Dietary Treatments for Cognitive Impairment in Older Adults

NCT02521818 | Completed

• 1 other identifier: IRB00066092
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Probable Alzheimer's Disease

Keywords

cognition; dementia; neuropsychological; elderly; nutrition; diet

Outcome Measures

Primary Outcomes (2)

• Feasibility for MAD Group

  Achieving moderate ketosis (\>=40 mg.dl) at 3 consecutive follow-up visits

  12 weeks

• Feasibility for Control Group

  Achieving a Healthy Eating Index (\>=85) at 3 consecutive follow-up visits

  12 weeks

Secondary Outcomes (2)

• Efficacy for Cognition

  12 weeks

• Efficacy for Function

  12 weeks

Study Arms (2)

Modified Atkins Diet

EXPERIMENTAL

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

Other: Modified Atkins Diet

NIA Diet for Seniors

ACTIVE COMPARATOR

Diet recommended by NIA for seniors

Other: NIA Diet for Seniors

Interventions

Modified Atkins Diet OTHER

Also known as: ketogenic diet

Modified Atkins Diet

NIA Diet for Seniors OTHER

NIA Diet for Seniors

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Jason Brandt, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: August 13, 2015
• Study Start: August 1, 2015
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: September 6, 2019

Record last verified: 2019-09

Locations

US (1)