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

NCT ID: NCT04396015

Last Updated: 2020-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2019-03-31

Brief Summary

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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

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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.

Conditions

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Cognitive Function 1, Social

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

randomized, placebo control cross-over study, with an open label extension
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Double blind placebo controlled

Study Groups

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medium chain triglyceride (MCT) vs placebo

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

Group Type PLACEBO_COMPARATOR

Bulletproof Brain Octane

Intervention Type DIETARY_SUPPLEMENT

Medium chain triglyceride oil (MCT)

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo (olive) oil

open label extension

6 months of MCT oil.

Group Type OTHER

Bulletproof Brain Octane

Intervention Type DIETARY_SUPPLEMENT

Medium chain triglyceride oil (MCT)

Interventions

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Bulletproof Brain Octane

Medium chain triglyceride oil (MCT)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo (olive) oil

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Angela Juby

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Pro00054165

Identifier Type: -

Identifier Source: org_study_id

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