Feasibility and Efficacy of Dietary Interventions for Older Adults With Subjective Cognitive Decline
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in Memory Functioning Questionnaire (MFQ)
研究概览
简要总结
This study aims to assess if/how dietary interventions (i.e., the Modified Atkins Diet (MAD) and/or the Mediterranean-Dietary Approaches to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay (MIND)) might prevent, delay onset, alleviate symptoms, or otherwise alter the course of subjective cognitive decline (SCD) likely due to Alzheimer's disease (AD).
We hypothesize that participants will tolerate both diets well and that the MAD will result in more favorable changes in cognition and other functioning.
详细描述
Specific aims are to 1) to establish the feasibility of implementing the MAD in older adults with subjective cognitive decline (SCD) likely due to AD, 2) to examine whether changes in participants' cognition, mood, or other functioning are more favorable in patients using the MAD than in patients using the MIND diet, 3) to assess the role of Apolipoprotein E (ApoE) epsilon 4 genotype in response to the MAD in individuals with SCD. We hypothesize that 1) participants will be able to adhere to and tolerate the MAD and the MIND, determined by review of patients' food records and urine ketone production, 2) participants who adhere to the MAD will demonstrate a more favorable change on neuropsychological tests than participants on the MIND diet, and 4) the neuropsychological effects of the MAD will be greatest in those participants without a ε4 allele of the ApoE gene.
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
- Single (Outcomes Assessor)
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
- •Self-experienced persistent decline in cognitive capacity compared with a previously normal status that is unrelated to an acute event and that is not explained by a psychiatric disorder or neurological disease apart from Alzheimer's disease, medical disorder, medication, or substance use, with the onset of decline no longer than 5 years prior to study participation
- •Clinical Dementia Rating (CDR) score equal to 0
- •Montreal Cognitive Assessment (MoCA) equal to or greater than 26
- •Age 60 years or older
- •Personal physician clearance
- •Willing to comply with all requirements of the study protocol and provide informed consent
排除标准
- •Diagnosis of mild cognitive impairment (MCI), Alzheimer's disease (AD), or other dementia
- •Current psychiatric diagnosis
- •Unstable metabolic condition (documented on screening laboratory studies performed within the past year)
- •persistent hyponatremia (sodium < 130 mg/dL twice within the past year)
- •severe hypernatremia (sodium > 150 mg/dL twice within the past year)
- •hypoglycemia (glucose < 50 mg/dL)
- •hypocalcemia (albumin-corrected calcium < 8 mg/dL)
- •Type-I diabetes
- •Type-2 diabetes requiring any medication other than metformin. (Please note that patients with type-2 diabetes may require medication adjustment if on the very low-carb modified Atkins diet.)
- •Liver failure
- •Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or ammonia > 5x upper limits of normal
- •hyperbilirubinemia
- •total bilirubin > 15 mg/dL
- •direct bilirubin > 5 mg/dL
- •Hypercholesterolemia (on medication, if needed)
- •fasting total cholesterol > 300 mg/dL
- •fasting LDL cholesterol > 200 mg/dL
- •Known fatty acid oxidation disorder or pyruvate carboxylase deficiency
- •Body mass index < 18.5
- •History of ischemic or hemorrhagic stroke
- •History of nephrolithiasis
- •History of myocardial infarction or known coronary artery disease
- •Acute pancreatitis
- •Multiple food allergies or strict dietary requirements
- •Any other concerns about nutritional status (e.g., recent unexplained weight loss, difficulty swallowing)
研究组 & 干预措施
Modified Atkins Diet (MAD)
A diet that can produce ketones
干预措施: MAD (Dietary Supplement)
MIND diet
Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND). A diet that has been indicated to be helpful in preventing or decreasing cognitive decline.
干预措施: MIND (Dietary Supplement)
结局指标
主要结局
Change in Memory Functioning Questionnaire (MFQ)
时间窗: Baseline/week-0, week-6, completion/week-12
This is a self-report assessment of cognitive decline. It is rated on a 1-7 scale, with 1 indicating "major problems" and 7 indicating "no problems." It includes 8 sections, each including 1-18 sub-questions. It will be assessed by comparing changes in scores between groups and across time (12 weeks).
Change in Loewenstein-Acevedo Scales of Semantic Interference and Learning (LASSI-L)
时间窗: Baseline/week-0, week-6, completion/week-12
This is an assessment of verbal learning and memory for lists of 15 words. More words learned and remembered indicate better learning and memory. It will be assessed by comparing changes in scores between groups and across time (12 weeks).
Change in Para-Rodriguez Short-term Visual Memory Binding Test (SVMBT)
时间窗: Baseline/week-0, week-6, completion/week-12
This is an assessment of visual recognition memory for shapes and colors. More accurate recognition indicates better recognition memory. It will be assessed by comparing changes in scores between groups and across time (12 weeks).
Change in Ketone levels
时间窗: Checked by the participant daily, for 12 weeks/3 months (i.e., from the start day of the diet until the end of the 12 weeks) and checked by the study staff at each study visit (i.e., baseline/week-0, week-3, week-6, and completion/week-12)
This is detected in urine and measured in mg/dL, with higher levels indicating greater production of ketones and greater adherence to the MAD diet. Adherence will be assessed by percent of participants in the MAD group in at least moderate ketosis (\>40 mg/dl) at 3 or more follow-up visits.
MIND Diet Score
时间窗: 12 weeks/3 months (i.e., from the start day of the diet until the end of the 12 weeks)
This is assessed by dietitian review of participants daily food logs. Scores range from 0 (not at all adherent) to 15 (perfectly adherent). Any score greater than 9 is considered adherent. It will be assessed by percent of participants in the MIND group with scores of at least 9 at 3 or more follow-up visits.
ApoE epsilon 4 status
时间窗: Tested via venipuncture or buccal swab at baseline/week-0
This is a genetic marker of Alzheimer's disease risk. It will be coded as positive (one or more epsilon 4 alleles) or negative (no epsilon 4 alleles). It will be evaluated by stratifying the sample by the presence of at least one ε4 allele and conditioning the efficacy analyses by this variable.
次要结局
- Change in Trail Making Test(Baseline, week-6, week-12)
- Change in Prospective Memory Test(Baseline, week-6, week-12)
- Change in Geriatric Anxiety Scale(Baseline, week-6, week-12)
- Change in Geriatric Depression Scale(Baseline, week-6, week-12)