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

Alzheimer Disease Clinical Trial

— KDRAFT  

Official title:

Alzheimer's Disease Ketogenic Diet Retention and Feasibility Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03690193
• Other study ID #: 13796
• Status: Completed
• Phase: N/A
• Start date: December 3, 2013
• Est. completion date: January 6, 2017

Study information

• Verified date: September 2018
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 6, 2017
• Est. primary completion date: January 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of days positive for urinary ketone production	Participants will measure and report daily urinary ketone status using Ketostix (Bayer, Germany).	Daily for 90 days (the length of the diet intervention)
Primary	Change in blood ketone levels induced by ketogenic diet	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.	Change from baseline serum beta-hydroxybutyrate levels at month 1, 2, 3 (end of ketogenic diet), and 4 (after 1-month washout).
Secondary	Change in cognitive performance on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog)	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 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).
Secondary	Change in cognitive performance on the Mini-Mental State Exam (MMSE)	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 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).
Secondary	Dietary intake characterization prior to and after ketogenic diet initiation	Changes in food and nutrient intake will be assessed by monthly 3-day food records completed by participant study partners.	Dietary intake will be collected at Baseline, Month 1, Month 2, Month 3