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Medical food ingredient tested in 18 men – no cure, just data

NCT ID NCT07158645

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This completed study looked at how a medical food containing tri-betahydroxybutyrin is absorbed and cleared from the body. Eighteen healthy men aged 60 and older took a single dose and gave blood samples over 24 hours. The goal was simply to measure levels of certain substances in the blood, not to treat any disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tri-betahydroxybutyrin (a medical food ingredient)

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

18 people

The number who actually took part.

Started

Jul 2017

Finished

Nov 2017

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. 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. Exclusion Criteria: 1. Subject is female. 2. Subject has a fasting glucose greater than 125 mg/dL at Visit 1 (day -7). No retest allowed. 3. 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. 4. Subject has a known allergy or sensitivity to any of the ingredients in the study products and/or any ingredients of the meals provided. 5. 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. 6. Subject experiences evidence of delirium, confusion, or other disturbances of consciousness. 7. Subject has a history of diagnosed depression in the prior 2 years of Visit 1 (day -7). 8. 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. 9. Subject has a history of any infective or inflammatory brain disease, including those of viral, fungal, or syphilitic etiologies. 10. 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. 11. 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). 12. 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. 13. 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). 14. Subject has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer. 15. Subject has a history of bariatric surgery for weight reducing purposes within the past year. 16. Subject has recently (within 6 months prior to Visit 1; day -7) had a weight loss or gain \>4.5 kg. 17. 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. 18. Subject has extreme dietary habits (e.g., Atkins diet, very high protein, vegetarian, ketogenic diet, calorie deprivation), in the opinion of the Clinical Investigator. 19. Subject has used any foods and/or dietary supplements containing medium chain triglycerides (MCT) with 30 d prior to Visit 1 (day -7). 20. Subject has been exposed to any non-registered drug product within 30 d prior to Visit 1 (day -7). 21. 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). 22. 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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • BioFortis Innovative Services

    Addison, Illinois, 60101, United States

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