Therapeutic Diets in Alzheimer's Disease

NCT03860792 | Completed DMC

• 1 other identifier: STUDY00143457
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

By doing this study, researchers hope to learn how the ketogenic and Therapeutic Lifestyles Changes diets affect cognition in patients with Alzheimer's disease.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (5)

• Change in cognitive performance on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADASCog11)

  Cognitive performance will be assessed by a psychometrician using the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADASCog11). The ADAS-Cog is an Alzheimer's disease specific, multi-domain cognitive assessment scored from 0-70 points with higher scores indicating poorer cognitive performance.

  Baseline, 12 Weeks

• Change in cognitive performance on the Mini-Mental State Exam (MMSE)

  Global cognitive performance will be assessed by a psychometrician using the Mini-Mental State Exam (MMSE). The MMSE is a brief cognitive questionnaire with a maximum score of 30 points where higher scores indicate better cognitive performance.

  Baseline, 12 Weeks

• Change in cognitive performance on the Logical Memory Test (LMT)

  The Logical Memory, subtest of the WMS-R is a standardized assessment of narrative episodic memory. A short story is orally presented, and the examinee is asked to recall the story immediately.

  Baseline, 12 Weeks

• Change in cognitive performance by Stroop test

  Reaction time and accuracy will be assessed by a psychometrician using the Stroop test.

  Baseline, 12 Weeks

• Change in Clinical Dementia Rating (CDR)

  The Clinical Dementia Rating is a 5-point scale (CDR 0, 0.5, 1, 2, and 3) used to characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias. CDR 0 indicates no dementia and higher values indicate more severe dementia. The scores of all six domains are averaged to form a global CDR score. Change in score from baseline to 3 months will be assessed.

  Baseline, 12 Weeks

Secondary Outcomes (3)

• Change in cerebral concentration of N-Acetylaspartate (NAA)

  Baseline, 12 Weeks

• Change in blood platelet mitochondrial function

  Baseline, 6 Weeks, 12 Weeks

• Change in self-reported symptoms by study partner

  Baseline, 6 Weeks, 12 Weeks

Other Outcomes (3)

• Change in blood ketone levels induced by ketogenic diet

  Baseline, 6 Weeks, 12 Weeks

• Proportion of days positive for urinary ketone production

  Daily for 90 days (the length of the diet intervention)

• Dietary intake characterization prior to and after ketogenic diet initiation

  Baseline, 6 Weeks, 12 Weeks

Study Arms (2)

Ketogenic Diet

EXPERIMENTAL

Study partners will be instructed to assist participants in adherence to a 1:1 ketogenic diet (approximately 70% fat, \<10% carbohydrate, and 20% protein as energy). The diet will encourage ≥4 servings of non-starchy vegetables and 1/2 cup of berries daily. Participants will be provided an emulsified medium chain triglyceride supplement with a target intake of 1-2 tablespoons per day and micronutrient supplements consisting of multivitamin, vitamin D, calcium, and phosphorus. After the 3-month ketogenic diet, participants will complete a 1-month washout period in which they halt adherence to the ketogenic diet and resume their normal diet.

Behavioral: Ketogenic Diet

Therapeutic Lifestyles Changes Diet

ACTIVE COMPARATOR

Study partners will be instructed to assist participants in adherence to the Therapeutic Lifestyles Changes diet. The diet consists of 20-35% fat, 50-60% carbohydrate, and \~15% protein as energy. Fat intake will comprise \<7% saturated fat, ≤20% monounsaturated fat, and ≤10% polyunsaturated fat as total energy. Cholesterol consumption will be ≤200mg per day. Participants are encouraged to eat ≥2 servings of fruit and ≥5 servings of vegetables per day.

Behavioral: Therapeutic Lifestyles Changes Diet

Interventions

Ketogenic Diet BEHAVIORAL

Three-month 1:1 ketogenic diet intervention (approximately 70% fat, \<10% carbohydrate, and 20% protein).

Ketogenic Diet

Therapeutic Lifestyles Changes Diet BEHAVIORAL

Three-month diet intervention that is low in fat and cholesterol, high in fruits, vegetables, and whole grains, and moderate in protein.

Therapeutic Lifestyles Changes Diet

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of AD by current McKhann et al. criteria
• CDR global score of 0.5 or 1
• Agreed cooperation from an appropriate study partner
• Speaks English as primary language
• Age 50 to 90
• No medication changes within the past 30 days

You may not qualify if:

• Resides in a nursing home or dementia special care unit, or cannot control diet
• A potentially confounding serious medical risk including insulin-requiring diabetes, cancer requiring chemotherapy or radiation within the past 5 years, or a recent cardiac event (i.e. heart attack, angioplasty, etc.)
• Participating in another clinical trial or using an investigational drug or therapy within 30 days of the Screening Visit
• A history of renal stones

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Clinical and Translational Science Unit

Fairway, Kansas, 66205, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All outcomes assessors are masked from participant group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 4, 2019
• Study Start: October 15, 2019
• Primary Completion: May 23, 2025
• Study Completion: June 20, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)