Evaluation in comparison to baseline of the neuropsychological measurement performed regarding a neuropsychiatric scale (Geriatric Depression Scale - GDS). Any differences between the groups treated with MERIVA® versus placebo will be recorded. The differences between genders are considered.

Change from Baseline of Neuro-Psychiatric Inventory (NPI) Test

Evaluation in comparison to baseline of the neuropsychological measurement performed regarding a neuropsychiatric scale (Neuro-Psychiatric Inventory - NPI). Any differences between the groups treated with MERIVA® versus placebo will be recorded. The differences between genders are considered.

Change from Baseline of Basic Activities of Daily Living (BADL) Test

Evaluation in comparison to baseline of the neuropsychological measurement performed regarding the ability to live everyday (Basic Activities of Daily Living - BADL). Any differences between the groups treated with MERIVA® versus placebo will be recorded. The differences between genders are considered.

Change from Baseline of Instrumental Activities of Daily Living (IADL) Test

Evaluation in comparison to baseline of the neuropsychological measurement performed regarding the ability to live everyday (Instrumental Activities of Daily Living - IADL). Any differences between the groups treated with MERIVA® versus placebo will be recorded. The differences between genders are considered.

Change from Baseline of Stroop Test - Short Version

Evaluation in comparison to baseline of the neuropsychological measurement performed regarding executive functions and attention (Stroop test short version). Any differences between the groups treated with MERIVA® versus placebo will be recorded. The differences between genders are considered.

Change from Baseline of Bioelectrical Impedance (BIA) Assessment

Evaluation in comparison to baseline of body composition by bioelectrical impedance (BIA). Any differences between the groups treated with MERIVA® versus placebo will be recorded. The differences between genders are considered.

Change from Baseline of Metabolism Parameters measured in Blood

Evaluation in comparison to baseline of metabolism changes (blood panel including: total cholesterol, Low-Density Lipoproteins, High-Density Lipoproteins, insulin, triglycerides, glucose, creatinine, uric acid, electrolytes, hepatic transaminases, gamma-glutamyltransferase, total proteins). In particular, any differences in terms of fasting blood glucose reduction and Homeostatic Model Assessment (HOMA) Index between the groups treated with MERIVA® versus placebo will be recorded. The differences between genders are considered.

Change from Baseline of Lipid and Immune Profile measured in Blood

Evaluation in comparison to baseline of the lipid and immune profile of subjects treated with MERIVA® versus placebo. In particular, an omic-type approach will reveal alterations in lipid and energy metabolism, including lipoproteins, low molecular weight metabolites and individual lipid molecules, together with their degree of (poly) (non) saturation (blood panel including: leptin, adiponectin, Brain-derived Neurotrophic Factor, proinflammatory mediators such as Tumor Necrosis Factor alpha, interleukin-1 beta and interleukin-6, prostaglandins and reactive species of oxygen / nitrogen, inflammasome). The differences between genders are considered.

Change from Baseline of Brain-Derived Neurotrophic Factor (BDNF) and p66Shc Gene Expression measured in Blood

Evaluation in comparison to baseline of the lipid and immune profile of subjects treated with MERIVA® versus placebo. In particular, a sample of Peripheral Blood Mononuclear Cells (PBMC) will be separated for the measurement of the expression, by means of real-time Polymerase Chain Reaction (RT-PCR), of the neurotrophin Brain-Derived Neurotrophic Factor (BDNF) and of the p66Shc gene, which are involved in the response to lifestyle changes, including diets and exercise. The differences between genders are considered.

Rate and Characterization of Adverse Events occurred to Subjects

Evaluation of the number, rate and characteristics of the adverse events occurring to subjects treated with MERIVA® versus placebo. The differences between genders are considered.

Full Information

NCT ID

NCT04705220

First Posted

December 6, 2019

Last Updated

October 16, 2023

Sponsor

Indena S.p.A

Collaborators

Istituto Superiore di Sanità, Sintesi Research Srl

1. Study Identification

Unique Protocol Identification Number

NCT04705220

Brief Title

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

Acronym

EPICURO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 8, 2022 (Actual)

Primary Completion Date

March 18, 2025 (Anticipated)

Study Completion Date

March 18, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Indena S.p.A

Collaborators

Istituto Superiore di Sanità, Sintesi Research Srl

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment

Keywords

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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).

Masking

ParticipantInvestigator

Masking Description

The test product MERIVA® is formulated in tablets indistinguishable from those of its correspondent placebo, with a completely indistinguishable appearance even in packaging.

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nutritional Supplementation with Test Product

Arm Type

Experimental

Arm Description

Arm Title

Control Group without Nutritional Supplementation

Arm Type

Placebo Comparator

Arm 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.

Intervention Type

Dietary Supplement

Intervention Name(s)

MERIVA® Tablets

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo Tablets

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

Change from Baseline of Montreal Cognitive Assessment (MOCA) Test

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

Change from Baseline of Trail Making Test (TMT) Test

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

Change from Baseline of Geriatric Depression Scale (GDS) Test

Description

Time Frame

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

Title

Change from Baseline of Neuro-Psychiatric Inventory (NPI) Test

Description

Time Frame

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

Title

Change from Baseline of Basic Activities of Daily Living (BADL) Test

Description

Time Frame

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

Title

Change from Baseline of Instrumental Activities of Daily Living (IADL) Test

Description

Time Frame

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

Title

Change from Baseline of Stroop Test - Short Version

Description

Time Frame

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

Title

Change from Baseline of Bioelectrical Impedance (BIA) Assessment

Description

Time Frame

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

Title

Change from Baseline of Metabolism Parameters measured in Blood

Description

Time Frame

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

Title

Change from Baseline of Lipid and Immune Profile measured in Blood

Description

Time Frame

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

Title

Change from Baseline of Brain-Derived Neurotrophic Factor (BDNF) and p66Shc Gene Expression measured in Blood

Description

Time Frame

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

Title

Rate and Characterization of Adverse Events occurred to Subjects

Description

Evaluation of the number, rate and characteristics of the adverse events occurring to subjects treated with MERIVA® versus placebo. The differences between genders are considered.

Time Frame

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 Pre-specified Outcome Measures:

Title

Intestinal Microbiotic Profile Assessment in Stool Sample

Description

Evaluation in comparison to baseline of the intestinal microbiotic profile of subjects. Any differences between the groups treated with MERIVA® versus placebo will be recorded. The differences between genders are considered.

Time Frame

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

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

Patients enrolled will be randomized in a 1:1 ratio between groups and sexes.

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Danila Marchioretto

Phone

+39-0226291629

dmarchioretto@scharper.it

First Name & Middle Initial & Last Name or Official Title & Degree

Francesca Cirulli

Phone

+39-0649902480

francesca.cirulli@iss.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrea Giaccari, Prof.

Organizational Affiliation

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Roma

ZIP/Postal Code

00168

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrea Giaccari, Prof.

Phone

+39-0630154440

andrea.giaccari@unicatt.it

First Name & Middle Initial & Last Name & Degree

Simona Moffa, MD

First Name & Middle Initial & Last Name & Degree

Camillo Marra, Prof.

12. IPD Sharing Statement

Plan to Share IPD

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Links:

URL

http://www.indena.com/

Description

Sponsor company website

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

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