Healthy VolunteerNCT07289165
Comparison of Pharmacokinetic Responses to Three Ketone Esters
A study testing Dietary Supplement containing Tri-betahydroxybutyrin, Dietary Supplement containing a ketone mono Ester and Dietary supplement containing a ketone salt in people with Healthy Volunteer, run by NeuroEnergy Ventures, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to examine how the body absorbs, digests, and metabolizes three different investigational ketone dietary supplements (ketone monoester, ketone tri-ester, ketone salt) and to assess gastrointestinal tolerance or other adverse effects. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Dietary Supplement containing Tri-betahydroxybutyrin, Dietary Supplement containing a ketone mono Ester and Dietary supplement containing a ketone salt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2025to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Provide voluntary signed and dated informed consent.
- Be in good health as determined by medical history and routine blood chemistries.
- Age between 30 and 70 yr (inclusive).
- Body Mass Index of 25-34.9 (inclusive).
- Body weight of at least 120 pounds.
- Normotensive (seated, resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5 minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
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- Normal seated, resting heart rate (<90 per minute).
- Willing to duplicate and record their previous 24-hour diet, refrain from caffeine, alcohol and exercise for 24 hours prior to each visit, and fast for 10 hours prior to each visit.
- Subject agrees to maintain existing dietary and physical activity patterns throughout the study period.
- Subject is willing and able to comply with the study protocol.
Who cannot join
- Individuals using any kind of GLP-1 medications.
- Individuals who are determined to have liver, renal, cardiovascular, neurological, or other metabolic disease.
- History or presence of diabetes, prediabetes or endocrine disorder.
- Use of any dietary supplements or medications which may confound the study or its endpoints (e.g., fish oil, choline donors, gingko biloba, phosphatidylserine, huperzine A, etc.).
- Alcohol consumption (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or drug abuse or dependence within the past 6 months.
- Current nicotine use > 100 mg/day.
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- History of hyperparathyroidism or an untreated thyroid condition.
- History of malignancy in the previous 5 years, except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
- History of chronic psychiatric conditions (e.g., bipolar, schizophrenia, PTSD, depression, etc.).
- History of brain disorders [e.g., stroke, MS, Parkinson's, history of TBI or epilepsy, migraine (>1 migraine per month), etc.].
- Prior gastrointestinal bypass surgery (Lapband), etc.
- Other known gastrointestinal or metabolic conditions that might impact nutrient absorption or metabolism, e.g., short bowel syndrome, Inflammatory bowel syndrome (IBS), Inflammatory bowel disease (IBD; e.g., Crohn's, ulcerative colitis), diarrheal illnesses, history of colon resection, gastro paresis, Inborn-Errors-of-Metabolism (such as PKU).
- Chronic inflammatory condition (e.g., rheumatoid arthritis, Lupus, HIV/AIDS, etc.).
- Previous medical diagnosis of asthma, gout, or fibromyalgia.
- Currently following a low-carbohydrate, keto type diet, or practicing an intermittent fasting lifestyle (>14 hours of fasting).
- Subjects that have donated blood or plasma within the previous week.
- Pregnant women, women trying to become pregnant, women less than 120 days postpartum or nursing women. Women who participate in this study must agree to the use of contraception for the duration of the study and any woman that is sexually active will have to take pregnancy test prior to enrolling with a negative result. Women of childbearing age (any woman prior to menopause) regardless of their use of contraception will be provided a urine pregnancy test kit at their screening visit and take the test in private using the female lavatory after signing an informed consent.
- Known sensitivity to any ingredient in the test formulations as listed in the product label.
- Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.
- Clinically significant abnormal laboratory results at screening.
- Any other conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine how the body absorbs, digests, and metabolizes three different investigational ketone dietary supplements (ketone monoester, ketone tri-ester, ketone salt) and to assess gastrointestinal tolerance or other adverse effects. This study is considered investigational because data are being collected on the differences over time between three active study products. Consumption of these study products are not intended to diagnose, treat, cure, or prevent any disease.
Read the detailed description
- This study is a randomized, double-blind, crossover trial of N=18 apparently healthy men and women between 30 and 70 years old to be recruited at a single investigational center.
- Participants will attend 7 study visits. During Visit 1 participants will be screened for eligibility [i.e., medical history, routine blood work, background baseline diet]. During visits 2, 4, and 6 participants will undergo consumption of a study product (either ketone monester, ketone triester, or ketone salt) and serial blood draws for serum beta-hydroxybutyrate (BHB) will be used to assess the pharmacokinetic (PK) response over an 8-hour period with an additional 24-hour post-ingestion blood draw (to occur on visits 3, 5 and 7). In addition, participants will rate their overall GI tolerance, alertness, and focus via visual analog scales (VAS). During visits 3, 5 and 7 (which will be 24 hours after visits 2, 4, and 6, respectively) participants will undergo a single blood draw for BHB at the 24-hour post ingestion time point and rate their overall GI tolerance via VAS.
- Comprehensive side effect profile/ adverse event monitoring will take place throughout the study duration. The study will be conducted following ICH-GCP guidelines to ensure subject safety and scientific integrity of the data.
- Conditions
- Healthy Volunteer
- Being tested
- Dietary Supplement containing Tri-betahydroxybutyrin, Dietary Supplement containing a ketone mono Ester, Dietary supplement containing a ketone salt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Supplement containing Tri-betahydroxybutyrinDietary supplement
Ketone Tri Ester
Dietary Supplement containing a ketone mono EsterDietary supplement
Ketone Mono Ester
Dietary supplement containing a ketone saltDietary supplement
Dietary Supplement from a ketone salt
| Study group | Role | What they receive |
|---|---|---|
| 12.5mg Ketone Tri Ester | Active comparator | Dietary Supplement containing Tri-betahydroxybutyrin Receives: Dietary Supplement: Dietary Supplement containing Tri-betahydroxybutyrin |
| 12.5mg Ketone Mono Ester | Active comparator | Dietary Supplement containing a ketone mono Ester Receives: Dietary Supplement: Dietary Supplement containing a ketone mono Ester |
| 12.5mg Ketone Salt | Active comparator | Dietary supplement containing a ketone salt Receives: Dietary Supplement: Dietary supplement containing a ketone salt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum BHB concentration maximum (Cmax)
Measured: blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product
time to maximum concentration (Tmax)
Measured: blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product
area under the curve (AUC),
Measured: blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product
elimination half-life (T1/2),
Measured: blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product
oral clearance
Measured: blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product
volume of distribution
Measured: blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product
Secondary outcomes (2)
Visual Analogue Scale for GI tolerance
Measured: assessed at 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product
Safety (vital signs) and Adverse Events
Measured: assessed at 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start15 Jul 2025
- Primary completionDec 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroEnergy Ventures, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tim Ziegenfuss, PhD, Principal investigator, CAHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289165
- Sponsor's protocol ID
- NE-01-2025
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pharmacokinetic Responses to Three Ketone Esters
- ClinicalTrials.gov ID
- NCT07289165
- Acronym / sponsor ID
- NE-01-2025
- Conditions
- Healthy Volunteer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (actual)
- Lead sponsor
- NeuroEnergy Ventures, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 17 Dec 2025 (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 purpose of this study is to examine how the body absorbs, digests, and metabolizes three different investigational ketone dietary supplements (ketone monoester, ketone tri-ester, ketone salt) and to assess gastrointestinal tolerance or other adverse effects. This study is considered investigational because data are being collected on the differences over time between three active study products. Consumption of these study products are not intended to diagnose, treat, cure, or prevent any disease.
Detailed description
- This study is a randomized, double-blind, crossover trial of N=18 apparently healthy men and women between 30 and 70 years old to be recruited at a single investigational center.
- Participants will attend 7 study visits. During Visit 1 participants will be screened for eligibility [i.e., medical history, routine blood work, background baseline diet]. During visits 2, 4, and 6 participants will undergo consumption of a study product (either ketone monester, ketone triester, or ketone salt) and serial blood draws for serum beta-hydroxybutyrate (BHB) will be used to assess the pharmacokinetic (PK) response over an 8-hour period with an additional 24-hour post-ingestion blood draw (to occur on visits 3, 5 and 7). In addition, participants will rate their overall GI tolerance, alertness, and focus via visual analog scales (VAS). During visits 3, 5 and 7 (which will be 24 hours after visits 2, 4, and 6, respectively) participants will undergo a single blood draw for BHB at the 24-hour post ingestion time point and rate their overall GI tolerance via VAS.
- Comprehensive side effect profile/ adverse event monitoring will take place throughout the study duration. The study will be conducted following ICH-GCP guidelines to ensure subject safety and scientific integrity of the data.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 12.5mg Ketone Tri Ester | Active comparator | Dietary Supplement: Dietary Supplement containing Tri-betahydroxybutyrinDietary Supplement containing Tri-betahydroxybutyrin |
| 12.5mg Ketone Mono Ester | Active comparator | Dietary Supplement: Dietary Supplement containing a ketone mono EsterDietary Supplement containing a ketone mono Ester |
| 12.5mg Ketone Salt | Active comparator | Dietary Supplement: Dietary supplement containing a ketone saltDietary supplement containing a ketone salt |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- • Provide voluntary signed and dated informed consent.
Key exclusion criteria (21 listed)
- Individuals using any kind of GLP-1 medications.
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 |
|---|---|---|
| Dietary Supplement containing Tri-betahydroxybutyrinKetone Tri Ester | Dietary supplement | 12.5mg Ketone Tri Ester |
| Dietary Supplement containing a ketone mono EsterKetone Mono Ester | Dietary supplement | 12.5mg Ketone Mono Ester |
| Dietary supplement containing a ketone saltDietary Supplement from a ketone salt | Dietary supplement | 12.5mg Ketone Salt |
Primary outcome
Serum BHB concentration maximum (Cmax)
Time frame: blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product
time to maximum concentration (Tmax)
Time frame: blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product
area under the curve (AUC),
Time frame: blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product
elimination half-life (T1/2),
Time frame: blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product
oral clearance
Time frame: blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product
volume of distribution
Time frame: blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product
2 secondary outcomes
Visual Analogue Scale for GI tolerance
Time frame: assessed at 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product
Safety (vital signs) and Adverse Events
Time frame: assessed at 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Tim Ziegenfuss, PhD principal investigator
CAHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement containing Tri-betahydroxybutyrin, Dietary Supplement containing a ketone mono Ester and Dietary supplement containing a ketone salt in people with Healthy Volunteer, run by NeuroEnergy Ventures, Inc. 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 10 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 17 Dec 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Serum BHB concentration maximum (Cmax) (time frame: blood draws will be performed before (0 min) and 15-, 30-, 45-, 60-, 90-, 120-, 150-, 180-, 240-, 300-, 360-, and 480 min post ingestion of the study product). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2025.