Tolerance and Safety of a Ketone-Promoting Food Ingredient

NCT04707989 | Completed

• 2 other identifiers: KEET-2BIO-2103
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Long-term tolerance of ketone promoting food ingredient #1

  Difference between experimental arm (ketone promoting food ingredient #1) vs placebo in composite score of tolerance, assessed by twice daily tolerance questionnaires completed at home. Subjects complete a tolerance questionnaire twice daily, to assess the presence of 10 symptoms before and 4-6h after consuming the study beverage. Questionnaire ranks severity (None, mild, moderate, severe) and incidence (usually, somewhat more than usual, much more than usual). Answers are assigned a numerical value, where higher score is a greater severity and incidence of symptoms. The difference is calculated between the pre- and post- beverage questionnaire for a daily score. Daily scores for the duration of the study are added together to give a single composite score for the whole study period.

  Day From baseline to Day 28

Secondary Outcomes (3)

• Acute tolerance of ketone promoting food ingredient #1

  Days 0, 7 and 14

• Subjective Arousal after ketone promoting food ingredient #1

  From baseline to Day 28

• Safety Blood Profile

  From baseline to Day 28

Other Outcomes (3)

• Long-term tolerance of ketone promoting food ingredient #2

  From baseline to Day 28

• Acute tolerance of ketone promoting food ingredient #2

  Days 0, 7 and 14

• Subjective Arousal after ketone promoting food ingredient #2

  From baseline to Day 28

Study Arms (3)

Ketone-Promoting Food Ingredient 1

EXPERIMENTAL

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

Other: Ketone- Promoting Food Ingredient #1

Ketone Free Placebo

PLACEBO COMPARATOR

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.

Other: Ketone Free Placebo

Ketone-Promoting Food Ingredient 2

ACTIVE COMPARATOR

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

Other: Ketone- Promoting Food Ingredient #2

Interventions

Ketone- Promoting Food Ingredient #1 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-Promoting Food Ingredient 1

Ketone- Promoting Food Ingredient #2 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.

Ketone-Promoting Food Ingredient 2

Ketone Free Placebo 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 Free Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is generally healthy male or female, 18-65 years of age.
• Subject has a BMI 18.5-34.9 kg/m2 (inclusive).
• 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).
• 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.
• 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.
• 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.

You may not qualify if:

• Subject has an abnormal laboratory test result(s) of clinical importance at screening, at the discretion of the Clinical Investigator.
• 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.
• Subject has a clinically important gastrointestinal (GI) condition that would potentially interfere with the evaluation of the study beverage.
• 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.
• 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.
• Subject has a history of or strong potential for alcohol or substance abuse.
• Subject is consistently using prescriptive or over-the counter medications where alcohol is a contraindication at the discretion of the Investigator.
• Subject has a known allergy, intolerance, or sensitivity to any of the ingredients in the study beverages.
• Subject has uncontrolled hypertension as defined by the blood pressure measured at screening.
• Subject has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer.
• Subject has experienced any major trauma or any other surgical event within three months of screening.
• Subject has recently used antibiotics.
• Subject has extreme dietary habits or has used weight-loss medications or programs within 30 days of screening.
• Subject has used medications known to influence gastrointestinal function within 30 days of screening.
• Subject consistently uses anti-inflammatory medications (\>5 times/week) within 30 days of screening.

Sponsors & Collaborators

• BHB Therapeutics, Ireland LTD: lead

Study Sites (1)

Biofortis

Addison, Illinois, 60101, United States

Location

Related Publications (1)

• 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.

  PMID: 23078583 BACKGROUND

Study Officials

• Dawn Beckman, MD

  BioFortis

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: January 13, 2021
• Study Start: December 11, 2020
• Primary Completion: March 5, 2021
• Study Completion: March 5, 2021
• Last Updated: May 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)