HealthyNCT04095728
Investigating the Efficacy of Brain Octane® Oil on Cognition, Coordination, Reaction Time and Measurements of Physical Performance in Recreationally Active Adults
A study testing Brain Octane Oil in people with Healthy, run by Bulletproof 360, Inc. at 1 site in Canada.
Trial summary
This is a randomized, double-blind, placebo-controlled, parallel study investigating the efficacy of Brain Octane® Oil on cognition, coordination, reaction time and measurements of physical performance in recreationally active adults. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Brain Octane Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 30 Sep 2019to 29 May 2020
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provided voluntary, written, informed consent to participate in the study.
- Males and females between ages 25-55 years old inclusive
- Body mass index (BMI) in the range of 19.0 and 29.9 kg/m2 inclusive
- Female participants not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, total endometrial ablation) or have been post-menopausal (natural or surgically) for at least 1 year prior to screening
- Or,
- Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
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- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Double-barrier method
- Intrauterine devices
- Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner at least 6 months prior to screening
- Athletes engaging in endurance exercise (examples include but are not limited to running, cycling, swimming, and skiing) at least 1x per week for a weekly total of at least 1-hour
- Good general health to perform exercise testing safely, as determined by the Qualified Investigator based on medical history, physical examination, ECG and laboratory results
- Healthy as determined by laboratory results, medical history, and physical exam by the Qualified Investigator (QI)
- Willingness to complete questionnaires, records, and diaries associated with the study and to complete all study procedures at all clinic visits
- Agrees to maintain their normal dietary pattern and exercise routine throughout the study
- Agrees to maintain their daily caloric intake by adjusting their normal diet to account for the additional 250 calories from the Brain Octane® Oil
Who cannot join
- Women who are pregnant, breast feeding, or planning to become pregnant during the course of the trial
- Known allergy to the test material's active or inactive ingredients
- Abnormal respiratory function (examples include but are not limited to asthma, exercise-induced asthma, exercise-induced respiratory problems) that in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant.
- Visual impairment that limits the ability to perform study assessments
- Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
- Blood/bleeding disorders with the exception of a history of anemia caused by a deficiency of a mineral or vitamin, and no longer present
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- Clinically significant abnormal laboratory results at screening as determined by the QI.
- Any autoimmune disease or immune-compromised (i.e. HIV positive, use of anti-rejection medication, rheumatoid arthritis, etc.)
- Verbal confirmation of the diagnosis of Hepatitis B/C positive
- Verbal confirmation of current or pre-existing thyroid condition except for hypothyroidism that has been treated with a stable dose of medication for at least 6 months
- Cardiac diseases that in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant.
- Liver or renal conditions (e.g. cirrhosis of the liver, kidney disease, etc.) that in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant. Asymptomatic kidney stones are allowed.
- Current oral or gastrointestinal pathology (e.g. mouth ulcers, chronic diarrhea, inflammatory bowel disease, uncontrolled GERD), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), or other conditions known to interfere with the absorption, distribution, metabolism or excretion
- History of or current diagnosis of Type I or Type II diabetes
- Presence or history of neurological disorders or significant psychiatric illness that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant.
- Alcohol or drug abuse within the last 6 months
- Use of medical marijuana
- Use of recreational marijuana unless willing to undergo a 30-day washout prior to baseline
- Use of any form of tobacco, including cigarette smoking, pipe smoking, or oral tobacco during the course of the trial; if a former smoker or tobacco user, the subject must not have used tobacco for 3 months before baseline
- Consumes a low carbohydrate diet defined as less than 45% of total caloric intake as assessed by 7-day food record
- Consumes MCT's, beta-hydroxybutyrate, other ketone supplements, coconut oil or palm kernel oil supplements, or goat milk products unless willing to undergo washouts
- Current or recent use of oil supplements (fish oil, conjugated linoleic acid, etc.) unless willing to undergo specified washouts
- Current or recent use of medications including drugs known to affect lipid or glucose metabolism unless willing to undergo washouts (e.g. steroids, beta-blockers, diuretics, insulin sensitizers, etc.)
- Any other active or unstable medical condition, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant.
- Blood donation 30 days prior to screening, during the study, or a planned donation within 30 days of the last study visit
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Participation in other clinical research trials one month prior to randomization will be assessed case-by-case by the QI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Study Investigating the Efficacy of Brain Octane® Oil (Caprylic Acid Triglycerides) on Cognition, Coordination, Reaction Time and Measurements of Physical Performance in Recreationally Active Adults
This is a randomized, double-blind, placebo-controlled, parallel study investigating the efficacy of Brain Octane® Oil on cognition, coordination, reaction time and measurements of physical performance in recreationally active adults. Thirty eligible participants will consume the investigational product or placebo for 27 days. 15 participants will consume the investigational product and 15 participants will receive the placebo product to consume.
The primary outcome is assessing reaction time, cognition, and the ability to perform cognitive tasks. Assessments will be conducted at baseline, and end of study (30 days apart).
- Conditions
- Healthy
- Being tested
- Brain Octane Oil, Placebo
- Keywords
- Cognition, Healthy, Brain Octane Oil, Caprylic acid triglycerides, Physical performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Octane OilDietary supplement
Also called caprylic acid triglycerides
Participants will complete a 7-day dose escalation period, and then consume 2 servings of the study product (1 serving = 1 tablespoon) for 21 days.
PlaceboOther
Also called High Oleic Sunflower Oil
Participants will complete a 7-day dose escalation period, and then consume 2 servings of the study product (1 serving = 1 tablespoon) for 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Product | Experimental | Not described Receives: Dietary Supplement: Brain Octane Oil |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the change from baseline to day 30 between Brain Octane® Oil vs. placebo on reaction time as assessed by Dynavision D2 tests after first and second doses of Brain Octane® Oil
The Dynavision is a large, computerized light board with 64 buttons arranged in five concentric circles around an above-center, LCD display called the T-scope. The device allows for adjustable height and is adjusted for each participant such that the T-scope is approximately at eye level.The D2 version of the device connects to a laptop computer where results are displayed in a graph format, presenting individual progress. Participants will have their visual, motor, and physical reaction time measured using the Reaction Mode and Mode A on the Dynavision D2.
Measured: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil vs. placebo on coordination as assessed by a Dynavision D2 test after first and second doses of Brain Octane® Oil
The Dynavision is a large, computerized light board with 64 buttons arranged in five concentric circles around an above-center, LCD display called the T-scope. The device allows for adjustable height and is adjusted for each participant such that the T-scope is approximately at eye level.The D2 version of the device connects to a laptop computer where results are displayed in a graph format, presenting individual progress. participants will have their coordination measured using the Mode A on the Dynavision D2.
Measured: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil vs. placebo on the ability to perform cognitive tasks as assessed by a Dynavision D2 test and mod. Serial Sevens Test after first and second doses of Brain Octane® Oil
The Dynavision is a large, computerized light board with 64 buttons arranged in five concentric circles around an above-center, LCD display called the T-scope. The device allows for adjustable height and is adjusted for each participant such that the T-scope is approximately at eye level.The D2 version of the device connects to a laptop computer where results are displayed in a graph format, presenting individual progress. Participants will have their cognition measured using the Mode B on the Dynavision D2 device.
The Serial Sevens Test was first introduced in the 1940's by Hayman for neurological examinations with regards to mental function in individuals with brain lesions. Over time, it has been modified and used to analyze cognitive function in healthy individuals.
Measured: 30 days
Secondary outcomes (16)
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in VO2Max (maximal oxygen consumption using cycle ergometer testing) as measured by Cardiocoach
The ergometer used will be an electromagnetically-controlled, stationary bicycle. Participants will use the ergometer in a temperature-controlled room, while intensity is incrementally increased. It will begin at 78W and increase by 39W every 3 minutes until volitional exhaustion by the participant. Participants will be instructed to maintain a cadence of 80 revolutions/min.
Measured: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in gas exchange threshold (GET, a measure of aerobic efficiency) as measured by Cardiocoach
The ergometer used will be an electromagnetically-controlled, stationary bicycle. Participants will use the ergometer in a temperature-controlled room, while intensity is incrementally increased. It will begin at 78W and increase by 39W every 3 minutes until volitional exhaustion by the participant. Participants will be instructed to maintain a cadence of 80 revolutions/min.
Measured: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in recovery from physical stress using Physical Fatigue Questionnaire
The Physical Fatigue Questionnaire uses a four-point scale to categorize physical fatigue. The scale ranges from zero (0) indicating no worse than usual to three (3) indicating much worse than usual. Individual question scores will be summed together to give a total score. A higher total score indicates more fatigue.
Measured: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in recovery from physical stress using Delayed Onset Muscle Soreness (DOMS) Questionnaire
The DOMS Questionnaire uses a seven-point scale to categorize muscle soreness. The scale ranges from one (1) indicating no pain to seven (7) indicating severe pain limiting the ability to move. Individual question scores will be summed together to give a total score. A higher total score indicates more DOMS.
Measured: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in acetoacetate plasma ketone measured before the first and second Dynavision tests
This will be analysed from blood samples.
Measured: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in beta-hydroxybutyrate plasma ketone measured before the first and second Dynavision tests
This will be analysed from blood samples.
Measured: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in glucose measured before first and second Dynavision D2 tests
This will be analysed from blood samples.
Measured: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in insulin measured before first and second Dynavision D2 tests
This will be analysed from blood samples.
Measured: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in creatine kinase measured before and after cycle ergometer testing
This will be analysed from blood samples.
Measured: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in fat body weight
Assess using bioelectrical impedance analysis (BIA)
Measured: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in percent body fat
Assess using bioelectrical impedance analysis (BIA)
Measured: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in lean dry mass
Assess using bioelectrical impedance analysis (BIA)
Measured: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in percent lean dry mass
Assess using bioelectrical impedance analysis (BIA)
Measured: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in total body water
Assess using bioelectrical impedance analysis (BIA)
Measured: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in percent body weight body water
Assess using bioelectrical impedance analysis (BIA)
Measured: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in basal metabolic rate
Assess using bioelectrical impedance analysis (BIA)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start30 Sep 2019
- Primary completion29 Feb 2020
- Study completion29 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bulletproof 360, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095728
- Sponsor's protocol ID
- 19BCHB
- Status last verified
- Jan 2021
- First submitted
- 16 Sep 2019
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel Study Investigating the Efficacy of Brain Octane® Oil (Caprylic Acid Triglycerides) on Cognition, Coordination, Reaction Time and Measurements of Physical Performance in Recreationally Active Adults
- ClinicalTrials.gov ID
- NCT04095728
- Acronym / sponsor ID
- 19BCHB
- Conditions
- Healthy
- Keywords
- Cognition, Healthy, Brain Octane Oil, Caprylic acid triglycerides, Physical performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bulletproof 360, Inc.Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 29 May 2020 (actual)
- First posted
- 19 Sep 2019 (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.
This is a randomized, double-blind, placebo-controlled, parallel study investigating the efficacy of Brain Octane® Oil on cognition, coordination, reaction time and measurements of physical performance in recreationally active adults. Thirty eligible participants will consume the investigational product or placebo for 27 days. 15 participants will consume the investigational product and 15 participants will receive the placebo product to consume.
The primary outcome is assessing reaction time, cognition, and the ability to perform cognitive tasks. Assessments will be conducted at baseline, and end of study (30 days apart).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Product | Experimental | Dietary Supplement: Brain Octane Oil |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Provided voluntary, written, informed consent to participate in the study.
- Males and females between ages 25-55 years old inclusive
- Body mass index (BMI) in the range of 19.0 and 29.9 kg/m2 inclusive
- Female participants not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, total endometrial ablation) or have been post-menopausal (natural or surgically) for at least 1 year prior to screening
- Or,
Key exclusion criteria (27 listed)
- Women who are pregnant, breast feeding, or planning to become pregnant during the course of the trial
- Known allergy to the test material's active or inactive ingredients
- Abnormal respiratory function (examples include but are not limited to asthma, exercise-induced asthma, exercise-induced respiratory problems) that in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant.
- Visual impairment that limits the ability to perform study assessments
- Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
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 |
|---|---|---|
| Brain Octane OilAlso: caprylic acid triglyceridesParticipants will complete a 7-day dose escalation period, and then consume 2 servings of the study product (1 serving = 1 tablespoon) for 21 days. | Dietary supplement | Investigational Product |
| PlaceboAlso: High Oleic Sunflower OilParticipants will complete a 7-day dose escalation period, and then consume 2 servings of the study product (1 serving = 1 tablespoon) for 21 days. | Other | Placebo |
Primary outcome
Comparison of the change from baseline to day 30 between Brain Octane® Oil vs. placebo on reaction time as assessed by Dynavision D2 tests after first and second doses of Brain Octane® Oil
Time frame: 30 days
The Dynavision is a large, computerized light board with 64 buttons arranged in five concentric circles around an above-center, LCD display called the T-scope. The device allows for adjustable height and is adjusted for each participant such that the T-scope is approximately at eye level.The D2 version of the device connects to a laptop computer where results are displayed in a graph format, presenting individual progress. Participants will have their visual, motor, and physical reaction time measured using the Reaction Mode and Mode A on the Dynavision D2.
Comparison of the change from baseline to day 30 between Brain Octane® Oil vs. placebo on coordination as assessed by a Dynavision D2 test after first and second doses of Brain Octane® Oil
Time frame: 30 days
The Dynavision is a large, computerized light board with 64 buttons arranged in five concentric circles around an above-center, LCD display called the T-scope. The device allows for adjustable height and is adjusted for each participant such that the T-scope is approximately at eye level.The D2 version of the device connects to a laptop computer where results are displayed in a graph format, presenting individual progress. participants will have their coordination measured using the Mode A on the Dynavision D2.
Comparison of the change from baseline to day 30 between Brain Octane® Oil vs. placebo on the ability to perform cognitive tasks as assessed by a Dynavision D2 test and mod. Serial Sevens Test after first and second doses of Brain Octane® Oil
Time frame: 30 days
The Dynavision is a large, computerized light board with 64 buttons arranged in five concentric circles around an above-center, LCD display called the T-scope. The device allows for adjustable height and is adjusted for each participant such that the T-scope is approximately at eye level.The D2 version of the device connects to a laptop computer where results are displayed in a graph format, presenting individual progress. Participants will have their cognition measured using the Mode B on the Dynavision D2 device. The Serial Sevens Test was first introduced in the 1940's by Hayman for neurological examinations with regards to mental function in individuals with brain lesions. Over time, it has been modified and used to analyze cognitive function in healthy individuals.
16 secondary outcomes
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in VO2Max (maximal oxygen consumption using cycle ergometer testing) as measured by Cardiocoach
Time frame: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in gas exchange threshold (GET, a measure of aerobic efficiency) as measured by Cardiocoach
Time frame: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in recovery from physical stress using Physical Fatigue Questionnaire
Time frame: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in recovery from physical stress using Delayed Onset Muscle Soreness (DOMS) Questionnaire
Time frame: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in acetoacetate plasma ketone measured before the first and second Dynavision tests
Time frame: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in beta-hydroxybutyrate plasma ketone measured before the first and second Dynavision tests
Time frame: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in glucose measured before first and second Dynavision D2 tests
Time frame: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in insulin measured before first and second Dynavision D2 tests
Time frame: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in creatine kinase measured before and after cycle ergometer testing
Time frame: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in fat body weight
Time frame: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in percent body fat
Time frame: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in lean dry mass
Time frame: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in percent lean dry mass
Time frame: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in total body water
Time frame: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in percent body weight body water
Time frame: 30 days
Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in basal metabolic rate
Time frame: 30 days
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 27 Jan 2021.
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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.
David Crowley, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Octane Oil in people with Healthy, run by Bulletproof 360, Inc. 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 17 inclusion and 27 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 27 Jan 2021. 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?
Comparison of the change from baseline to day 30 between Brain Octane® Oil vs. placebo on reaction time as assessed by Dynavision D2 tests after first and second doses of Brain Octane® Oil (time frame: 30 days). The study lists 3 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 27 Jan 2021.