Ketones, MetabolismPhase 1CASINONCT05662865
Low-CArbohydrate Diet and SGLT2-INhibitOr to Achieve Moderate Ketosis in Healthy Volunteers
A Phase 1 study testing SGLT2 inhibitor in people with Ketones, Metabolism, run by AdventHealth Translational Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to help us better understand how plasma ketones respond to a low-carb diet when combined with an SGLT2 inhibitor. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Ketones, Metabolism
- What is being tested?
- SGLT2 inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2023to Dec 2026
- Phase
- Phase 1
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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:
- History or presence of cardiovascular disease (unstable angina, myocardial infarction or coronary revascularization within 6 months, presence of cardiac pacemaker, implanted cardiac defibrillator)
- Diagnosis of type 1 or type 2 diabetes mellitus, or prior diabetic ketoacidosis
- Blood pressure > 140/90 mm Hg
- Bleeding and clotting disorders
- Acute or chronic infection (such as TB, HIV or Hepatitis)
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- Renal insufficiency (eGFR<60), nephritis, or chronic kidney disease
- Thyroid dysfunction (suppressed TSH, elevated TSH <10 µIU/ml if symptomatic or elevated TSH >10 µIU/ml if asymptomatic)
- Liver disease (liver function tests > 2 x normal; including NASH/NAFLD)
- 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)
- Past or present history of eating disorder (including binge eating)
- 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
- Unwilling or unable to eat the foods provided in the study diet
- A positive urine drug test for illicit drugs.
- 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)
- Pregnant or nursing females or females less than 6 months postpartum from the scheduled date of collection
- Regular smoking or regular nicotine use of any kind including chewing tobacco, snuff and vaping
- 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.
- 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.
- Donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pretrial (screening) visit.
- Anemia (hemoglobin <12 g/dl in men, <11 g/dl in women)
- Excluded medications include, but are not limited to:
- 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)
- Anti-diabetic agents
- Recent change to medication and/or dosing in the past 3 months
- Blood thinner prescription medication
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
AdventHealth Translational Research Institute
Orlando, Florida, 32804
About this study
Official title: Low-CArbohydrate Diet and SGLT2-INhibitOr to Achieve Moderate Ketosis in Healthy Volunteers (CASINO)
The purpose of this study is to help us better understand how plasma ketones respond to a low-carb diet when combined with an SGLT2 inhibitor.
Read the detailed description
We will combine an SGLT2i with an adaptive study diet that gradually reduces dietary carbohydrates to safely achieve moderate ketosis in healthy adult volunteers.
- Conditions
- Ketones, Metabolism
- Being tested
- SGLT2 inhibitor, Controlled, Adaptive Study Diet
- Medical subject headings
- Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2 inhibitorDrug
Also called ertugliflozin
SGTL2i (15 mg) once daily
Controlled, Adaptive Study DietOther
An adaptive study diet combined with SGLT2i, which consists of four sequential, 7-day long phases in which dietary carbohydrates are gradually reduced (50% carbs, 30% carbs, 20% carbs, and 10% carbs) based on safety and tolerability to achieve moderate ketosis. All diet phases are isocaloric. All meals are provided on an inpatient unit.
| Study group | Role | What they receive |
|---|---|---|
| Single, Experimental Group | Experimental | SGLT2i + adaptive study diet of progressive dietary carbohydrate reduction Receives: Drug: SGLT2 inhibitor; Other: Controlled, Adaptive Study Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting ketones
To determine if the primary study objective was achieved (e.g. SGLT2i combined with dietary carbohydrate restriction achieves moderate ketosis, safely and tolerably, in healthy, non-diabetic adults), we will use a binary decision (yes/no) for each participant, based on fasting capillary ketones.
Measured: 28 days
Secondary outcomes (1)
24h AUC plasma ketones
The secondary objective of this study is to analyze changes in fasting and 24h AUC of plasma ketones (BHB and AcAc) between SGLT2i + standard-carb diet versus SGLT2i + low-carb/adaptive diet using within-subject repeated measures analysis of variance. A p-value less than 0.05 will be considered statistically significant.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start16 Mar 2023
- Primary completion23 Jul 2024
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ketones, MetabolismStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Proof-of-concept, single-group, study design
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth Translational Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa Erickson, PhD, Principal investigator, AdventHealth Translational Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662865
- Sponsor's protocol ID
- 1921572
- Acronym
- CASINO
- Status last verified
- Mar 2026
- First submitted
- 15 Dec 2022
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No