Healthy VolunteerNCT07158645
A Study to Assess Human Pharmacokinetics of a Medical Food Containing Tri-betahydroxybutyrin
A study testing Medical Food Tri-betahydroxybutyrin in people with Healthy Volunteer, run by NeuroEnergy Ventures, Inc. at 1 site in United States.
Trial summary
The objective of this clinical trial is to obtain PK information following the acute intake of a medical food containing tri-betahydroxybutyrin (3BHB) in 18 healthy male subjects. Read more about this study
- Who is it for?
- Ages 60 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Medical Food Tri-betahydroxybutyrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2017to 22 Nov 2017
- 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 60 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Subject is a generally healthy male at least 60 years of age.
- 2. Subject has at least a high school diploma or the equivalent.
- 3. Subject has a score of 7 to 10 on the Vein Access Scale at Visit 1 (day -7).
- 4. Subject has a BMI of 18.5 and 29.9 kg/m2, inclusive at Visit 1 (day -7).
- 5. Subject is willing to remain on a stable dose of prescription medications within 30 d prior to Visit 1 (day -7) and throughout the study period.
- 6. Subject is willing to avoid alcohol and intentional exercise 24 h prior to Visit 2 (day 0) and throughout the study period.
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- 7. Subject is willing to maintain habitual diet, physical activity patterns, and body weight throughout the trial.
- 8. Subject is willing and able to comfortably abstain from caffeine prior to (10-14 h, target 12 h) and throughout the duration of all clinic visits (up to 14 h on Visit 2; day 0). (This is not a threat to validity to cognitive function; only possible alertness.)
- 9. Subject is a non-user of all 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 Visit 1 (day -7) and has no plans to change status during the study period.
- 10. Subject is willing and able to comply with the visit schedule.
- 11. 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, physical examination findings, and routine laboratory test results.
- 12. 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 is female.
- Subject has a fasting glucose greater than 125 mg/dL at Visit 1 (day -7). No retest allowed.
- Subject has abnormal laboratory test results of clinical significance at Visit 1 (day -7) on the basis of age and gender specific reference values and/or at the discretion of the Clinical Investigator, who has MD qualifications. One re-test will be allowed on a separate day prior to Visit 2 (day 0), for subjects with abnormal laboratory test results.
- Subject has a known allergy or sensitivity to any of the ingredients in the study products and/or any ingredients of the meals provided.
- Subject has any signs or symptoms of an active infection of clinical relevance (e.g., urinary tract or respiratory) within 5 d prior to Visit 2 (day 0). If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have resolved (at the discretion of the Clinical Investigator) and any treatment (e.g., antibiotic therapy) has been completed at least 5 d prior to testing.
- Subject experiences evidence of delirium, confusion, or other disturbances of consciousness.
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- Subject has a history of diagnosed depression in the prior 2 years of Visit 1 (day -7).
- Subject has any diagnosed neurologic disorder that could produce cognitive deterioration including, but not limited to, Alzheimer's disease, Parkinson's disease, stroke, intracranial hemorrhage, local brain lesions including tumors, and normal pressure hydrocephalus.
- Subject has a history of any infective or inflammatory brain disease, including those of viral, fungal, or syphilitic etiologies.
- Subject has a history of repeated minor head injury (e.g., in boxing) or a single injury resulting in a period of unconsciousness for 1 h or more.
- Subject has a history or presence of any acutely unstable medical condition, behavioral, and/or psychiatric disorder or surgical history that could affect the safety of the subject or interfere with study efficacy, safety, PK assessments, or the ability of the subject to complete the trial per the judgment of the Clinical Investigator (has MD qualifications).
- Subject has a history or presence of clinically important endocrine (including hyperparathyroidism, type 1 or 2 diabetes mellitus and/or hypoglycemia), cardiovascular (including, but not limited to history of myocardial infarction, peripheral arterial disease, stroke), pulmonary (including uncontrolled asthma), hepatic, renal, gastrointestinal, hematologic, immunologic, dermatologic, rheumatic (including gout), and/or biliary, that, in the opinion of the Clinical Investigator (has MD qualifications), could interfere with the interpretation of the study results.
- Subject has had a loss of 400 mL of blood (e.g., blood/plasma donation) during the prior 30 d of visit 2 (day 0).
- Subject has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer.
- Subject has a history of bariatric surgery for weight reducing purposes within the past year.
- Subject has recently (within 6 months prior to Visit 1; day -7) had a weight loss or gain >4.5 kg.
- Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) as defined by the blood pressure measured at Visit 1 (day -7). One re-test will be allowed on a separate day prior to Visit 2 (day 0), for subjects with abnormal blood pressure.
- Subject has extreme dietary habits (e.g., Atkins diet, very high protein, vegetarian, ketogenic diet, calorie deprivation), in the opinion of the Clinical Investigator.
- Subject has used any foods and/or dietary supplements containing medium chain triglycerides (MCT) with 30 d prior to Visit 1 (day -7).
- Subject has been exposed to any non-registered drug product within 30 d prior to Visit 1 (day -7).
- Subject has a recent history of (within 12 months of screening; Visit 1; day -7) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
BioFortis Innovative Services
Addison, Illinois, 60101
About this study
The objective of this clinical trial is to obtain PK information following the acute intake of a medical food containing tri-betahydroxybutyrin (3BHB) in 18 healthy male subjects. Blood samples will be obtained for the PK analysis of beta-hydroxybutyrate and acetoacetate at t = 1 and 2 h ± 5 min, where t = 0 h is the start of study product consumption. Subjects will be administered a standard breakfast immediately following the t = 2 h blood draw. Subjects will consume the breakfast meal within 30 min and will be instructed to eat until comfortably full.
Blood samples will be obtained via the indwelling venous catheter or venipuncture at t = 3, 4, 6, 8, and 12 h ± 5 min, where t = 0 h is the start of study product consumption, for the PK analysis of beta-hydroxybutyrate and acetoacetate. Subjects will be administered a standard snack (immediately following the t = 4 h blood draw), a standard lunch (immediately following the t = 6 h blood draw) and a standard dinner (at t = 10 h) Subjects will consume the meals/snack within 30 min and will be instructed to eat until comfortably full. Following the final blood draw of Visit 2 (day 0) at t = 12 h ± 5 min, the catheter will be removed, AEs will be assessed and a standard snack will be administered for consumption prior to discharge from the clinic.
At Visit 3 (day 1), subjects will return to the clinic for clinic visit procedures (i.e., vital signs; review inclusion and exclusion criteria for relevant changes, and concomitant medication/supplement use review). AEs will be assessed and subjects will be queried about study instructions compliance. Blood samples will be obtained at t = 24 h ± 5 min (with backups) by venipuncture for the PK analysis of beta-hydroxybutyrate and acetoacetate, where t = 0 h is the time of study product consumption.
- Conditions
- Healthy Volunteer
- Being tested
- Medical Food Tri-betahydroxybutyrin
- Keywords
- pK Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Food Tri-betahydroxybutyrinOther
Also called Medical Food Containing Tri-betahydroxybutyrin
Medical Food Containing Tri-betahydroxybutyrin
| Study group | Role | What they receive |
|---|---|---|
| 20gTri-betahydroxybutyrin | Active comparator | Medical Food Containing 20g Tri-betahydroxybutyrin Receives: Other: Medical Food Tri-betahydroxybutyrin |
| 40g Tri-betahydroxybutyrin | Active comparator | Medical Food Containing 40g Tri-betahydroxybutyrin Receives: Other: Medical Food Tri-betahydroxybutyrin |
| 60g Tri-betahydroxybutyrin | Active comparator | Medical Food Containing 60g Tri-betahydroxybutyrin Receives: Other: Medical Food Tri-betahydroxybutyrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
Area under the curve (AUC) from pre-product consumption (t = -0.25 h) to 24 h (AUC-0.25-24h)
Measured: Baseline, Hour 1, Hour 2, Hour 3, Hour 4, Hour 6, Hour 8, Hour 12, Hour 24
Maximum plasma concentration (Cmax)
Measured: Baseline, Hour 1, Hour 2, Hour 3, Hour 4, Hour 6, Hour 8, Hour 12, Hour 24
Time to Cmax (Tmax)
Measured: Baseline, Hour 1, Hour 2, Hour 3, Hour 4, Hour 6, Hour 8, Hour 12, Hour 24
Elimination rate constant
Measured: Baseline, Hour 1, Hour 2, Hour 3, Hour 4, Hour 6, Hour 8, Hour 12, Hour 24
Half life (t1/2)
Measured: Baseline, Hour 1, Hour 2, Hour 3, Hour 4, Hour 6, Hour 8, Hour 12, Hour 24
Apparent oral clearance (CL/F)
Measured: Baseline, Hour 1, Hour 2, Hour 3, Hour 4, Hour 6, Hour 8, Hour 12, Hour 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start20 Jul 2017
- Primary completion22 Nov 2017
- Study completion22 Nov 2017
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
- Parallel groups
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158645
- Sponsor's protocol ID
- BIO-1708
- Status last verified
- Sep 2025
- First submitted
- 6 Aug 2025
- Last updated
- 8 Sep 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 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess Human Pharmacokinetics of a Medical Food Containing Tri-betahydroxybutyrin
- ClinicalTrials.gov ID
- NCT07158645
- Acronym / sponsor ID
- BIO-1708
- Conditions
- Healthy Volunteer
- Keywords
- pK Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- NeuroEnergy Ventures, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 22 Nov 2017 (actual)
- Study completion
- 22 Nov 2017 (actual)
- First posted
- 8 Sep 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 objective of this clinical trial is to obtain PK information following the acute intake of a medical food containing tri-betahydroxybutyrin (3BHB) in 18 healthy male subjects. Blood samples will be obtained for the PK analysis of beta-hydroxybutyrate and acetoacetate at t = 1 and 2 h ± 5 min, where t = 0 h is the start of study product consumption. Subjects will be administered a standard breakfast immediately following the t = 2 h blood draw. Subjects will consume the breakfast meal within 30 min and will be instructed to eat until comfortably full.
Blood samples will be obtained via the indwelling venous catheter or venipuncture at t = 3, 4, 6, 8, and 12 h ± 5 min, where t = 0 h is the start of study product consumption, for the PK analysis of beta-hydroxybutyrate and acetoacetate. Subjects will be administered a standard snack (immediately following the t = 4 h blood draw), a standard lunch (immediately following the t = 6 h blood draw) and a standard dinner (at t = 10 h) Subjects will consume the meals/snack within 30 min and will be instructed to eat until comfortably full. Following the final blood draw of Visit 2 (day 0) at t = 12 h ± 5 min, the catheter will be removed, AEs will be assessed and a standard snack will be administered for consumption prior to discharge from the clinic.
At Visit 3 (day 1), subjects will return to the clinic for clinic visit procedures (i.e., vital signs; review inclusion and exclusion criteria for relevant changes, and concomitant medication/supplement use review). AEs will be assessed and subjects will be queried about study instructions compliance. Blood samples will be obtained at t = 24 h ± 5 min (with backups) by venipuncture for the PK analysis of beta-hydroxybutyrate and acetoacetate, where t = 0 h is the time of study product consumption.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 20gTri-betahydroxybutyrin | Active comparator | Other: Medical Food Tri-betahydroxybutyrinMedical Food Containing 20g Tri-betahydroxybutyrin |
| 40g Tri-betahydroxybutyrin | Active comparator | Other: Medical Food Tri-betahydroxybutyrinMedical Food Containing 40g Tri-betahydroxybutyrin |
| 60g Tri-betahydroxybutyrin | Active comparator | Other: Medical Food Tri-betahydroxybutyrinMedical Food Containing 60g Tri-betahydroxybutyrin |
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1. Subject is a generally healthy male at least 60 years of age.
- 2. Subject has at least a high school diploma or the equivalent.
- 3. Subject has a score of 7 to 10 on the Vein Access Scale at Visit 1 (day -7).
- 4. Subject has a BMI of 18.5 and 29.9 kg/m2, inclusive at Visit 1 (day -7).
- 5. Subject is willing to remain on a stable dose of prescription medications within 30 d prior to Visit 1 (day -7) and throughout the study period.
Key exclusion criteria (22 listed)
- Subject is female.
- Subject has a fasting glucose greater than 125 mg/dL at Visit 1 (day -7). No retest allowed.
- Subject has abnormal laboratory test results of clinical significance at Visit 1 (day -7) on the basis of age and gender specific reference values and/or at the discretion of the Clinical Investigator, who has MD qualifications. One re-test will be allowed on a separate day prior to Visit 2 (day 0), for subjects with abnormal laboratory test results.
- Subject has a known allergy or sensitivity to any of the ingredients in the study products and/or any ingredients of the meals provided.
- Subject has any signs or symptoms of an active infection of clinical relevance (e.g., urinary tract or respiratory) within 5 d prior to Visit 2 (day 0). If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have resolved (at the discretion of the Clinical Investigator) and any treatment (e.g., antibiotic therapy) has been completed at least 5 d prior to testing.
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 |
|---|---|---|
| Medical Food Tri-betahydroxybutyrinAlso: Medical Food Containing Tri-betahydroxybutyrinMedical Food Containing Tri-betahydroxybutyrin | Other | 20gTri-betahydroxybutyrin, 40g Tri-betahydroxybutyrin, 60g Tri-betahydroxybutyrin |
Primary outcome
Primary Outcome
Time frame: Baseline, Hour 1, Hour 2, Hour 3, Hour 4, Hour 6, Hour 8, Hour 12, Hour 24
Area under the curve (AUC) from pre-product consumption (t = -0.25 h) to 24 h (AUC-0.25-24h)
Maximum plasma concentration (Cmax)
Time frame: Baseline, Hour 1, Hour 2, Hour 3, Hour 4, Hour 6, Hour 8, Hour 12, Hour 24
Time to Cmax (Tmax)
Time frame: Baseline, Hour 1, Hour 2, Hour 3, Hour 4, Hour 6, Hour 8, Hour 12, Hour 24
Elimination rate constant
Time frame: Baseline, Hour 1, Hour 2, Hour 3, Hour 4, Hour 6, Hour 8, Hour 12, Hour 24
Half life (t1/2)
Time frame: Baseline, Hour 1, Hour 2, Hour 3, Hour 4, Hour 6, Hour 8, Hour 12, Hour 24
Apparent oral clearance (CL/F)
Time frame: Baseline, Hour 1, Hour 2, Hour 3, Hour 4, Hour 6, Hour 8, Hour 12, Hour 24
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 8 Sep 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.
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 Medical Food Tri-betahydroxybutyrin 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 12 inclusion and 22 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 8 Sep 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?
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?
Primary Outcome (time frame: Baseline, Hour 1, Hour 2, Hour 3, Hour 4, Hour 6, Hour 8, Hour 12, Hour 24). 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 8 Sep 2025.