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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Product | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain Octane Oil | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in the incidence of adverse events | 30 days | |
| Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in systolic blood pressure | 30 days |
Inclusion Criteria:
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:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Crowley, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Science Inc. | London | Ontario | N6A 5R8 | Canada |
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| Placebo | Other | 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. |
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| 30 days |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 30 days |
| Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in diastolic blood pressure | 30 days |
| Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in heart rate | 30 days |
| Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in complete blood count (CBC) in blood | 30 days |
| Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in sodium levels in blood | 30 days |
| Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in potassium levels in blood | 30 days |
| Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in chloride levels in blood | 30 days |
| Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in fasting glucose levels in blood | 30 days |
| Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in creatinine levels in blood | 30 days |
| Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in Aspartate Aminotransferase (AST) levels in blood | 30 days |
| Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in Alanine Aminotransferase (ALT) levels in blood | 30 days |
| Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in total bilirubin levels in blood | 30 days |
| Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in total cholesterol levels in blood | 30 days |
| Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in total low-density lipoprotein (LDL) levels in blood | 30 days |
| Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in total high-density lipoprotein (HLDL) levels in blood | 30 days |
| Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in triglyceride levels in blood | 30 days |
| Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in NMR Lipoprotein levels in blood | 30 days |
| Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in Lp(a) levels in blood | 30 days |