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Completed

NCT Number: NCT03690193

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketogenic diet

Behavioral

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

Alzheimer's Disease Ketogenic Diet Retention and Feasibility Trial

Acronym: KDRAFT

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Oct 1, 2018
Registry last updated
Oct 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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