Dietary Treatments for Cognitive Impairment in Older Adults

NCT ID: NCT02521818

Last Updated: 2019-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2019-07-01

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.

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.

Conditions

Mild Cognitive Impairment; Probable Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Modified Atkins Diet

modified Atkins diet; fewer than 20 mg. carbohydrates per day, supplemented by extra dietary fats

Group Type: EXPERIMENTAL

Modified Atkins Diet

Intervention Type: OTHER

NIA Diet for Seniors

Diet recommended by NIA for seniors

Group Type: ACTIVE_COMPARATOR

NIA Diet for Seniors

Intervention Type: OTHER

Interventions

Modified Atkins Diet

Intervention Type: OTHER

NIA Diet for Seniors

Intervention Type: OTHER

Other Intervention Names

ketogenic diet

Eligibility 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)

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason Brandt, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00066092

Identifier Type: -

Identifier Source: org_study_id