Exogenous KetosisNCT05390385
Acceptability and Tolerability of Ketone Supplements and Effects of BHB Concentrations in Young Adults
A study testing KE1 5g, KE1 10g and KE4 5g in people with Exogenous Ketosis, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Assess the acceptability and tolerability of two different commercially available ketone supplements and determine their effects on capillary blood concentrations of the ketone beta-hydroxybutyrate and glucose in young adults. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Exogenous Ketosis
- What is being tested?
- KE1 5g, KE1 10g and KE4 5g
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2022to 15 Aug 2023
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult 18-25 years of age
- In generally good health
- Able and willing to attend study visits (once every 3 days for ~2 weeks)
- BMI 18.5-29.9
Who cannot join
- Pregnant
- Has preexisting medical conditions, including Type 2 diabetes, heart disease, or cancer
- BMI ≥ 30
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Acceptability and Tolerability of Ketone Supplements and Their Effects on Capillary Beta-hydroxybutyrate Concentrations in Young Adults
Assess the acceptability and tolerability of two different commercially available ketone supplements and determine their effects on capillary blood concentrations of the ketone beta-hydroxybutyrate and glucose in young adults.
Read the detailed description
Past findings suggest that raising ketone concentrations through the use of a ketogenic diet (high-fat, moderate-protein, low-carbohydrate) is effective for preventing weight gain and decreasing appetite. However, strict adherence to this diet is difficult, and ending the diet can result in the regaining of body weight. Our group has investigated the effects of various ketone supplements in both rodents and humans. Past results of our group and that of our colleagues suggest that ketone supplements have the ability to increase ketone concentrations in the blood, decrease appetite, lower body weight, and maintain lean body mass. Exogenous ketones may serve as an alternative to the ketogenic diet by increasing concentrations of ketones without the need for adherence to a strict diet. However, little is known about ketone supplements as it relates to their tolerability and efficacy. For example, the taste of these supplements is unacceptable to some individuals and it is unclear if ketone supplements provide an adequate approach to raise and maintain circulating ketone concentrations as observed with the ketogenic diet. This information will be valuable before launching larger-scale human trials.
Ketone supplements (KE1 and KE4) will be obtained from KetoneAid (Falls Church, VA). Participants will be asked to drink (5g and 10g) of each supplement separated by at least 3 days. Capillary blood samples will be measured using a handheld device to measure circulating beta-hydroxybutyrate (BHB) and glucose concentrations while a questionnaire will be used to assess the acceptability and tolerability of the ketone supplements.
- Conditions
- Exogenous Ketosis
- Being tested
- KE1 5g, KE1 10g, KE4 5g, KE 10g, Placebo drink
- Keywords
- exogenous ketones, ketone supplementation, ketone monoester, ketone salt, tolerability, acceptability, beta-hydroxybutyrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KE1 5gDietary supplement
5g of KE1 (KetoneAid, Falls Church, VA), diluted to 4 ounces
KE1 10gDietary supplement
10g of KE1 (KetoneAid, Falls Church, VA), equal to 4 ounces
KE4 5gDietary supplement
5g of KE4 (KetoneAid, Falls Church, VA), diluted to 4 ounces
KE 10gDietary supplement
10g of KE4 (KetoneAid, Falls Church, VA), diluted to 4 ounces
Placebo drinkOther
Flavor-matched control placebo drink (KetoneAid, Falls Church, VA), 4 ounces
| Study group | Role | What they receive |
|---|---|---|
| Control placebo | Placebo comparator | Not described Receives: Other: Placebo drink |
| KE1 5g | Experimental | Not described Receives: Dietary Supplement: KE1 5g |
| KE1 10g | Experimental | Not described Receives: Dietary Supplement: KE1 10g |
| KE4 5g | Experimental | Not described Receives: Dietary Supplement: KE4 5g |
| KE4 10g | Experimental | Not described Receives: Dietary Supplement: KE 10g |
What is being measured
The primary outcome is the main question the study is designed to answer.
Supplement tolerability and acceptability
The ketone supplements being used have been described as having strong, disagreeable flavors. Therefore, the first outcome measure will be understanding how the flavors and gastrointestinal effects of both supplements may impact subjects. This outcome measure will be assessed by measuring the symptoms experienced, the time at which each symptom occurred, and the duration of each symptom using a scaled symptom questionnaire titled "Symptom Questionnaire." The questionnaire rates symptoms on an ordinal scale from absent, mild, moderate, to severe, with absent being the minimum value and better outcome, and severe being the maximum value and worst outcome. The questionnaire will assess the time that each symptom occurred, on a scale from immediately, one hour, and two hours after supplement consumption. The questionnaire will assess the duration of each symptom, on a scale of less than thirty minutes, one hour, and two hours after each symptom occurred.
Measured: 2 hours
Capillary beta-hydroxybutyrate concentrations
Exogenous ketone supplements are now widely available at the commercial level, so it is important to understand the concentration-dependent effects of these supplements on circulating ketone concentrations, measured by concentrations of beta-hydroxybutyrate following a capillary blood fingerstick.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start23 Sep 2022
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
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 Exogenous KetosisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will each undergo all five treatments, in randomized order. The five treatments include the control placebo, 5g of KE1, 10g of KE1, 5g of KE4, and 10g of KE4. There will be a minimum of two days washout period between treatments.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric P. Plaisance, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390385
- Sponsor's protocol ID
- IRB-300009075
- Status last verified
- Aug 2023
- First submitted
- 13 May 2022
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Stubbs BJ, Cox PJ, Evans RD, Santer P, Miller JJ, Faull OK, Magor-Elliott S, Hiyama S, Stirling M, Clarke K. On the Metabolism of Exogenous Ketones in Humans. Front Physiol. 2017 Oct 30;8:848. doi: 10.3389/fphys.2017.00848. eCollection 2017.
PubMed 29163194
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Tolerability of Ketone Supplements and Their Effects on Capillary Beta-hydroxybutyrate Concentrations in Young Adults
- ClinicalTrials.gov ID
- NCT05390385
- Acronym / sponsor ID
- IRB-300009075
- Conditions
- Exogenous Ketosis
- Keywords
- exogenous ketones, ketone supplementation, ketone monoester, ketone salt, tolerability, acceptability, beta-hydroxybutyrate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 25 May 2022 (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.
Assess the acceptability and tolerability of two different commercially available ketone supplements and determine their effects on capillary blood concentrations of the ketone beta-hydroxybutyrate and glucose in young adults.
Detailed description
Past findings suggest that raising ketone concentrations through the use of a ketogenic diet (high-fat, moderate-protein, low-carbohydrate) is effective for preventing weight gain and decreasing appetite. However, strict adherence to this diet is difficult, and ending the diet can result in the regaining of body weight. Our group has investigated the effects of various ketone supplements in both rodents and humans. Past results of our group and that of our colleagues suggest that ketone supplements have the ability to increase ketone concentrations in the blood, decrease appetite, lower body weight, and maintain lean body mass. Exogenous ketones may serve as an alternative to the ketogenic diet by increasing concentrations of ketones without the need for adherence to a strict diet. However, little is known about ketone supplements as it relates to their tolerability and efficacy. For example, the taste of these supplements is unacceptable to some individuals and it is unclear if ketone supplements provide an adequate approach to raise and maintain circulating ketone concentrations as observed with the ketogenic diet. This information will be valuable before launching larger-scale human trials.
Ketone supplements (KE1 and KE4) will be obtained from KetoneAid (Falls Church, VA). Participants will be asked to drink (5g and 10g) of each supplement separated by at least 3 days. Capillary blood samples will be measured using a handheld device to measure circulating beta-hydroxybutyrate (BHB) and glucose concentrations while a questionnaire will be used to assess the acceptability and tolerability of the ketone supplements.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- Participants will each undergo all five treatments, in randomized order. The five treatments include the control placebo, 5g of KE1, 10g of KE1, 5g of KE4, and 10g of KE4. There will be a minimum of two days washout period between treatments.
| Arm | Type | Receives |
|---|---|---|
| Control placebo | Placebo comparator | Other: Placebo drink |
| KE1 5g | Experimental | Dietary Supplement: KE1 5g |
| KE1 10g | Experimental | Dietary Supplement: KE1 10g |
| KE4 5g | Experimental | Dietary Supplement: KE4 5g |
| KE4 10g | Experimental | Dietary Supplement: KE 10g |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult 18-25 years of age
- In generally good health
- Able and willing to attend study visits (once every 3 days for ~2 weeks)
- BMI 18.5-29.9
Key exclusion criteria (3 listed)
- Pregnant
- Has preexisting medical conditions, including Type 2 diabetes, heart disease, or cancer
- BMI ≥ 30
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 |
|---|---|---|
| KE1 5g5g of KE1 (KetoneAid, Falls Church, VA), diluted to 4 ounces | Dietary supplement | KE1 5g |
| KE1 10g10g of KE1 (KetoneAid, Falls Church, VA), equal to 4 ounces | Dietary supplement | KE1 10g |
| KE4 5g5g of KE4 (KetoneAid, Falls Church, VA), diluted to 4 ounces | Dietary supplement | KE4 5g |
| KE 10g10g of KE4 (KetoneAid, Falls Church, VA), diluted to 4 ounces | Dietary supplement | KE4 10g |
| Placebo drinkFlavor-matched control placebo drink (KetoneAid, Falls Church, VA), 4 ounces | Other | Control placebo |
Primary outcome
Supplement tolerability and acceptability
Time frame: 2 hours
The ketone supplements being used have been described as having strong, disagreeable flavors. Therefore, the first outcome measure will be understanding how the flavors and gastrointestinal effects of both supplements may impact subjects. This outcome measure will be assessed by measuring the symptoms experienced, the time at which each symptom occurred, and the duration of each symptom using a scaled symptom questionnaire titled "Symptom Questionnaire." The questionnaire rates symptoms on an ordinal scale from absent, mild, moderate, to severe, with absent being the minimum value and better outcome, and severe being the maximum value and worst outcome. The questionnaire will assess the time that each symptom occurred, on a scale from immediately, one hour, and two hours after supplement consumption. The questionnaire will assess the duration of each symptom, on a scale of less than thirty minutes, one hour, and two hours after each symptom occurred.
Capillary beta-hydroxybutyrate concentrations
Time frame: 2 hours
Exogenous ketone supplements are now widely available at the commercial level, so it is important to understand the concentration-dependent effects of these supplements on circulating ketone concentrations, measured by concentrations of beta-hydroxybutyrate following a capillary blood fingerstick.
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 16 Aug 2023.
- Background: PubMed 29163194Stubbs BJ, Cox PJ, Evans RD, Santer P, Miller JJ, Faull OK, Magor-Elliott S, Hiyama S, Stirling M, Clarke K. On the Metabolism of Exogenous Ketones in Humans. Front Physiol. 2017 Oct 30;8:848. doi: 10.3389/fphys.2017.00848. eCollection 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Exogenous Ketosis
Not yet recruitingEarly Phase 1
The Effects of Ketone Supplements With Carbohydrates on Cycling Performance Above Lactate Threshold
Exogenous Ketosis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KE1 5g, KE1 10g and KE4 5g in people with Exogenous Ketosis, run by University of Alabama at Birmingham 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 4 inclusion and 3 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 16 Aug 2023. 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?
Supplement tolerability and acceptability (time frame: 2 hours). The study lists 2 primary outcomes in all. 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 NCT05390385, 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 16 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.