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

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Function 1, Social
• Intervention / Treatment: Dietary supplement: Bulletproof Brain Octane; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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
Other: open label extension; 6 months of MCT oil.	Dietary supplement: Bulletproof Brain Octane; Medium chain triglyceride oil (MCT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cognition	Mini Mental Status Examination (MMSE). 0-30. Higher score with higher cognitive function	15months
Cognition	Montreal Cognitive Assessment (MoCA) 0-30. Higher score with higher cognition	15 months
cognition	Cognigram (Cogstate) 0-200. Higher score with higher cognitive function	15 months
Behavior	Neuropsychiatric Inventory (NPI) 0-96 Higher score with more behaviour problems	15 months
Function	Katz Activities of Daily Living Scale 0-6 Higher score with poorer ADL function	15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maximum tolerated daily dose (ml) of MCT oil	tolerability of MCT oil	11 months
maximum tolerated daily dose (ml) of placebo (olive) oil	tolerability of placebo oil	4 months
Serum cholesterol mmol/l	safety (% change from baseline)	15 months
Serum Triglyceride mmol/l	safety (% change from baseline)	15 months
Serum Low density lipoprotein (LDL) mmol/l	safety (% change from baseline)	15 months
Dual Energy Absorptiometry (DXA) Body fat	safety (% change from baseline)	15 months
Incidence of treatment-emergent Adverse events	safety. Mild, moderate or severe events.	15 months

Collaborators and Investigators

• Sponsor: University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: October 5, 2017
• First Submitted That Met QC Criteria: May 15, 2020
• First Posted (Actual): May 20, 2020

Study Record Updates

• Last Update Posted (Actual): May 20, 2020
• Last Update Submitted That Met QC Criteria: May 15, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: Pro00054165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No