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

NCT04095728 | Completed

• 1 other identifier: 19BCHB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Cognition; Healthy; Brain Octane Oil; Caprylic acid triglycerides; Physical performance

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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

  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

  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

  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

  30 days

Other Outcomes (19)

• 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

• Comparison of the change from baseline to day 30 between Brain Octane® Oil versus placebo in diastolic blood pressure

  30 days

Study Arms (2)

Investigational Product

EXPERIMENTAL

Dietary Supplement: Brain Octane Oil

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

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.

Also known as: caprylic acid triglycerides

Investigational Product

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.

Also known as: High Oleic Sunflower Oil

Placebo

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Bulletproof 360, Inc.: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6A 5R8, Canada

Location

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 19, 2019
• Study Start: September 30, 2019
• Primary Completion: February 29, 2020
• Study Completion: May 29, 2020
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

CA (1)