Feasibility and Efficacy of Dietary Interventions for Older Adults With Subjective Cognitive Decline
2019년 10월 1일 업데이트: Johns Hopkins University
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.
연구 개요
상세 설명
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.
연구 유형
중재적
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
60년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Modified Atkins Diet (MAD)
A diet that can produce ketones
|
A high fat, low carbohydrate diet
|
|
활성 비교기: MIND diet
Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND).
A diet that has been indicated to be helpful in preventing or decreasing cognitive decline.
|
A combination of the Mediterranean and DASH diets
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Memory Functioning Questionnaire (MFQ)
기간: 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).
|
Baseline/week-0, week-6, completion/week-12
|
|
Change in Loewenstein-Acevedo Scales of Semantic Interference and Learning (LASSI-L)
기간: 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).
|
Baseline/week-0, week-6, completion/week-12
|
|
Change in Para-Rodriguez Short-term Visual Memory Binding Test (SVMBT)
기간: 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).
|
Baseline/week-0, week-6, completion/week-12
|
|
Change in Ketone levels
기간: 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.
|
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)
|
|
MIND Diet Score
기간: 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.
|
12 weeks/3 months (i.e., from the start day of the diet until the end of the 12 weeks)
|
|
ApoE epsilon 4 status
기간: 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.
|
Tested via venipuncture or buccal swab at baseline/week-0
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Trail Making Test
기간: Baseline, week-6, week-12
|
This is a timed test of processing speed and executive functioning.
Faster time to completion and fewer errors indicate better processing speed and executive functioning.
It will be assessed by comparing changes in scores between groups and across time (12 weeks).
|
Baseline, week-6, week-12
|
|
Change in Prospective Memory Test
기간: Baseline, week-6, week-12
|
This is a test of remembering to ask that a borrowed item be returned.
The possible scores range from 0 (no cues needed to remember to ask) to 4 (4 cues needed to remember to ask).
More cues required indicates worse prospective memory.
It will be assessed by comparing changes in scores between groups and across time (12 weeks).
|
Baseline, week-6, week-12
|
|
Change in Geriatric Anxiety Scale
기간: Baseline, week-6, week-12
|
This is a self-report measure of symptoms of anxiety in older persons.
It is rated on a 0 (not at all) to 3 (all of the time) scale.
Scores range from 0-90, with higher scores indicating more anxiety.
It will be assessed by comparing changes in scores between groups and across time (12 weeks).
|
Baseline, week-6, week-12
|
|
Change in Geriatric Depression Scale
기간: Baseline, week-6, week-12
|
This is a self-report measure of symptoms of depression in older persons.
Items are rated as yes/no.
Scores range from 0-30, with higher scores indicating more depression.
It will be assessed by comparing changes in scores between groups and across time (12 weeks).
|
Baseline, week-6, week-12
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Cognitive decline concern questionnaire
기간: Baseline, week-6, week-12
|
This is a one question questionnaire that asks how concerned/worried a person is about their subjective cognitive decline on a 1 (majorly worried) to 7 (not at all worried) scale, with higher scores indicating a greater degree of concern/worry.
It will be assessed by comparing changes in scores between groups and across time (12 weeks).
|
Baseline, week-6, week-12
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (예상)
2019년 9월 2일
기본 완료 (예상)
2021년 9월 1일
연구 완료 (예상)
2021년 9월 1일
연구 등록 날짜
최초 제출
2018년 6월 21일
QC 기준을 충족하는 최초 제출
2018년 7월 2일
처음 게시됨 (실제)
2018년 7월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 10월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 10월 1일
마지막으로 확인됨
2019년 10월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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