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Mild Cognitive ImpairmentBENEFICNCT02551419

Proof of Mechanism of a New Ketogenic Supplement Using Dual Tracer PET (Positron Emission Tomography)

A study testing ketogenic drink in people with Mild Cognitive Impairment, 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

A six month, placebo-controlled, parallel group project in which MCI participants will receive 30 g/day of a custom-made MCT-based ketogenic supplement or a matching placebo. Uptake of both the brain's fuels - ketones (as 11C-AcAc) and glucose (as FDG) - both before and after the intervention will be assessed by PET… Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
ketogenic drink
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
82 participants
Where
1 siteCanada
Study dates
Jun 2015to Dec 2019
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 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • subjective memory complaint
  • Montreal Cognitive Assessment (MoCA) score of 18-26/30 or a Mini-mental state exam (MMSE) score of 24-27/30
  • autonomy for activity of daily living
  • absence of depression

Who cannot join

  • diagnosis of a major cognitive disorder
  • diseases or psychiatric disorders that could interfere with participation
  • uncontrolled diabetes (fasting plasma glucose >7 mM or glycated hemoglobin >6.5%)
  • major depression or history of alcohol or substance abuse within the past 2 years,
  • already supplementing with coconut oil or MCT
  • vitamin B12 deficiency
Show all 11Show fewer
  • uncontrolled hypertension, dyslipidemia, or thyroid disease,
  • visual or hearing impairment impeding comprehension
  • participation in another intervention trial
  • inability to lie down without moving for 60 min (for the brain imaging)
  • presence of implanted metal objects or devices contraindicated for MRI (phase 1)

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Research Center on Aging

    Sherbrooke, Quebec, J1H 4C4

Other trials in Canada

About this study

Official title: Effect of a Ketogenic Supplement on Brain Energy Metabolism Measured by Neuroimaging in Mild Cognitive Impairment

A six month, placebo-controlled, parallel group project in which MCI participants will receive 30 g/day of a custom-made MCT-based ketogenic supplement or a matching placebo. Uptake of both the brain's fuels - ketones (as 11C-AcAc) and glucose (as FDG) - both before and after the intervention will be assessed by PET (position emission tomography) ; imaging and ketone pharmacokinetic as primary objective as well as fMRI, diffusion MRI and cognition.

Being tested
ketogenic drink, placebo
Keywords
mild cognitive impairment, ketones, medium chain triglycerides, Positron emission tomography, magnetic resonance imaging, cognition, brain, neuroimaging
Medical subject headings
Cognitive Dysfunction, Ketosis

What participants receive

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

  • ketogenic drinkDietary supplement

    6 months' supplementation with the ketogenic drink . Product will be taken daily - 125 ml will be consumed at the morning meal, and 125 ml at the evening meal.

  • placeboDietary supplement

    6 months' supplementation with the placebo drink . Product will be taken daily - 125 ml will be consumed at the morning meal, and 125 ml at the

Study groups in NCT02551419
Study groupRoleWhat they receive
ketogenic drinkExperimentalMCT ketogenic drink: ketogenic drink providing 30 g/d of MCT oil in 250 ml of lactose-free skim milk for 6 months supplementation
Receives: Dietary Supplement: ketogenic drink
PlaceboPlacebo comparatorLactose-free skim milk-based placebo drink containing high-oleic sunflower oil of equivalent energy value to the active arm for a 6 months supplementation
Receives: Dietary Supplement: placebo

What is being measured

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

  1. Change in global ketone (11C-AcAc) uptake in grey matter

    The change in brain ketone uptake will be quantified by PET and expressed as cerebral metabolic rate of AcAc (CMR-A)

    Measured: Baseline and 6 months of intervention

  2. Change in plasma ketone

    The change in plasma ketone will be measure to obtain a ketone chronic response

    Measured: Baseline and 6 months of intervention

Secondary outcomes (12)

  1. Change in global brain FDG uptake in grey matter (CMR-G)

    The change in brain glucose uptake will be quantified by PET and expressed as cerebral metabolic rate of glucose (CMR-G)

    Measured: Baseline and 6 months of intervention

  2. Change in regional CMR-A

    The change in brain ketone uptake will be quantified by PET in different regions of the brain

    Measured: Baseline and 6 months of intervention

  3. regional brain volumes by vMRI

    Change in brain volume measure by MRI

    Measured: Baseline and 6 months of intervention

  4. Change in cognitive status - episodic memory

    Change in episodic memory assessed by the 16-item free/cued word learning (Buschke and Grober test- Z score of trial 1, 2, 3 and delay) and the Brief Visuospatial Memory Test-revised (Z score of trial 1)

    Measured: Baseline and 6 months of intervention

  5. Change in cognitive status- language domain

    Change in language assessed by Boston Naming Test (Z score)

    Measured: Baseline and 6 months of intervention

  6. Change in cognitive status - executive function

    Change in executive function assessed by condition 4 of the trail making test, condition 3 and 4 of the Stroop test and the 4 conditions of verbal fluency test (all Z score)

    Measured: Baseline and 6 months of intervention

  7. Change in cognitive status - processing speed

    Change in processing speed assessed by global score of Digit Span (WAIS III), Digit Symbol (WAIS III), condition 1 and 2 of Stroop test and condition 1,2,3,5 of the trail making test (all Z score)

    Measured: Baseline and 6 months of intervention

  8. Blood metabolite profile triglycerides

    Changes in Triglycerides (mM)

    Measured: Baseline and 6 months of intervention

  9. Blood metabolite profile Glucose

    Changes in Glucose (mM)

    Measured: Baseline and 6 months of intervention

  10. Blood metabolite profile cholesterol

    Changes in Total cholesterol (mM)

    Measured: Baseline and 6 months of intervention

  11. Derived cerebral metabolic rate of total ketones

    Cerebral metabolic rate of total ketone derived from ketone PET (dCMRket, μmol/100 g/min)

    Measured: Baseline and 6 months of intervention

  12. Pharmacokinetic ketone response (phase 2)

    Area under the curve of pharmacokinetic of blood ketone

    Measured: Baseline and 6 months of intervention

Timeline

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

  1. First posted16 Sep 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionDec 2019
  4. Study completionDec 2019

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02551419
Sponsor's protocol ID
2015-509
Acronym
BENEFIC
Status last verified
Nov 2019
First submitted
15 Sep 2015
Last updated
26 Mar 2020
Results posted
No
Data monitoring committee
No

Publications

  • Castellano CA, Nugent S, Paquet N, Tremblay S, Bocti C, Lacombe G, Imbeault H, Turcotte E, Fulop T, Cunnane SC. Lower brain 18F-fluorodeoxyglucose uptake but normal 11C-acetoacetate metabolism in mild Alzheimer's disease dementia. J Alzheimers Dis. 2015;43(4):1343-53. doi: 10.3233/JAD-141074.

    PubMed 25147107

  • Nugent S, Castellano CA, Goffaux P, Whittingstall K, Lepage M, Paquet N, Bocti C, Fulop T, Cunnane SC. Glucose hypometabolism is highly localized, but lower cortical thickness and brain atrophy are widespread in cognitively normal older adults. Am J Physiol Endocrinol Metab. 2014 Jun 1;306(11):E1315-21. doi: 10.1152/ajpendo.00067.2014. Epub 2014 Apr 15.

    PubMed 24735889

  • Nugent S, Tremblay S, Chen KW, Ayutyanont N, Roontiva A, Castellano CA, Fortier M, Roy M, Courchesne-Loyer A, Bocti C, Lepage M, Turcotte E, Fulop T, Reiman EM, Cunnane SC. Brain glucose and acetoacetate metabolism: a comparison of young and older adults. Neurobiol Aging. 2014 Jun;35(6):1386-95. doi: 10.1016/j.neurobiolaging.2013.11.027. Epub 2013 Dec 1.

    PubMed 24388785

  • Courchesne-Loyer A, Fortier M, Tremblay-Mercier J, Chouinard-Watkins R, Roy M, Nugent S, Castellano CA, Cunnane SC. Stimulation of mild, sustained ketonemia by medium-chain triacylglycerols in healthy humans: estimated potential contribution to brain energy metabolism. Nutrition. 2013 Apr;29(4):635-40. doi: 10.1016/j.nut.2012.09.009. Epub 2012 Dec 28.

    PubMed 23274095

  • Cunnane S, Nugent S, Roy M, Courchesne-Loyer A, Croteau E, Tremblay S, Castellano A, Pifferi F, Bocti C, Paquet N, Begdouri H, Bentourkia M, Turcotte E, Allard M, Barberger-Gateau P, Fulop T, Rapoport SI. Brain fuel metabolism, aging, and Alzheimer's disease. Nutrition. 2011 Jan;27(1):3-20. doi: 10.1016/j.nut.2010.07.021. Epub 2010 Oct 29.

    PubMed 21035308

Questions about this trial

What is this clinical trial studying?

A study testing ketogenic drink in people with Mild Cognitive Impairment, 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 4 inclusion and 11 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 26 Mar 2020. 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. Some participants in this study may receive a placebo. 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?

Change in global ketone (11C-AcAc) uptake in grey matter (time frame: Baseline and 6 months of intervention). 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 NCT02551419, which also lists 5 linked publications.

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 26 Mar 2020.

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