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

Primary Purpose

Alzheimer's Disease

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ketogenic medium chain triglyceride drink (MCT drink)
Placebo
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring medium chain triglyceride, MCT, coconut oil, MRI, PET, ketones

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Djavad Mowafaghian Centre for Brain HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ketogenic medium chain triglyceride drink

Placebo

Arm Description

Lactose-free skim milk drink containing 25 g of MCT oil per 250 ml.

Lactose-free skim milk drink containing high-oleic sunflower oil in the equivalent amount of energy as the active arm.

Outcomes

Primary Outcome Measures

Number of participants with adverse events, serious adverse events
Plasma ketone concentrations in response to ascending dose of MCT
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

Area under the plasma concentration versus time curve (AUC) of MCT
To determine the MCT plasma concentration at stated time points in response to MCT dosing from 10-50 grams daily.

Full Information

First Posted
July 13, 2016
Last Updated
December 3, 2018
Sponsor
University of British Columbia
Collaborators
Université de Sherbrooke
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1. Study Identification

Unique Protocol Identification Number
NCT02912936
Brief Title
A Medium Chain Triglyceride Intervention for Patients With Alzheimer Disease
Acronym
MINT-01
Official Title
A Medium Chain Triglyceride INTervention for Alzheimer Disease (A MINT for AD)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Université de Sherbrooke

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
medium chain triglyceride, MCT, coconut oil, MRI, PET, ketones

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketogenic medium chain triglyceride drink
Arm Type
Experimental
Arm Description
Lactose-free skim milk drink containing 25 g of MCT oil per 250 ml.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Lactose-free skim milk drink containing high-oleic sunflower oil in the equivalent amount of energy as the active arm.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketogenic medium chain triglyceride drink (MCT drink)
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Number of participants with adverse events, serious adverse events
Time Frame
From baseline to day 10 of intervention
Title
Plasma ketone concentrations in response to ascending dose of MCT
Description
Plasma ketone concentrations of betahydroxybutyrate (BHB) and acetoacetate (AcAc) will be measured in response to MCT dosing from 10-50 grams daily.
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
Secondary Outcome Measure Information:
Title
Area under the plasma concentration versus time curve (AUC) of MCT
Description
To determine the MCT plasma concentration at stated time points in response to MCT dosing from 10-50 grams daily.
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
Other Pre-specified Outcome Measures:
Title
Cerebral metabolic rate of glucose in response to a ketogenic MCT drink
Description
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
Time Frame
Baseline and day 10 of intervention
Title
Cerebral blood flow in response to a ketogenic MCT drink
Description
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
Time Frame
Baseline and day 10 of intervention
Title
Changes in MR Spectroscopy (N-acetylaspartate, glutamate, glutamine) in response to a ketogenic MCT drink
Description
Assess changes in brain chemistry (measuring (N-acetylaspartate, glutamate, glutamine) in response to MCT treatment across a dose range of 10-50grams daily
Time Frame
Baseline and day 10 of intervention
Title
Changes in daily physical activity in response to a ketogenic MCT drink
Description
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.
Time Frame
Baseline and day 10 of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Penny Slack, MSc
Phone
604-822-6379
Email
pslack@mail.ubc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haakon Nygaard, MD, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Howard Feldman, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Djavad Mowafaghian Centre for Brain Health
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Penny Slack, MSc
Phone
604-822-6379
Email
pslack@mail.ubc.ca
First Name & Middle Initial & Last Name & Degree
Haakon Nygaard, MD, PhD

12. IPD Sharing Statement

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A Medium Chain Triglyceride Intervention for Patients With Alzheimer Disease

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