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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04396015
Recruitment Status : Completed
First Posted : May 20, 2020
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
Angela Juby, University of Alberta

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.

Condition or disease Intervention/treatment Phase
Cognitive Function 1, Social Dietary Supplement: Bulletproof Brain Octane Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: randomized, placebo control cross-over study, with an open label extension
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blind placebo controlled
Primary Purpose: Treatment
Official Title: Evaluating Cognitive and Functional Impairment in Alzheimer's Dementia With a Ketogenic Diet.
Actual Study Start Date : March 2016
Actual Primary Completion Date : January 2019
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Placebo Comparator: medium chain triglyceride (MCT) vs placebo
MCT or placebo (olive oil) for 4 months. Crossover at 4 months
Dietary Supplement: Bulletproof Brain Octane
Medium chain triglyceride oil (MCT)

Dietary Supplement: Placebo
Placebo (olive) oil

open label extension
6 months of MCT oil.
Dietary Supplement: Bulletproof Brain Octane
Medium chain triglyceride oil (MCT)




Primary Outcome Measures :
  1. cognition [ Time Frame: 15months ]
    Mini Mental Status Examination (MMSE). 0-30. Higher score with higher cognitive function

  2. Cognition [ Time Frame: 15 months ]
    Montreal Cognitive Assessment (MoCA) 0-30. Higher score with higher cognition

  3. cognition [ Time Frame: 15 months ]
    Cognigram (Cogstate) 0-200. Higher score with higher cognitive function

  4. Behavior [ Time Frame: 15 months ]
    Neuropsychiatric Inventory (NPI) 0-96 Higher score with more behaviour problems

  5. Function [ Time Frame: 15 months ]
    Katz Activities of Daily Living Scale 0-6 Higher score with poorer ADL function


Secondary Outcome Measures :
  1. maximum tolerated daily dose (ml) of MCT oil [ Time Frame: 11 months ]
    tolerability of MCT oil

  2. maximum tolerated daily dose (ml) of placebo (olive) oil [ Time Frame: 4 months ]
    tolerability of placebo oil

  3. Serum cholesterol mmol/l [ Time Frame: 15 months ]
    safety (% change from baseline)

  4. Serum Triglyceride mmol/l [ Time Frame: 15 months ]
    safety (% change from baseline)

  5. Serum Low density lipoprotein (LDL) mmol/l [ Time Frame: 15 months ]
    safety (% change from baseline)

  6. Dual Energy Absorptiometry (DXA) Body fat [ Time Frame: 15 months ]
    safety (% change from baseline)

  7. Incidence of treatment-emergent Adverse events [ Time Frame: 15 months ]
    safety. Mild, moderate or severe events.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: Angela Juby, Professor of Medicine, University of Alberta
ClinicalTrials.gov Identifier: NCT04396015    
Other Study ID Numbers: Pro00054165
First Posted: May 20, 2020    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases