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Can a diet and drug combo safely boost ketones? small study aims to find out

NCT ID NCT05662865

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study is testing whether combining a low-carbohydrate diet with a diabetes drug (ertugliflozin) can safely produce moderate ketone levels in healthy adults. Nine participants will follow a gradually reducing carb diet while taking the drug, all under close supervision. The goal is to understand how the body responds, 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
ertugliflozin (SGLT2 inhibitor) and a low-carbohydrate diet
What this could lead to
If successful, this could help researchers understand how to safely achieve ketosis, potentially informing future treatments for metabolic conditions.
What could go wrong
This is a very small, early-phase study in healthy volunteers, so results may not apply to people with medical conditions. The diet and drug combination may cause side effects like dehydration or low blood sugar.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

9 people

The number who actually took part.

Started

Mar 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 60 years

Sex

Anyone

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: * M/F * Age 18-60 years * Weight stable (+/- 3 kg over past 6 months) * Body mass index (BMI): 21-35 kg/m2 * Otherwise healthy, as determined by medical history and laboratory tests * Understands the procedures and agrees to participate by giving written informed consent * Willing and able to comply with scheduled visits, laboratory tests, and other study procedures Exclusion criteria: Acute or chronic medical conditions or medication that would contraindicate the participation in the research testing or could potentially affect metabolic function including, but not limited to: 1. History or presence of cardiovascular disease (unstable angina, myocardial infarction or coronary revascularization within 6 months, presence of cardiac pacemaker, implanted cardiac defibrillator) 2. Diagnosis of type 1 or type 2 diabetes mellitus, or prior diabetic ketoacidosis 3. Blood pressure \> 140/90 mm Hg 4. Bleeding and clotting disorders 5. Acute or chronic infection (such as TB, HIV or Hepatitis) 6. Renal insufficiency (eGFR\<60), nephritis, or chronic kidney disease 7. Thyroid dysfunction (suppressed TSH, elevated TSH \<10 µIU/ml if symptomatic or elevated TSH \>10 µIU/ml if asymptomatic) 8. Liver disease (liver function tests \> 2 x normal; including NASH/NAFLD) 9. Gastrointestinal disorders (including inflammatory bowel disease or malabsorption, swallowing disorders, suspected or known strictures, fistulas or physiological/mechanical GI obstruction, history of gastrointestinal surgery, Crohn's disease or diverticulitis) 10. Past or present history of eating disorder (including binge eating) 11. Past or present history of psychiatric disease, including major depressive illness or bipolar disorder, as well as claustrophobia since part of the protocol will involve being confined to a small room for whole-body indirect calorimetry 12. Unwilling or unable to eat the foods provided in the study diet 13. A positive urine drug test for illicit drugs. 14. Any malignancy not considered cured, except basal cell carcinoma and squamous cell carcinoma of the skin (a participant is considered cured if there has been no evidence of cancer recurrence in the previous 5 years) 15. Pregnant or nursing females or females less than 6 months postpartum from the scheduled date of collection 16. Regular smoking or regular nicotine use of any kind including chewing tobacco, snuff and vaping 17. Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete study days. 18. History of regular alcohol consumption exceeding 7 drinks/week for female participants or 14 drinks/week for male participants (1 drink = 5 ounces \[150 mL\] of wine or 12 ounces \[360 mL\] of beer or 1.5 ounces \[45 mL\] of hard liquor) within 6 months before screening. 19. Donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pretrial (screening) visit. 20. Anemia (hemoglobin \<12 g/dl in men, \<11 g/dl in women) Excluded medications include, but are not limited to: 1. Any prescription medication or other drug that may influence metabolism (e.g. diet/weight-loss medication, psychiatric medications, corticosteroids, or other medications at the discretion of the PI and/or study team) 2. Anti-diabetic agents 3. Recent change to medication and/or dosing in the past 3 months 4. Blood thinner prescription medication 5. Chronic use of aspirin or other non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (a single aspirin daily if prescribed for cardioprotection will be allowed as will occasional use of aspirin and other non-steroidal drugs, provided that they are used for \< 3 consecutive days and not during the period of metabolic testing)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • AdventHealth Translational Research Institute

    Orlando, Florida, 32804, United States

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