ToleranceNCT04707989

Tolerance and Safety of a Ketone-Promoting Food Ingredient

A study testing Ketone- Promoting Food Ingredient #1 and Ketone- Promoting Food Ingredient #2 in people with Tolerance, run by BHB Therapeutics, Ireland LTD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Tolerance
What is being tested?: Ketone- Promoting Food Ingredient #1 and Ketone- Promoting Food Ingredient #2
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 90 participants
Where: 1 siteUnited States
Study dates: 11 Dec 2020to 5 Mar 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 19Show fewer

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.
Subject has used ketone supplements within 30 days of screening.
Subject has unstable use of thyroid, antihypertensive, antidepressant, or statin medications within 6 months of screening.
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.
Subject works nights or shifts that means it is not possible to maintain a consistent meal schedule during the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Biofortis
Addison, Illinois, 60101

Other trials in United States

About this study

Official title: A Randomized, Placebo Controlled, Study to Evaluate the Tolerance and Safety of a Ketone- Promoting Food Ingredient in Healthy Men and Women

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

Conditions: Tolerance
Being tested: Ketone- Promoting Food Ingredient #1, Ketone- Promoting Food Ingredient #2, Ketone Free Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ketone- Promoting Food Ingredient #1Other
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 #2Other
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 Free PlaceboOther
Beverage that is matched to ketone-promoting food ingredient #1 beverage for appearance, taste, texture and volume. Does not contain ketones or ketone precursors.

Study groups in NCT04707989
Study group	Role	What they receive
Ketone-Promoting Food Ingredient 1	Experimental	Novel ketone-promoting food ingredient (#1) administered in a beverage once daily for 28 days. Receives: 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. Receives: 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. Receives: Other: Ketone- Promoting Food Ingredient #2

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day From baseline to Day 28

Secondary outcomes (3)

Acute tolerance of ketone promoting food ingredient #1
Difference between experimental arm (ketone promoting food ingredient #1) vs placebo in composite scores of tolerability, assessed by a tolerance questionnaire at 1h after beverage consumption at clinic visits.
Subjects complete a tolerance questionnaire twice, to assess the presence of 10 symptoms before and 1h 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 score representing acute tolerance.
Measured: Days 0, 7 and 14
Subjective Arousal after ketone promoting food ingredient #1
Difference between experimental arm (ketone promoting food ingredient #1) vs placebo in the composite scores of the stimulatory and sedative subscale using the Brief Biphasic Alcohol Effect Scale (B-BAES); completed twice daily at home.
B-BAES presents 6 items in alphabetical order, and subjects rank them on an 11 point scale, from 0 = not at all to 10 = extremely.
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.
Rueger, S. Y. and A. C. King (2013). "Validation of the brief Biphasic Alcohol Effects Scale (B-BAES)." Alcohol Clin Exp Res 37(3): 470-476.
Measured: From baseline to Day 28
Safety Blood Profile
Change from baseline Day 28 in the incidence of abnormal laboratory test results
Measured: From baseline to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Dec 20205 Mar 2021

First posted13 Jan 2021
Study start11 Dec 2020
Primary completion5 Mar 2021
Study completion5 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ToleranceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04707989
Sponsor's protocol ID: KEET-2
Other IDs: BIO-2103
Status last verified: May 2021
First submitted: 29 Dec 2020
Last updated: 10 May 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 23078583

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Placebo Controlled, Study to Evaluate the Tolerance and Safety of a Ketone- Promoting Food Ingredient in Healthy Men and Women
ClinicalTrials.gov ID: NCT04707989
Acronym / sponsor ID: KEET-2
Conditions: Tolerance
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: BHB Therapeutics, Ireland LTDIndustry (pharma, biotech, devices)
Study start: 11 Dec 2020 (actual)
Primary completion: 5 Mar 2021 (actual)
Study completion: 5 Mar 2021 (actual)
First posted: 13 Jan 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Ketone-Promoting Food Ingredient 1	Experimental	Other: Ketone- Promoting Food Ingredient #1Novel ketone-promoting food ingredient (#1) administered in a beverage once daily for 28 days.
Ketone Free Placebo	Placebo comparator	Other: Ketone Free PlaceboBeverage 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.
Ketone-Promoting Food Ingredient 2	Active comparator	Other: Ketone- Promoting Food Ingredient #2Previously characterized ketone-promoting food ingredient (#2) administered in a beverage once daily for 28 days.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (19 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ketone- Promoting Food Ingredient #1Novel 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.	Other	Ketone-Promoting Food Ingredient 1
Ketone- Promoting Food Ingredient #2Previously 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.	Other	Ketone-Promoting Food Ingredient 2
Ketone Free PlaceboBeverage that is matched to ketone-promoting food ingredient #1 beverage for appearance, taste, texture and volume. Does not contain ketones or ketone precursors.	Other	Ketone Free Placebo

Primary outcome

Long-term tolerance of ketone promoting food ingredient #1
Time frame: Day From baseline to Day 28
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.

3 secondary outcomes

Acute tolerance of ketone promoting food ingredient #1
Time frame: Days 0, 7 and 14
Subjective Arousal after ketone promoting food ingredient #1
Time frame: From baseline to Day 28
Safety Blood Profile
Time frame: From baseline to Day 28

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
Background: PubMed 23078583Rueger 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dawn Beckman, MD principal investigator

BioFortis

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ketone- Promoting Food Ingredient #1 and Ketone- Promoting Food Ingredient #2 in people with Tolerance, run by BHB Therapeutics, Ireland LTD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Long-term tolerance of ketone promoting food ingredient #1 (time frame: Day From baseline to Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04707989, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.