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Alzheimer's DiseaseMCT-MANCT02709356

Medium Chain Triglycerides and Brain Metabolism in Alzheimer's Disease

A study testing 1-month of 60-40 MCT oil and 1-month of C8 MCT oil in people with Alzheimer's Disease, run by Université de Sherbrooke at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Alzheimer's Disease
What is being tested?
1-month of 60-40 MCT oil and 1-month of C8 MCT oil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
Oct 2015to Feb 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 12Show fewer
  • Clinically-significant renal disease/dysfunction
  • Clinically-significant cardiac disease/conditions
  • Hypertension
  • Uncontrolled dyslipidaemia
  • Vitamin B12 deficiency
  • Structured physical activity (more than 3 times/week)

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

    Sherbrooke, Quebec, J1H4C4

Other trials in Canada

About this study

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

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.

Read the detailed 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.

Being tested
1-month of 60-40 MCT oil, 1-month of C8 MCT oil
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1-month of 60-40 MCT oilDietary supplement

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

  • 1-month of C8 MCT oilDietary supplement

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

Study groups in NCT02709356
Study groupRoleWhat they receive
Alzheimer's diseaseExperimentalPatients 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)
Receives: Dietary Supplement: 1-month of 60-40 MCT oil; Dietary Supplement: 1-month of C8 MCT oil
ControlsExperimentalHealthy elderly people 1-month of 60-40 MCT oil and 1-month of C8 MCT oil (order of the two intervention are randomized)
Receives: Dietary Supplement: 1-month of 60-40 MCT oil; Dietary Supplement: 1-month of C8 MCT oil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quantification of brain glucose uptake

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

    Measured: 1-month

  2. Quantification of brain acetoacetate uptake

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

    Measured: 1-month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2016 (estimated)
  2. Study startOct 2015
  3. Primary completionFeb 2018
  4. Study completionFeb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02709356
Sponsor's protocol ID
2016-547
Acronym
MCT-MA
Status last verified
Dec 2017
First submitted
1 Feb 2016
Last updated
10 Oct 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing 1-month of 60-40 MCT oil and 1-month of C8 MCT oil in people with Alzheimer's Disease, run by Université de Sherbrooke at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quantification of brain glucose uptake (time frame: 1-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02709356.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2018.

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