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

University of Alberta

Status: Completed

Conditions: Cognitive Function 1, Social

Treatments: Dietary Supplement: Bulletproof Brain Octane; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04396015

Pro00054165

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

medium chain triglyceride (MCT) vs placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Bulletproof Brain Octane

open label extension

Other group

Description:

6 months of MCT oil.

Treatment:

Dietary Supplement: Bulletproof Brain Octane