Investigating the Efficacy of Brain Octane® Oil on Cognition, Coordination, Reaction Time and Measurements of Physical Performance in Recreationally Active Adults

NCT ID: NCT04095728

Last Updated: 2021-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-30
• Study Completion Date: 2020-05-29

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Investigational Product

Group Type: EXPERIMENTAL

Brain Octane Oil

Intervention Type: 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.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

Brain Octane 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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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.

Intervention Type: OTHER

Other Intervention Names

caprylic acid triglycerides; High Oleic Sunflower Oil

Eligibility Criteria

Inclusion Criteria

1. Provided voluntary, written, informed consent to participate in the study.

2. Males and females between ages 25-55 years old inclusive

3. Body mass index (BMI) in the range of 19.0 and 29.9 kg/m2 inclusive

4. 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:

• 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

5. 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

6. Good general health to perform exercise testing safely, as determined by the Qualified Investigator based on medical history, physical examination, ECG and laboratory results

7. Healthy as determined by laboratory results, medical history, and physical exam by the Qualified Investigator (QI)

8. Willingness to complete questionnaires, records, and diaries associated with the study and to complete all study procedures at all clinic visits

9. Agrees to maintain their normal dietary pattern and exercise routine throughout the study

10. 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

1. Women who are pregnant, breast feeding, or planning to become pregnant during the course of the trial

2. Known allergy to the test material's active or inactive ingredients

3. 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.

4. Visual impairment that limits the ability to perform study assessments

5. 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

6. Blood/bleeding disorders with the exception of a history of anemia caused by a deficiency of a mineral or vitamin, and no longer present

7. Clinically significant abnormal laboratory results at screening as determined by the QI.

8. Any autoimmune disease or immune-compromised (i.e. HIV positive, use of anti-rejection medication, rheumatoid arthritis, etc.)

9. Verbal confirmation of the diagnosis of Hepatitis B/C positive

10. 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

11. 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.

12. 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.

13. 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

14. History of or current diagnosis of Type I or Type II diabetes

15. 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.

16. Alcohol or drug abuse within the last 6 months

17. Use of medical marijuana

18. Use of recreational marijuana unless willing to undergo a 30-day washout prior to baseline

19. 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

20. Consumes a low carbohydrate diet defined as less than 45% of total caloric intake as assessed by 7-day food record

21. Consumes MCT's, beta-hydroxybutyrate, other ketone supplements, coconut oil or palm kernel oil supplements, or goat milk products unless willing to undergo washouts

22. Current or recent use of oil supplements (fish oil, conjugated linoleic acid, etc.) unless willing to undergo specified washouts

23. 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.)

24. 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.

25. Blood donation 30 days prior to screening, during the study, or a planned donation within 30 days of the last study visit

26. Individuals who are cognitively impaired and/or who are unable to give informed consent

27. Participation in other clinical research trials one month prior to randomization will be assessed case-by-case by the QI

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

KGK Science Inc.

INDUSTRY

Sponsor Role: collaborator

Bulletproof 360, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Crowley, MD

Role: PRINCIPAL_INVESTIGATOR

KGK Science Inc.

Locations

KGK Science Inc.

London, Ontario, Canada

Countries

Canada

Other Identifiers

19BCHB

Identifier Type: -

Identifier Source: org_study_id