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A Medium Chain Triglyceride Intervention for Patients With Alzheimer Disease (MINT-01)

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ClinicalTrials.gov Identifier: NCT02912936
Recruitment Status : Recruiting
First Posted : September 23, 2016
Last Update Posted : December 5, 2018
Sponsor:
Collaborator:
Université de Sherbrooke
Information provided by (Responsible Party):
Haakon Nygaard, University of British Columbia

Brief Summary:
The purpose of this study is to determine safety, tolerability, and pharmacokinetics/dynamics of a ketogenic dietary supplement containing medium chain triglycerides (MCTs) in patients with Alzheimer disease (AD). Novel imaging and laboratory biomarkers in response to this intervention will also be explored.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Dietary Supplement: Ketogenic medium chain triglyceride drink (MCT drink) Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Medium Chain Triglyceride INTervention for Alzheimer Disease (A MINT for AD)
Study Start Date : September 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: Ketogenic medium chain triglyceride drink
Lactose-free skim milk drink containing 25 g of MCT oil per 250 ml.
Dietary Supplement: Ketogenic medium chain triglyceride drink (MCT drink)
10 days supplementation with the MCT drink. Participants in dose group 1 will be assigned to 10 g per day, those in dose group 2 will be assigned 20 g per day, those in dose group 3 will be assigned 30 g per day, those in dose group 4 will be assigned 40 g per day, and those in dose group 5 will be assigned 50 g per day. The drink will be taken in the morning and evening. Participants will be enrolled 8 per group in ascending order.

Placebo Comparator: Placebo
Lactose-free skim milk drink containing high-oleic sunflower oil in the equivalent amount of energy as the active arm.
Dietary Supplement: Placebo
10 days supplementation with the placebo drink. Participants in dose group 1 will be assigned to 10 g per day, those in dose group 2 will be assigned 20 g per day, those in dose group 3 will be assigned 30 g per day, those in dose group 4 will be assigned 40 g per day, and those in dose group 5 will be assigned 50 g per day. The drink will be taken in the morning and evening. Participants will be enrolled 8 per group in ascending order.




Primary Outcome Measures :
  1. Number of participants with adverse events, serious adverse events [ Time Frame: From baseline to day 10 of intervention ]
  2. Plasma ketone concentrations in response to ascending dose of MCT [ Time Frame: Day 10 of intervention at 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, and 6 hours post MCT dose ]
    Plasma ketone concentrations of betahydroxybutyrate (BHB) and acetoacetate (AcAc) will be measured in response to MCT dosing from 10-50 grams daily.


Secondary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC) of MCT [ Time Frame: Day 10 of intervention at 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, and 6 hours post MCT dose ]
    To determine the MCT plasma concentration at stated time points in response to MCT dosing from 10-50 grams daily.


Other Outcome Measures:
  1. Cerebral metabolic rate of glucose in response to a ketogenic MCT drink [ Time Frame: Baseline and day 10 of intervention ]
    Assess changes in metabolic rate of glucose by 18F fludeoxyglucose positron emission tomography (FDG-PET) in response to escalating doses of MCT (10-50grams daily) in patients with Alzheimer's disease

  2. Cerebral blood flow in response to a ketogenic MCT drink [ Time Frame: Baseline and day 10 of intervention ]
    Assess changes in brain blood flow using MRI (Arterial Spin Labeling) in response to escalating doses of MCT (10-50 grams daily) in patients with Alzheimer's disease

  3. Changes in MR Spectroscopy (N-acetylaspartate, glutamate, glutamine) in response to a ketogenic MCT drink [ Time Frame: Baseline and day 10 of intervention ]
    Assess changes in brain chemistry (measuring (N-acetylaspartate, glutamate, glutamine) in response to MCT treatment across a dose range of 10-50grams daily

  4. Changes in daily physical activity in response to a ketogenic MCT drink [ Time Frame: Baseline and day 10 of intervention ]
    Changes in behavior rhythms (activity level and sleep/rest) in response to MCT treatment across a dose range of 10-50grams daily, using an actigraphy watch.



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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of mild-moderate Alzheimer disease (AD)
  • Mini-Mental State Examination (MMSE) 16-26
  • Study partner available who has frequent contact with the participant
  • Good visual and auditory acuity for neuropsychological testing
  • Education including completion of at least six grades
  • Must read and speak English fluently
  • Antidepressants permitted, if stable for 4 weeks prior to screening (and participant is not currently depressed and does not have a history of major depression within the past 1 year)
  • Cholinesterase inhibitors permitted, if stable for 12 weeks prior to screening

Exclusion Criteria:

  • Any significant neurologic disease other than AD
  • History of Diabetes Mellitus type I or II
  • Any contraindications to MRI or PET studies
  • Major depression, bipolar disorder as described within the past 1 year.
  • History of schizophrenia
  • History of alcohol or substance abuse or dependence within the past 2 years
  • Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol
  • Current use of specific psychoactive medications
  • Investigational amyloid lowering therapies are prohibited two months prior to screening and for the duration of the trial. Other investigational agents are prohibited one month prior to screening and for the duration of the trial.
  • History of brain cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912936


Contacts
Contact: Penny Slack, MSc 604-822-6379 pslack@mail.ubc.ca

Locations
Canada, British Columbia
Djavad Mowafaghian Centre for Brain Health Recruiting
Vancouver, British Columbia, Canada, V6T 1Z3
Contact: Penny Slack, MSc    604-822-6379    pslack@mail.ubc.ca   
Principal Investigator: Haakon Nygaard, MD, PhD         
Sponsors and Collaborators
University of British Columbia
Université de Sherbrooke
Investigators
Principal Investigator: Haakon Nygaard, MD, PhD University of British Columbia
Principal Investigator: Howard Feldman, MD University of California, San Diego

Responsible Party: Haakon Nygaard, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02912936     History of Changes
Other Study ID Numbers: H15-02537
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018

Keywords provided by Haakon Nygaard, University of British Columbia:
medium chain triglyceride
MCT
coconut oil
MRI
PET
ketones

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders