NCT03080675已完成不适用
Trial of a Nutritional Blend to Prevent Cognitive Decline in Older Adults
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 362 人开始时间: 2016年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 362
- 试验地点
- 2
- 主要终点
- Changes at 1 year in levels of nutritional risk factors involved in cognitive in cognitive decline with ageing relative to baseline
研究概览
简要总结
To demonstrate the beneficial effects of 1-year intervention with a nutritional blend of ingredients on blood levels of nutritional biomarkers known to be linked with cognitive decline in non-demented adults with subjective memory concerns aged 70+ years
详细描述
This multicenter 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 (placebo or nutrition product). The duration of the intervention is 1 year.
The total sample size at baseline is 364 subjects, consisting of non-demented adults with subjective memory concerns aged 70+ years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 70 years
- •Spontaneous memory complaints
- •Adequate fluency in the local language to understand the inform consent form and complete any other study document
- •Sufficient vision and hearing to complete study protocol procedures based on medical judgement
- •Has a study partner that is willing to participate as a source of information and has at least weekly contact with the participant (contact can be in-person, via telephone or electronic communication)
- •Has general health status that will not interfere with the ability to complete the study
- •Willing and able to participate and to give written consent to comply with study procedures
- •Willing to be informed in case a new clinical pathology is discovered through clinical examinations
排除标准
- •Exhibiting a loss of independence in basic activities of daily living (ADL score < 4)
- •MMSE score < 24
- •Dementia as determined by DSM-V criteria
- •Suffering from diseases that are likely to be life-threatening in the short-term
- •History or presence of a severe disease (e.g., cardiovascular, hepatic, renal (e.g., End Stage Renal Disease), gastroenteral, respiratory, endocrine, neurologic, psychiatric, immunologic, or hematologic disease or other conditions) that could, in the opinion of the investigator, interfere with the subjects safety or ability to complete the trial
- •Food allergy
- •Taking omega-3 dietary supplements containing >200 mg DHA per day during the last 6 months
- •Receiving or having received in the past 3 months a physician prescribed vitamin B12, B3 or vitamin B-complex
- •Receiving Alzheimer's Disease medication (Galantamine, Memantine Donezepil and Rivastigmine)
- •Deprived of their liberty by administrative or judicial decision, or under guardianship or admitted to a healthcare or social institution (subjects in non-assisted living facilities could be recruited).
- •Having participated in another clinical study in the previous month or is currently participating in another study.
- •Subjects meeting one or more of the following criteria below will not be included in the PET scan and MRI-scan subset groups:
- •Wearing a pace-maker or having metal in the body which is exclusionary for MRI
- •Claustrophobic
- •Subjects who will participate in the PET-scan and MRI-scan subset groups, will be excluded for a 1-year period of any future projects involving investigations using ionizing radiation.
研究组 & 干预措施
Experimental
Experimental
Nutritional blend of ingrédients including vitamins and fish oil
干预措施: Nutrional blend of ingredients including vitamins and fish oil (Dietary Supplement)
Control comparator:
Placebo Comparator
control product does not contain any of the active ingredients and is matched for carbohydrate content to the active intervention.
干预措施: Control (Dietary Supplement)
结局指标
主要结局
Changes at 1 year in levels of nutritional risk factors involved in cognitive in cognitive decline with ageing relative to baseline
时间窗: [Time Frame: 1 year] [Safety Issue: No]
Homocysteine levels
Changes at 1 year in levels of nutritional risk factors involved in cognitive decline with ageing relative to baseline
时间窗: [Time Frame: 1 year] [Safety Issue: No]
Plasma erythrocyte-omega 3 index
次要结局
- Changes in cognitive function assessed by the Category Naming Test (CNT) at 0, 6 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Cognitive status changes assessed by the Logical Memory subtest of the WMS-R Test at 0, 6 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Change in clinical status assessed by Clinical Dementia Rating (CDR) at 0 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Changes in cognitive function assessed by the WAIS-IV coding test at 0, 6 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Cognitive status changes assessed by the Letter Fluency Test at 0, 6 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Change in cognitive function determined by a composite Z-score from 4 neuropsychological tests (see description) at 0, 6 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Cognitive function assessed by the (Mini Mental Scale Examination) MMSE total score at 6 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Cognitive status changes assessed by the Stroop Color Word Test (SCWT) at 0, 6 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Cognitive status changes assessed by the Digit Span (DS) at 0, 6 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Change in cognitive impairment assessed by the Clinical Dementia Rating - Sum of Boxes (CDR-SOB) at 0 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Changes in depression, anxiety and psychiatric symptoms assessed by the Neuropsychiatric Inventory Questionnaire (NPI-Q) at 0 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Changes in brain structure assessed by Magnetic Resonance Imaging (MRI) in a subset of the study population at 0 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Changes in brain function assessed by resting State fMRI in a subset of the study population at 0 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Changes in cognitive function assessed by the FCSRT (Free and Cued Selective Reminding Test) at 0, 6 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Changes in cognitive function assessed by the Orientation score from the Mini Mental Scale Examination (MMSE) at 0, 6 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Cognitive status changes assessed by the Trail Making Test parts A and B at 0, 6 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Subjective change in cognitive function assessed by the PROMIS Applied Cognition - Abilities instrument, Cognitive Function Instrument at 0, 1 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Subjective change in quality of life and health status assessed by the EQ-5D-5L questionnaire at 0 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Changes in depression status assessed by the Geriatric depression scale (GDS) at 0 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Changes in physical functions assessed by the Short Physical Performance Battery (SPPB) at 0, 6 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Changes in brain structure assessed by MRI diffusion tensor imaging (DTI) in a subset of the study population at 0 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Changes in levels of biomarkers associated with cognitive decline: Aβ40 levels at 0, 6 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Changes in levels of biomarkers associated with cognitive decline: Aβ42 levels at 0, 6 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Changes in levels of biomarkers associated with cognitive decline: Tau protein levels at 0, 6 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Changes in levels of plasma nutrient levels at 0, 6 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Changes in frailty syndromes assessed by the Fried Frailty Criteria at 0 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Changes in brain structure assessed by fluid-attenuated inversion recovery (FLAIR) MRI and diffusion tensor imaging (DTI) in a subset of the study population at 0 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Changes in brain function assessed by Arterial spin label (ASL) perfusion MRI in a subset of the study population at 0 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Changes in brain function assessed by Amyloid Florbetapir Positron Emission Tomography (PET) in a subset of the study population at baseline([Time Frame: 1 years] [Safety Issue: No])
- Changes in levels of biomarkers associated with cognitive decline: BDNF levels at 0, 6 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Changes in levels of biomarkers associated with cognitive decline: Asymmetric dimethylarginine levels at 0, 6 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Changes in levels of biomarkers associated with cognitive decline: Homocysteine levels at 0, 6 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Changes in levels of blood plasma inflammatory markers 0, 6 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Changes in levels of blood plasma markers of oxidative stress at 0, 6 and 12 months([Time Frame: 1 year] [Safety Issue: No])
- Treatment effects in a subgroup population defined by the below described subject characteristic:([Time Frame: 1 year] [Safety Issue: No])
研究者
研究点 (2)
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