NCT02709356

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 16, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

October 10, 2018

Status Verified

December 1, 2017

Enrollment Period

2.3 years

First QC Date

February 1, 2016

Last Update Submit

October 9, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • Quantification of brain glucose uptake

    Brain glucose uptake (umol/100g/min) using 18-FDG PET scan

    1-month

  • Quantification of brain acetoacetate uptake

    Brain acetoacetate uptake (umol/100g/min) using 11C-AcAc PET scan

    1-month

Study Arms (2)

Alzheimer's disease

EXPERIMENTAL

Patients with mild Alzheimer's disease. 1-month of 60-40 MCT oil and 1-month of C8 MCT oil (order of the two intervention are randomized)

Dietary Supplement: 1-month of 60-40 MCT oilDietary Supplement: 1-month of C8 MCT oil

Controls

EXPERIMENTAL

Healthy elderly people 1-month of 60-40 MCT oil and 1-month of C8 MCT oil (order of the two intervention are randomized)

Dietary Supplement: 1-month of 60-40 MCT oilDietary Supplement: 1-month of C8 MCT oil

Interventions

1-month of 60-40 MCT oilDIETARY_SUPPLEMENT

1-month supplementation of 30 g MCT oil (60% C10 + 40% C8)/day

Alzheimer's diseaseControls
1-month of C8 MCT oilDIETARY_SUPPLEMENT

1-month supplementation of 30 g MCT oil (100% C8)/day (1-month of C8 MCT oïl)

Alzheimer's diseaseControls

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)

Sherbrooke, Quebec, J1H4C4, Canada

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Stephen Cunnane, PhD

    Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS) - Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2016

First Posted

March 16, 2016

Study Start

October 1, 2015

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

October 10, 2018

Record last verified: 2017-12

Locations