Feasibility and Efficacy of the Ketogenic Diet in Alzheimer's Disease (KDRAFT)
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|ClinicalTrials.gov Identifier: NCT03690193|
Recruitment Status : Completed
First Posted : October 1, 2018
Last Update Posted : October 1, 2018
University of Kansas Medical Center
Information provided by (Responsible Party):
Debra K. Sullivan, PhD, RD, University of Kansas Medical Center
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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).
Primary Outcome Measures :
- 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).
- 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 :
- 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.
- 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.
- 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.
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