Effect of Nutritional Supplementation With Turmeric on the Cognitive Performance of Subjects With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Change from Baseline of Mini-Mental State Examination (MMSE) Test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
The test product MERIVA® is formulated in tablets indistinguishable from those of its correspondent placebo, with a completely indistinguishable appearance even in packaging.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: MERIVA® Tablets (Dietary Supplement)
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.
干预措施: Placebo Tablets (Other)
结局指标
主要结局
Change from Baseline of Mini-Mental State Examination (MMSE) Test
时间窗: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
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
时间窗: Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).
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.
次要结局
- Change from Baseline of Instrumental Activities of Daily Living (IADL) Test(Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).)
- Change from Baseline of Basic Activities of Daily Living (BADL) 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 Geriatric Depression Scale (GDS) Test(Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).)
- Change from Baseline of Bioelectrical Impedance (BIA) Assessment(Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).)
- Change from Baseline of Metabolism Parameters measured in Blood(Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).)
- 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 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 Neuro-Psychiatric Inventory (NPI) Test(Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).)
- Change from Baseline of Stroop Test - Short Version(Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).)
- Rate and Characterization of Adverse Events occurred to Subjects(Pre-Screening (T-1) / Baseline (T0) / After 3 months of treatment (T3) / After 6 months of treatment (T6) / After 12 months of treatment (T12).)
- Change from Baseline of Lipid and Immune Profile measured in Blood(Change from Baseline (T0) to 6 months of treatment (T6) and 12 months of treatment (T12).)
- Change from Baseline of Brain-Derived Neurotrophic Factor (BDNF) and p66Shc Gene Expression measured in Blood(Change from Baseline (T0) to 6 months of treatment (T6).)