Tolerance and Safety of a Ketone-Promoting Food Ingredient

NCT ID: NCT04707989

Last Updated: 2021-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-11
• Study Completion Date: 2021-03-05

Brief Summary

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

Conditions

Tolerance

Study Design

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

Study Groups

Ketone-Promoting Food Ingredient 1

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

Group Type: EXPERIMENTAL

Ketone- Promoting Food Ingredient #1

Intervention Type: OTHER

Novel proprietary food ingredient (#1) that contains precursors to naturally occurring energy molecules called ketone bodies. Promotes mildly elevated blood ketone concentrations. Mixed into a beverage.

Ketone Free Placebo

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.

Group Type: PLACEBO_COMPARATOR

Ketone Free Placebo

Intervention Type: OTHER

Beverage that is matched to ketone-promoting food ingredient #1 beverage for appearance, taste, texture and volume. Does not contain ketones or ketone precursors.

Ketone-Promoting Food Ingredient 2

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

Group Type: ACTIVE_COMPARATOR

Ketone- Promoting Food Ingredient #2

Intervention Type: OTHER

Previously characterized proprietary food ingredient (#2) that contains precursors to naturally occurring energy molecules called ketone bodies. Promotes mildly elevated blood ketone concentrations. Mixed into a beverage.

Interventions

Ketone- Promoting Food Ingredient #1

Novel proprietary food ingredient (#1) that contains precursors to naturally occurring energy molecules called ketone bodies. Promotes mildly elevated blood ketone concentrations. Mixed into a beverage.

Intervention Type: OTHER

Ketone- Promoting Food Ingredient #2

Previously characterized proprietary food ingredient (#2) that contains precursors to naturally occurring energy molecules called ketone bodies. Promotes mildly elevated blood ketone concentrations. Mixed into a beverage.

Intervention Type: OTHER

Ketone Free Placebo

Beverage that is matched to ketone-promoting food ingredient #1 beverage for appearance, taste, texture and volume. Does not contain ketones or ketone precursors.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BHB Therapeutics, Ireland LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dawn Beckman, MD

Role: PRINCIPAL_INVESTIGATOR

BioFortis

Locations

Biofortis

Addison, Illinois, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23078583 (View on PubMed)

Other Identifiers

BIO-2103

Identifier Type: OTHER

Identifier Source: secondary_id

KEET-2

Identifier Type: -

Identifier Source: org_study_id