Clinical trial NCT04707989: Tolerance and Safety of a Ketone-Promoting Food Ingredient
Official title: A Randomized, Placebo Controlled, Study to Evaluate the Tolerance and Safety of a Ketone- Promoting Food Ingredient in Healthy Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tolerance
Lead sponsor: BHB Therapeutics, Ireland LTD
Sponsor class: INDUSTRY
First posted: 2021-01-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of this study is to capture information on tolerance and safety of a ketone-promoting food ingredient in healthy adults.


Eligibility criteria: Inclusion Criteria:

1. Subject is generally healthy male or female, 18-65 years of age.
2. Subject has a BMI 18.5-34.9 kg/m2 (inclusive).
3. Subject is willing and able to comply with all study procedures including consumption of breakfast and lunch daily, maintenance of habitual dietary intake, exercise and medication and supplement use, blood draws and the following prior to test visits: fasting (\>10 h; water only), no alcohol (\>10 h), no cannabis products (\>10 h) and no exercise (\>10 h).
4. Subject has internet access via computer, phone, or other device and is able to maintain internet access throughout the trial in order to complete online daily questionnaires.
5. Subject has no health conditions that would prevent him from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history and routine laboratory test results.
6. 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:

1. Subject has an abnormal laboratory test result(s) of clinical importance at screening, at the discretion of the Clinical Investigator.
2. Subject has a history or presence of uncontrolled and/or clinically important pulmonary, cardiac, hepatic, renal, endocrine (including type 1 and 2 diabetes), hematologic, immunologic, neurologic, psychiatric or biliary disorders at the discretion of the Investigator.
3. Subject has a clinically important gastrointestinal (GI) condition that would potentially interfere with the evaluation of the study beverage.
4. Subject is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
5. Subject is a current user of 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) within 6 months of screening at the equivalent of \>5 cigarettes per day.
6. Subject has a history of or strong potential for alcohol or substance abuse.
7. Subject is consistently using prescriptive or over-the counter medications where alcohol is a contraindication at the discretion of the Investigator.
8. Subject has a known allergy, intolerance, or sensitivity to any of the ingredients in the study beverages.
9. Subject has uncontrolled hypertension as defined by the blood pressure measured at screening.
10. Subject has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer.
11. Subject has experienced any major trauma or any other surgical event within three months of screening.
12. Subject has recently used antibiotics.
13. Subject has extreme dietary habits or has used weight-loss medications or programs within 30 days of screening.
14. Subject has used medications known to influence gastrointestinal function within 30 days of screening.
15. Subject consistently uses anti-inflammatory medications (\>5 times/week) within 30 days of screening.
16. Subject has used ketone supplements within 30 days of screening.
17. Subject has unstable use of thyroid, antihypertensive, antidepressant, or statin medications within 6 months of screening.
18. Individual has a condition the Clinical Investigator believes would interfere with his ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.
19. Subject works nights or shifts that means it is not possible to maintain a consistent meal schedule during the study.

Primary outcomes:
measure: Long-term tolerance of ketone promoting food ingredient #1
timeFrame: Day From baseline to Day 28
Secondary outcomes:
measure: Acute tolerance of ketone promoting food ingredient #1
timeFrame: Days 0, 7 and 14
measure: Subjective Arousal after ketone promoting food ingredient #1
timeFrame: From baseline to Day 28
measure: Safety Blood Profile
timeFrame: From baseline to Day 28
Other outcomes:
measure: Long-term tolerance of ketone promoting food ingredient #2
timeFrame: From baseline to Day 28
measure: Acute tolerance of ketone promoting food ingredient #2
timeFrame: Days 0, 7 and 14
measure: Subjective Arousal after ketone promoting food ingredient #2
timeFrame: From baseline to Day 28
Locations:
city: Addison
country: United States
facility: Biofortis
state: Illinois
Study officials:
affiliation: BioFortis
name: Dawn Beckman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rueger SY, King AC. Validation of the brief Biphasic Alcohol Effects Scale (B-BAES). Alcohol Clin Exp Res. 2013 Mar;37(3):470-6. doi: 10.1111/j.1530-0277.2012.01941.x. Epub 2012 Oct 18.