Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
34 participants
INTERVENTIONAL
2022-04-11
2022-08-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
12.5 g/d of C6 ketone di-ester
Low dose of ketone di-ester.
C6 ketone di-ester
C6 ketone di-ester
25 g/d of C6 ketone di-ester
Middle dose of ketone di-ester.
C6 ketone di-ester
C6 ketone di-ester
50 g/d of C6 ketone di-ester
Highest dose of ketone di-ester.
C6 ketone di-ester
C6 ketone di-ester
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
C6 ketone di-ester
C6 ketone di-ester
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subject is willing to consume the study beverage daily starting on Day 0 through Day 7 following taste testing at Visit 1
* Subject is not a smoker and has no plans to change his/her usage of the following products throughout the study period: tobacco, smoking products (including, but not limited to cigarettes, cigars, chewing tobacco, e-cigarettes), and nicotine products (e.g., nicotine gum and/or nicotine patches)
* Subject is a non-user or former user (cessation ≥3 months) of any marijuana or hemp products and has no plans to use marijuana or hemp products during the study period. No washout is required for topical marijuana or hemp products, but subjects are required to abstain from these products during the study period.
* Subject is willing and able to comply with all study procedures including overnight fasting (12 ± 2 h, water only), maintenance of usual body weight, avoidance of foods or supplements that increase ketone production in the body throughout the entire study period, avoidance of vigorous exercise (moderate habitual exercise is allowed) with the exception of the 24 h prior to Visits 2 and 3 (Days 0 and 7) when subjects must avoid exercise completely
* Subjects is willing to abstain from caffeine during Visits 2 and 3 (Days 0 and 7).
* Subject has a score of 7 to 10 on the Vein Access Scale
* Subject is willing and able to comply with the visit schedule.
* Subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history, physical examination findings, and routine laboratory test results.
* Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator.
Exclusion Criteria
* Subject has extreme dietary habits (e.g., intermittent fasting or time restricted eating, Atkins diet, vegan, very high protein/low carbohydrate)
* Subject has used weight-loss medications (including over-the-counter medications and/or supplements) or participated in weight loss programs
* Unstable use of any prescription medications is not allowed.
* Subject has used ketone supplements (ketone salts or esters, and medium chain triglycerides \[MCT\]) within 30 days
* Subject has been exposed to any non-registered drug product within 30 days of Visit 1
* Subject has a history or presence of clinically important endocrine (including hyperparathyroidism, type 1 or 2 diabetes mellitus and/or hypoglycemia), cardiovascular (including, but not limited to history of myocardial infarction, peripheral arterial disease, stroke), pulmonary (including uncontrolled asthma), hepatic, renal, gastrointestinal, hematologic, immunologic, dermatologic, rheumatic (including gout), and/or biliary condition(s), that, in the opinion of the Clinical Investigator (has MD qualifications), could interfere with the interpretation of the study results.
* Subject has a history of bariatric surgery for weight reducing purposes
* Subject has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer.
* Subject has an abnormal laboratory test result(s) of clinical importance at Visit 1 (Day -7), at the discretion of the Clinical Investigator. One re-test will be allowed on a separate day prior to Visit 2 (Day 0), for subjects with abnormal laboratory test results.
* Subject has any signs or symptoms of an active infection of clinical relevance (e.g., urinary tract or respiratory) within 5 days of Visit 2 (Day 0). If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have resolved (at the discretion of the Clinical Investigator) and any treatment (e.g., antibiotic therapy) has been completed at least 5 days prior to testing.
* Subject has experienced any major trauma or any other surgical event within three months
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mérieux NutriSciences Biofortis
UNKNOWN
BHB Therapeutics, Ireland LTD
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dawn Beckman, MD
Role: PRINCIPAL_INVESTIGATOR
Mérieux NutriSciences Biofortis
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Biofortis
Addison, Illinois, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BIO-2201
Identifier Type: -
Identifier Source: org_study_id