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

• ClinicalTrials.gov Identifier: NCT03690193
• Recruitment Status: Completed
• First Posted: October 1, 2018
• Last Update Posted: October 1, 2018
• Sponsor: University of Kansas Medical Center
• Information provided by (Responsible Party): Debra K. Sullivan, PhD, RD, University of Kansas Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Alzheimer Disease	Behavioral: Ketogenic Diet	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Alzheimer's Disease Ketogenic Diet Retention and Feasibility Trial
• Actual Study Start Date: December 3, 2013
• Actual Primary Completion Date: January 6, 2017
• Actual Study Completion Date: January 6, 2017

Arms and Interventions

Arm

Intervention/treatment

Experimental: 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.

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

Outcome Measures

Primary Outcome Measures :

1. Proportion of days positive for urinary ketone production [ Time Frame: Daily for 90 days (the length of the diet intervention) ]
   Participants will measure and report daily urinary ketone status using Ketostix (Bayer, Germany).
2. Change in blood ketone levels induced by ketogenic diet [ Time Frame: 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.

Secondary Outcome Measures :

1. Change in cognitive performance on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) [ Time Frame: 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.
2. Change in cognitive performance on the Mini-Mental State Exam (MMSE) [ Time Frame: 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.
3. Dietary intake characterization prior to and after ketogenic diet initiation [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Debra K. Sullivan, PhD, RD, Debra K Sullivan, PhD, RD, Chair and Endowed Professor of Clinical Nutrition, University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT03690193
• Other Study ID Numbers: 13796
• First Posted: October 1, 2018
• Last Update Posted: October 1, 2018
• Last Verified: September 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Debra K. Sullivan, PhD, RD, University of Kansas Medical Center:

Ketogenic Diet; Alzheimer's disease

Additional relevant MeSH terms:

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