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Feasibility and Efficacy of Dietary Interventions for Older Adults With Subjective Cognitive Decline

2019年10月1日 更新者：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.

調査の概要

状態

引きこもった

条件

介入・治療

詳細な説明

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.

研究の種類

介入

段階

  • 適用できない

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

60年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：Modified Atkins Diet (MAD)
A diet that can produce ketones
ダイエットサプリメント：MAD
A high fat, low carbohydrate diet
アクティブコンパレータ：MIND diet
Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND). A diet that has been indicated to be helpful in preventing or decreasing cognitive decline.
ダイエットサプリメント：MIND
A combination of the Mediterranean and DASH diets

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Memory Functioning Questionnaire (MFQ)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Trail Making Test
時間枠：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
時間枠：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
時間枠：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
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Change in Cognitive decline concern questionnaire
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Johns Hopkins University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (予想される)

2019年9月2日

一次修了 (予想される)

2021年9月1日

研究の完了 (予想される)

2021年9月1日

試験登録日

最初に提出

2018年6月21日

QC基準を満たした最初の提出物

2018年7月2日

最初の投稿 (実際)

2018年7月13日

学習記録の更新

投稿された最後の更新 (実際)

2019年10月3日

QC基準を満たした最後の更新が送信されました

2019年10月1日

最終確認日

2019年10月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • IRB00175761

個々の参加者データ (IPD) の計画

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いいえ

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