Evaluation of the Impact of Medium-chain Fatty Acids in the Evolution of Newly Diagnosed Mild Cognitive Impairment: Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Effect of medium-chain triglycerides (MCT) intake on cognitive impairment
研究概览
简要总结
Mild cognitive impairment (MCI) is considered the intermediate stage between the changes observed in physiological aging and dementia. Currently, there is no drug therapy, and available drugs offer only minimal benefit on symptoms, only partially slowing the course of the condition. Studies in the literature have investigated the role of omega-3 fatty acids in MCI, and when administered over a period of six months, they appear to improve clinical condition and mood. In addition, medium-chain triglycerides (MCTs) appear to exert an antioxidant function, enhance cognitive ability in patients with MCI or Alzheimer's, and promote deep sleep state.
详细描述
Mild cognitive impairment (MCI) is considered the intermediate stage between the changes observed in physiological aging and dementia. The need to diagnose MCI at an early stage is driven by the hypothesis that therapeutic interventions may be more effective in the early stages of the disease. In addition, many studies have shown that sleep disturbances can affect neurodegeneration and be used as a marker of disease, manifesting before cognitive impairment itself. Currently, there is no drug therapy, and available drugs offer only minimal benefit on symptoms, only partially slowing the course of the condition. Studies in the literature have investigated the role of omega-3 fatty acids in MCI, and when administered over a period of six months, they appear to improve clinical condition and mood. In addition, medium-chain triglycerides (MCTs) appear to exert an antioxidant function, enhance cognitive ability in patients with MCI or Alzheimer's, and promote deep sleep state
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 85 years;
- •Diagnosis of MCI;
- •Disease duration of less than 24 months from symptom onset;
- •Absence of malnutrition (diagnosed according to the NRS 2002 screening test) and with oral intakes sufficient to cover energy requirements (calculated by the Harris-Benedict formula, adjusted for activity factor and pathology);
- •Ability to understand and sign informed consent.
排除标准
- •Patients on total or supplemental enteral nutrition
- •Severe dysphagia
- •Patients with glycated hemoglobin > 8%
- •Patients on insulin therapy
- •Patients with poor beta-cell function (e.g., pancreasectomy, acute and chronic pancreatitis)
- •Patients with liver failure: MELD score > 9
- •Malnutrition (diagnosed according to the NRS 2002 screening test) and with per os intakes < 60% of energy requirements (calculated using the Harris-Benedict formula, corrected for activity factor and pathology)
- •Metabolic disorders and/or enzyme disorders, dyslipidemia with total cholesterolemia >300 mg/dl and/or triglyceridemia >400 mg/dl)
- •Acute inflammatory disease or ongoing or recent (within 30 days) infectious states
- •Hypo- and hyperthyroidism not adequately compensated by treatment
- •Heart failure (NYHA III-IV), unstable angina, recent (<6 months) acute cardiovascular or cerebrovascular events
- •Pregnancy or lactation
- •Neurological disorders other than MCI, psychiatric disorders
- •Nutrition and eating disorder
- •Alcohol abuse
- •Institutionalized patients
- •Participation in experimental therapies in the 2 months prior to enrollment
- •Allergy to MCT oil, nuts
研究组 & 干预措施
Mediterranean-type food regimen using extra virgin olive oil
Patients with with first diagnosis of MCI referred to the S.C of Neurology and/or Geriatrics and/or Internal Medicine of the SS. Antonio e Biagio e Cesare Arrigo of Alessandria University Hospital, randomized into the control arm
干预措施: Mediterranean-type food regimen using extra virgin olive oil (Other)
Mediterranean-type diet with MCT supplementation
Patients with with first diagnosis of MCI referred to the S.C of Neurology and/or Geriatrics and/or Internal Medicine of the SS. Antonio e Biagio e Cesare Arrigo of Alessandria University Hospital, randomized into the experimental arm
干预措施: Mediterranean-type diet with MCT supplementation (Dietary Supplement)
结局指标
主要结局
Effect of medium-chain triglycerides (MCT) intake on cognitive impairment
时间窗: 6 months after baseline
Evaluate the effect of medium-chain triglycerides (MCT) intake on cognitive decline in patients with first diagnosis of MCI through the use of the Montreal Cognitive Assessment (MoCA), that includes a series of tests of visuospatial/executive functions, naming, attention, language, abstraction, delayed recall, and orientation for a total score of 30 (best cognitive status).
次要结局
- Positive effect of MCT intake on sleep quality(Baseline and 6 months after baseline)
- Evaluation of quality of life(Baseline, 3 months after baseline and 6 months after baseline)