Therapeutic Diets in Alzheimer's Disease

Not Applicable

Active, not recruiting

• Conditions: Alzheimer Disease
• Interventions: Behavioral: Ketogenic Diet; Behavioral: Therapeutic Lifestyles Changes Diet

• Registration Number: NCT03860792
• Lead Sponsor: University of Kansas Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-28
• Study First Submitted QC: 2019-02-28
• Study First Posted: 2019-03-04
• Study Start: 2019-10-15
• Status Verified: 2024-11
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-14
• Primary Completion: 2025-05-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketogenic Diet	Ketogenic Diet	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.
Therapeutic Lifestyles Changes Diet	Therapeutic Lifestyles Changes Diet	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.

Primary Outcome Measures

Name	Time	Method
Change in cognitive performance on the Mini-Mental State Exam (MMSE)	Baseline, 12 Weeks	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.
Change in cognitive performance on the Logical Memory Test (LMT)	Baseline, 12 Weeks	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.
Change in cognitive performance by Stroop test	Baseline, 12 Weeks	Reaction time and accuracy will be assessed by a psychometrician using the Stroop test.
Change in cognitive performance on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADASCog11)	Baseline, 12 Weeks	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.
Change in Clinical Dementia Rating (CDR)	Baseline, 12 Weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in self-reported symptoms by study partner	Baseline, 6 Weeks, 12 Weeks	Severity of symptoms will be measured via a self-reported symptoms questionnaire, answered by participant study partners.
Change in cerebral concentration of N-Acetylaspartate (NAA)	Baseline, 12 Weeks	Concentration of cerebral N-Acetylaspartate is measured using magnetic resonance spectroscopy in a 3T clinical scanner.
Change in blood platelet mitochondrial function	Baseline, 6 Weeks, 12 Weeks	Cytochrome c oxidase activity of blood platelets will be determined as a pseudo first order-rate constant (sec-1/mg protein) by measuring the oxidation of reduced cytochrome c at 550 nm.

Trial Locations

Locations (1)

Clinical and Translational Science Unit; 🇺🇸 Fairway, Kansas, United States