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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
Sponsor:
Information provided by (Responsible Party):
Debra K. Sullivan, PhD, RD, University of Kansas Medical Center

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
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

Resource links provided by the National Library of Medicine


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).




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.



Information from the National Library of Medicine

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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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     History of Changes
Other Study ID Numbers: 13796
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018

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