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

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ketogenic Diet
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Ketogenic Diet, Alzheimer's disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Ketogenic Diet Arm

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Proportion of days positive for urinary ketone production
    Participants will measure and report daily urinary ketone status using Ketostix (Bayer, Germany).
    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.

    Secondary Outcome Measures

    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 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.
    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.

    Full Information

    First Posted
    August 1, 2018
    Last Updated
    September 27, 2018
    Sponsor
    University of Kansas Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03690193
    Brief Title
    Feasibility and Efficacy of the Ketogenic Diet in Alzheimer's Disease
    Acronym
    KDRAFT
    Official Title
    Alzheimer's Disease Ketogenic Diet Retention and Feasibility Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    December 3, 2013 (Actual)
    Primary Completion Date
    January 6, 2017 (Actual)
    Study Completion Date
    January 6, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Kansas Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alzheimer Disease
    Keywords
    Ketogenic Diet, Alzheimer's disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ketogenic Diet Arm
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Ketogenic Diet
    Intervention Description
    All participants will be assigned to the 3-month 1:1 ketogenic diet intervention (approximately 70% fat, <10% carbohydrate, and 20% protein).
    Primary Outcome Measure Information:
    Title
    Proportion of days positive for urinary ketone production
    Description
    Participants will measure and report daily urinary ketone status using Ketostix (Bayer, Germany).
    Time Frame
    Daily for 90 days (the length of the diet intervention)
    Title
    Change in blood ketone levels induced by ketogenic diet
    Description
    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.
    Time Frame
    Change from baseline serum beta-hydroxybutyrate levels at month 1, 2, 3 (end of ketogenic diet), and 4 (after 1-month washout).
    Secondary Outcome Measure Information:
    Title
    Change in cognitive performance on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog)
    Description
    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.
    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).
    Title
    Change in cognitive performance on the Mini-Mental State Exam (MMSE)
    Description
    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.
    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).
    Title
    Dietary intake characterization prior to and after ketogenic diet initiation
    Description
    Changes in food and nutrient intake will be assessed by monthly 3-day food records completed by participant study partners.
    Time Frame
    Dietary intake will be collected at Baseline, Month 1, Month 2, Month 3

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30931426
    Citation
    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.
    Results Reference
    derived

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

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