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Dietary Treatments for Cognitive Impairment in Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02521818
Recruitment Status : Completed
First Posted : August 13, 2015
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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Brief Summary:
This trial seeks to establish the feasibility of implementing a ketogenic, modified Atkins diet (MAD) to older adults with mild cognitive impairment (MCI) or early Alzheimer's disease (AD) living in the community. A secondary aim is to determine whether adherence to the MAD results in better cognitive test scores than adherence to a non-ketogenic control diet. A final aim is to determine the role of apolipoprotein E (ApoE) genotype in participants' response to the MAD. Participants will be randomly assigned to a 12-week trial of either the MAD or a placebo diet based on the National Institute on Aging's recommendations for senior nutrition.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Probable Alzheimer's Disease Other: Modified Atkins Diet Other: NIA Diet for Seniors Not Applicable

Detailed Description:

It is well established that Alzheimer's disease (AD) is associated with insulin resistance and, hence, abnormal glucose metabolism. In fact, abnormalities in the brain's uptake of glucose can be observed on PET imaging in advance of clinical symptoms. In patients with established dementia due to AD, the severity of cognitive impairment is strongly correlated with the decrease in glucose uptake. Ketone bodies, the products of fat metabolism, can serve as a "backup" fuel when glucose is unavailable. Ketone body metabolism appears to bypass the metabolic processes that are abnormal in AD and may provide better nourishment for neurons. As a result, ketone body metabolism may slow cognitive decline or even improve cognition in patients with AD.

Participants will be 60 people, age 60 or older, with MCI or mild probable AD and without significant cardiovascular disease. They will be required to obtain the consent of their primary care physicians for their participation. Each patient will have a study partner who is cognitively healthy, lives with the participant, and can help him/her adhere to the diet. A research dietitian will teach participants and partners the new diet and monitor participants' adherence with food logs, in-person assessments, and urine ketone testing. After an initial baseline visit, participants will complete four in-person assessments during which adherence to the diet will be assessed and neurocognitive tests will be administered. It is hypothesized that the MAD will be feasible and well tolerated by seniors with MCI and AD. It is further hypothesized that adherence to the MAD will be associated with a greater increase (or less decline) in cognitive test scores than the placebo diet, particularly for those participants who do not carry an ApoE ε4 allele.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Feasibility and Efficacy of Dietary Interventions for Cognitive Impairment in Older Adults
Actual Study Start Date : August 2015
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Modified Atkins Diet
modified Atkins diet; fewer than 20 mg. carbohydrates per day, supplemented by extra dietary fats
 Other: Modified Atkins Diet
Other Name: ketogenic diet
Active Comparator: NIA Diet for Seniors
Diet recommended by NIA for seniors
 Other: NIA Diet for Seniors


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility for MAD Group [ Time Frame: 12 weeks ]
    Achieving moderate ketosis (>=40 mg.dl) at 3 consecutive follow-up visits

  2. Feasibility for Control Group [ Time Frame: 12 weeks ]
    Achieving a Healthy Eating Index (>=85) at 3 consecutive follow-up visits


Secondary Outcome Measures :
  1. Efficacy for Cognition [ Time Frame: 12 weeks ]
    Composite Memory Score (mean z-score on delayed recall of HVLT-R and BVMT-R)

  2. Efficacy for Function [ Time Frame: 12 weeks ]
    Change in MDS-HC Instrumental Activities of Daily Living Score


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of mild cognitive impairment or Alzheimer's disease
  • availability of cohabitating study partner without cognitive impairment
  • consent of primary care physician

Exclusion Criteria:

  • history of stroke
  • history of coronary artery disease
  • history of pancreatitis
  • untreated hypothyroidism or B12 deficiency
  • history of renal disease or recurrent kidney stones
  • history of liver disease
  • insulin-dependent diabetes
  • body mass index <18.5
  • multiple food allergies
  • follow strict diet (e.g., vegetarian, gluten-free)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02521818


Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Jason Brandt, Ph.D. Johns Hopkins University
More Information
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02521818    
Other Study ID Numbers: IRB00066092
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Keywords provided by Johns Hopkins University:
cognition
dementia
neuropsychological
 elderly
nutrition
diet
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders