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

NCT ID: NCT03690193

Last Updated: 2018-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-03
• Study Completion Date: 2017-01-06

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.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ketogenic Diet Arm

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.

Group Type: EXPERIMENTAL

Ketogenic Diet

Intervention Type: BEHAVIORAL

All participants will be assigned to the 3-month 1:1 ketogenic diet intervention (approximately 70% fat, \<10% carbohydrate, and 20% protein).

Interventions

Ketogenic Diet

All participants will be assigned to the 3-month 1:1 ketogenic diet intervention (approximately 70% fat, \<10% carbohydrate, and 20% protein).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Debra K. Sullivan, PhD, RD

Debra K Sullivan, PhD, RD, Chair and Endowed Professor of Clinical Nutrition

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Taylor MK, Swerdlow RH, Burns JM, Sullivan DK. An Experimental Ketogenic Diet for Alzheimer Disease Was Nutritionally Dense and Rich in Vegetables and Avocado. Curr Dev Nutr. 2019 Feb 20;3(4):nzz003. doi: 10.1093/cdn/nzz003. eCollection 2019 Apr.

Reference Type: DERIVED

PMID: 30931426 (View on PubMed)

Other Identifiers

13796

Identifier Type: -

Identifier Source: org_study_id