Feasibility and Efficacy of the Ketogenic Diet in Alzheimer's Disease

Not Applicable

Completed

• Conditions: Alzheimer Disease
• Interventions: Behavioral: Ketogenic Diet

• Registration Number: NCT03690193
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

The purpose of the KDRAFT study is to assess the feasibility and preliminary cognitive efficacy of a ketogenic diet therapy in patients with Alzheimer's disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-03
• Primary Completion: 2017-01-06
• Study Completion: 2017-01-06
• Study First Submitted: 2018-08-01
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-27
• Last Update Submitted: 2018-09-27
• Study First Posted: 2018-10-01
• Last Update Posted: 2018-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Alzheimer's disease (CDR 0.5, 1, & 2)
• Active study partner
• BMI > 21
• English speaking

Exclusion Criteria

• BMI < 21
• Consume greater than 14 drinks of alcohol per week
• Insulin Dependent Diabetes Mellitus
• Diagnosis of active cancer
• Myocardial infarction or symptoms of coronary artery disease (e.g. angina) in last year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ketogenic Diet Arm	Ketogenic Diet	All participants will be assigned to the 3-month ketogenic diet intervention. Study partners will be instructed to assist participants in adherence to a 1:1 ketogenic diet (approximately 70% fat, \<10% carbohydrate, and 20% protein). Participants will be provided medium chain triglyceride oil 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.

Primary Outcome Measures

Name	Time	Method
Change in blood ketone levels induced by ketogenic diet	Change from baseline serum beta-hydroxybutyrate levels at month 1, 2, 3 (end of ketogenic diet), and 4 (after 1-month washout).	Serum beta-hydroxybutyrate levels will be measured at five monthly study visits; baseline prior to diet initiation, three monthly collections during the ketogenic diet intervention, and after the 1-month washout return to a regular diet.
Proportion of days positive for urinary ketone production	Daily for 90 days (the length of the diet intervention)	Participants will measure and report daily urinary ketone status using Ketostix (Bayer, Germany).

Secondary Outcome Measures

Name	Time	Method
Dietary intake characterization prior to and after ketogenic diet initiation	Dietary intake will be collected at Baseline, Month 1, Month 2, Month 3	Changes in food and nutrient intake will be assessed by monthly 3-day food records completed by participant study partners.
Change in cognitive performance on the Mini-Mental State Exam (MMSE)	Change from baseline global cognitive scores at month 3 (end of ketogenic diet) and change from month 3 global cognitive scores at month 4 (end of 1-month washout).	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 Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog)	Change from baseline global cognitive scores at month 3 (end of ketogenic diet) and change from month 3 global cognitive scores at month 4 (end of 1-month washout).	Global cognitive performance will be assessed by a psychometrician using the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog). 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.