Tolerance and Safety of a Ketone-Promoting Food Ingredient

BHB Therapeutics

Status: Completed

Conditions: Tolerance

Treatments: Other: Ketone Free Placebo; Other: Ketone- Promoting Food Ingredient #2; Other: Ketone- Promoting Food Ingredient #1

Study type: Interventional

Funder types: Industry

Identifiers

NCT04707989

KEET-2

BIO-2103 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 90 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

Ketone-Promoting Food Ingredient 1

Experimental group

Description:

Novel ketone-promoting food ingredient (#1) administered in a beverage once daily for 28 days.

Treatment:

Other: Ketone- Promoting Food Ingredient #1

Ketone Free Placebo

Placebo Comparator group

Description:

Beverage matched for appearance, volume, taste and texture to experimental arm (ketone promoting food ingredient #1) that does NOT contain a ketone ingredient. Consumed once daily for 28 days.

Treatment:

Other: Ketone Free Placebo

Ketone-Promoting Food Ingredient 2

Active Comparator group

Description:

Previously characterized ketone-promoting food ingredient (#2) administered in a beverage once daily for 28 days.

Treatment:

Other: Ketone- Promoting Food Ingredient #2