Cognitive Function 1, SocialNCT04396015
Evaluating Cognitive and Functional Impairment in Alzheimer's Dementia With a Ketogenic Diet.
A study testing Bulletproof Brain Octane in people with Cognitive Function 1, Social, run by University of Alberta.
Trial summary
The present study is being done in a scientifically rigorous manner, using readily available MCT oil (refined from coconut oil) versus a placebo oil to assess any cognitive and functional benefits for AD patients. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Cognitive Function 1, Social
- What is being tested?
- Bulletproof Brain Octane
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Mar 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients >49years with a clinical diagnosis of AD
- Mini Mental Status Examination (MMSE) score 10-29/30
- on stable dose of medications for 3 months (AChEI, memantine and antidepressants allowed)
- able to speak English
- patient or designate able to sign informed consent
- stable chronic medical conditions (Heart disease, thyroid disease)
- reliable caregiver
Who cannot join
- age <50 years
- medically unstable
- unable to swallow liquids
- diagnosis of diabetes mellitus
- residence in a nursing/long term care home
- allergy to coconut
- allergy to olive oil
About this study
The present study is being done in a scientifically rigorous manner, using readily available MCT oil (refined from coconut oil) versus a placebo oil to assess any cognitive and functional benefits for AD patients.
Read the detailed description
The proposed study, is a randomized placebo controlled cross-over study for 6 months, with an open label extension for another 6 months designed to test the benefits and safety of MCT oil in patients with established AD. It will be the first study on MCT oil ever done with this design, and for this duration in AD.
- Conditions
- Cognitive Function 1, Social
- Being tested
- Bulletproof Brain Octane, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bulletproof Brain OctaneDietary supplement
Medium chain triglyceride oil (MCT)
PlaceboDietary supplement
Placebo (olive) oil
| Study group | Role | What they receive |
|---|---|---|
| medium chain triglyceride (MCT) vs placebo | Placebo comparator | MCT or placebo (olive oil) for 4 months. Crossover at 4 months Receives: Dietary Supplement: Bulletproof Brain Octane; Dietary Supplement: Placebo |
| open label extension | Other | 6 months of MCT oil. Receives: Dietary Supplement: Bulletproof Brain Octane |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognition
Mini Mental Status Examination (MMSE). 0-30. Higher score with higher cognitive function
Measured: 15months
Cognition
Montreal Cognitive Assessment (MoCA) 0-30. Higher score with higher cognition
Measured: 15 months
cognition
Cognigram (Cogstate) 0-200. Higher score with higher cognitive function
Measured: 15 months
Behavior
Neuropsychiatric Inventory (NPI) 0-96 Higher score with more behaviour problems
Measured: 15 months
Function
Katz Activities of Daily Living Scale 0-6 Higher score with poorer ADL function
Measured: 15 months
Secondary outcomes (7)
maximum tolerated daily dose (ml) of MCT oil
tolerability of MCT oil
Measured: 11 months
maximum tolerated daily dose (ml) of placebo (olive) oil
tolerability of placebo oil
Measured: 4 months
Serum cholesterol mmol/l
safety (% change from baseline)
Measured: 15 months
Serum Triglyceride mmol/l
safety (% change from baseline)
Measured: 15 months
Serum Low density lipoprotein (LDL) mmol/l
safety (% change from baseline)
Measured: 15 months
Dual Energy Absorptiometry (DXA) Body fat
safety (% change from baseline)
Measured: 15 months
Incidence of treatment-emergent Adverse events
safety. Mild, moderate or severe events.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study startMar 2016
- Primary completionJan 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Function 1, SocialStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Model description
- randomized, placebo control cross-over study, with an open label extension
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Juby, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396015
- Sponsor's protocol ID
- Pro00054165
- Status last verified
- May 2020
- First submitted
- 5 Oct 2017
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Cognitive and Functional Impairment in Alzheimer's Dementia With a Ketogenic Diet.
- ClinicalTrials.gov ID
- NCT04396015
- Acronym / sponsor ID
- Pro00054165
- Conditions
- Cognitive Function 1, Social
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 20 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study is being done in a scientifically rigorous manner, using readily available MCT oil (refined from coconut oil) versus a placebo oil to assess any cognitive and functional benefits for AD patients.
Detailed description
The proposed study, is a randomized placebo controlled cross-over study for 6 months, with an open label extension for another 6 months designed to test the benefits and safety of MCT oil in patients with established AD. It will be the first study on MCT oil ever done with this design, and for this duration in AD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, placebo control cross-over study, with an open label extension
| Arm | Type | Receives |
|---|---|---|
| medium chain triglyceride (MCT) vs placebo | Placebo comparator | Dietary Supplement: Bulletproof Brain Octane, Dietary Supplement: PlaceboMCT or placebo (olive oil) for 4 months. Crossover at 4 months |
| open label extension | Other | Dietary Supplement: Bulletproof Brain Octane6 months of MCT oil. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients >49years with a clinical diagnosis of AD
- Mini Mental Status Examination (MMSE) score 10-29/30
- on stable dose of medications for 3 months (AChEI, memantine and antidepressants allowed)
- able to speak English
- patient or designate able to sign informed consent
Key exclusion criteria (7 listed)
- age <50 years
- medically unstable
- unable to swallow liquids
- diagnosis of diabetes mellitus
- residence in a nursing/long term care home
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bulletproof Brain OctaneMedium chain triglyceride oil (MCT) | Dietary supplement | medium chain triglyceride (MCT) vs placebo, open label extension |
| PlaceboPlacebo (olive) oil | Dietary supplement | medium chain triglyceride (MCT) vs placebo |
Primary outcome
cognition
Time frame: 15months
Mini Mental Status Examination (MMSE). 0-30. Higher score with higher cognitive function
Cognition
Time frame: 15 months
Montreal Cognitive Assessment (MoCA) 0-30. Higher score with higher cognition
cognition
Time frame: 15 months
Cognigram (Cogstate) 0-200. Higher score with higher cognitive function
Behavior
Time frame: 15 months
Neuropsychiatric Inventory (NPI) 0-96 Higher score with more behaviour problems
Function
Time frame: 15 months
Katz Activities of Daily Living Scale 0-6 Higher score with poorer ADL function
7 secondary outcomes
maximum tolerated daily dose (ml) of MCT oil
Time frame: 11 months
maximum tolerated daily dose (ml) of placebo (olive) oil
Time frame: 4 months
Serum cholesterol mmol/l
Time frame: 15 months
Serum Triglyceride mmol/l
Time frame: 15 months
Serum Low density lipoprotein (LDL) mmol/l
Time frame: 15 months
Dual Energy Absorptiometry (DXA) Body fat
Time frame: 15 months
Incidence of treatment-emergent Adverse events
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Bulletproof Brain Octane in people with Cognitive Function 1, Social, run by University of Alberta.
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 7 inclusion and 7 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 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
cognition (time frame: 15months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2020.