Medium Chain Triglycerides and Brain Metabolism in Alzheimer's Disease

Alzheimer's Disease Clinical Trial

— MCT-MA  

Official title:

Proof of Concepts: Can a Supplement Ketogenic Based MCT Oil Increases Cerebral Capture Ketones in People With Alzheimer's Disease?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02709356
• Other study ID #: 2016-547
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: February 2018

Study information

• Verified date: December 2017
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate and compare the changes in brain ketone and glucose uptake after taking two different MCT oil emulsions (60-40 oil or C8 oil) for one month, in a group of people with Alzheimer's disease and a control group.

Description:

Based on a PET/MRI protocol, the aim of this study is to evaluate and compare the response to the dietary supplementation of two different MCT oils (60% C10 + 40% C8 or 100 % C8) in two groups, patients with Alzheimer's disease and healthy elderly people (N=10/group). After a baseline evaluation, participant will test one of the supplements during two successive periods of one month; each period of time ending with 18F-FDG and 11C-acetoacetate PET scans.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Good general health for Control group

• Diagnosis of Alzheimer's disease (NINCDS-ADRDA criteria) for AD group

Exclusion Criteria:

• Depression

• Medical or psychiatric conditions that could interfere with study participation

• Fasting plasma glucose =7.0 mM (diabetes or prediabetes)

• Already on MCT supplementation

• Clinically-significant gastrointestinal disease/conditions

• Clinically-significant liver disease/dysfunction

• Clinically-significant renal disease/dysfunction

• Clinically-significant cardiac disease/conditions

• Hypertension

• Uncontrolled dyslipidaemia

• Vitamin B12 deficiency

• Structured physical activity (more than 3 times/week)

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Dietary Supplement:
• 1-month of 60-40 MCT oil
1-month supplementation of 30 g MCT oil (60% C10 + 40% C8)/day
• 1-month of C8 MCT oil
1-month supplementation of 30 g MCT oil (100% C8)/day (1-month of C8 MCT oïl)

Locations

Country	Name	City	State
Canada	Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	Fondation Vitae

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantification of brain glucose uptake	Brain glucose uptake (umol/100g/min) using 18-FDG PET scan	1-month
Primary	Quantification of brain acetoacetate uptake	Brain acetoacetate uptake (umol/100g/min) using 11C-AcAc PET scan	1-month