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

University of Kansas

Status: Completed

Conditions: Alzheimer Disease

Treatments: Behavioral: Ketogenic Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03690193

13796

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Ketogenic Diet Arm

Experimental group

Description:

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.

Treatment:

Behavioral: Ketogenic Diet