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Evaluating Cognitive and Functional Impairment in Alzheimer's Dementia With a Ketogenic Diet.

Primary Purpose

Cognitive Function 1, Social

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bulletproof Brain Octane
Placebo
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Function 1, Social

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients >49years with a clinical diagnosis of AD
  • Mini Mental Status Examination (MMSE) score 10-29/30
  • on stable dose of medications for 3 months (AChEI, memantine and antidepressants allowed)
  • able to speak English
  • patient or designate able to sign informed consent
  • stable chronic medical conditions (Heart disease, thyroid disease)
  • reliable caregiver

Exclusion Criteria:

  • age <50 years
  • medically unstable
  • unable to swallow liquids
  • diagnosis of diabetes mellitus
  • residence in a nursing/long term care home
  • allergy to coconut
  • allergy to olive oil

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Other

    Arm Label

    medium chain triglyceride (MCT) vs placebo

    open label extension

    Arm Description

    MCT or placebo (olive oil) for 4 months. Crossover at 4 months

    6 months of MCT oil.

    Outcomes

    Primary Outcome Measures

    cognition
    Mini Mental Status Examination (MMSE). 0-30. Higher score with higher cognitive function
    Cognition
    Montreal Cognitive Assessment (MoCA) 0-30. Higher score with higher cognition
    cognition
    Cognigram (Cogstate) 0-200. Higher score with higher cognitive function
    Behavior
    Neuropsychiatric Inventory (NPI) 0-96 Higher score with more behaviour problems
    Function
    Katz Activities of Daily Living Scale 0-6 Higher score with poorer ADL function

    Secondary Outcome Measures

    maximum tolerated daily dose (ml) of MCT oil
    tolerability of MCT oil
    maximum tolerated daily dose (ml) of placebo (olive) oil
    tolerability of placebo oil
    Serum cholesterol mmol/l
    safety (% change from baseline)
    Serum Triglyceride mmol/l
    safety (% change from baseline)
    Serum Low density lipoprotein (LDL) mmol/l
    safety (% change from baseline)
    Dual Energy Absorptiometry (DXA) Body fat
    safety (% change from baseline)
    Incidence of treatment-emergent Adverse events
    safety. Mild, moderate or severe events.

    Full Information

    First Posted
    October 5, 2017
    Last Updated
    May 15, 2020
    Sponsor
    University of Alberta
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04396015
    Brief Title
    Evaluating Cognitive and Functional Impairment in Alzheimer's Dementia With a Ketogenic Diet.
    Official Title
    Evaluating Cognitive and Functional Impairment in Alzheimer's Dementia With a Ketogenic Diet.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2016 (Actual)
    Primary Completion Date
    January 2019 (Actual)
    Study Completion Date
    March 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alberta

    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 present study is being done in a scientifically rigorous manner, using readily available MCT oil (refined from coconut oil) versus a placebo oil to assess any cognitive and functional benefits for AD patients.
    Detailed Description
    The proposed study, is a randomized placebo controlled cross-over study for 6 months, with an open label extension for another 6 months designed to test the benefits and safety of MCT oil in patients with established AD. It will be the first study on MCT oil ever done with this design, and for this duration in AD.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cognitive Function 1, Social

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    randomized, placebo control cross-over study, with an open label extension
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Double blind placebo controlled
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    medium chain triglyceride (MCT) vs placebo
    Arm Type
    Placebo Comparator
    Arm Description
    MCT or placebo (olive oil) for 4 months. Crossover at 4 months
    Arm Title
    open label extension
    Arm Type
    Other
    Arm Description
    6 months of MCT oil.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Bulletproof Brain Octane
    Intervention Description
    Medium chain triglyceride oil (MCT)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo (olive) oil
    Primary Outcome Measure Information:
    Title
    cognition
    Description
    Mini Mental Status Examination (MMSE). 0-30. Higher score with higher cognitive function
    Time Frame
    15months
    Title
    Cognition
    Description
    Montreal Cognitive Assessment (MoCA) 0-30. Higher score with higher cognition
    Time Frame
    15 months
    Title
    cognition
    Description
    Cognigram (Cogstate) 0-200. Higher score with higher cognitive function
    Time Frame
    15 months
    Title
    Behavior
    Description
    Neuropsychiatric Inventory (NPI) 0-96 Higher score with more behaviour problems
    Time Frame
    15 months
    Title
    Function
    Description
    Katz Activities of Daily Living Scale 0-6 Higher score with poorer ADL function
    Time Frame
    15 months
    Secondary Outcome Measure Information:
    Title
    maximum tolerated daily dose (ml) of MCT oil
    Description
    tolerability of MCT oil
    Time Frame
    11 months
    Title
    maximum tolerated daily dose (ml) of placebo (olive) oil
    Description
    tolerability of placebo oil
    Time Frame
    4 months
    Title
    Serum cholesterol mmol/l
    Description
    safety (% change from baseline)
    Time Frame
    15 months
    Title
    Serum Triglyceride mmol/l
    Description
    safety (% change from baseline)
    Time Frame
    15 months
    Title
    Serum Low density lipoprotein (LDL) mmol/l
    Description
    safety (% change from baseline)
    Time Frame
    15 months
    Title
    Dual Energy Absorptiometry (DXA) Body fat
    Description
    safety (% change from baseline)
    Time Frame
    15 months
    Title
    Incidence of treatment-emergent Adverse events
    Description
    safety. Mild, moderate or severe events.
    Time Frame
    15 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients >49years with a clinical diagnosis of AD Mini Mental Status Examination (MMSE) score 10-29/30 on stable dose of medications for 3 months (AChEI, memantine and antidepressants allowed) able to speak English patient or designate able to sign informed consent stable chronic medical conditions (Heart disease, thyroid disease) reliable caregiver Exclusion Criteria: age <50 years medically unstable unable to swallow liquids diagnosis of diabetes mellitus residence in a nursing/long term care home allergy to coconut allergy to olive oil

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Evaluating Cognitive and Functional Impairment in Alzheimer's Dementia With a Ketogenic Diet.

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