Low-CArbohydrate Diet and SGLT2-INhibitOr to Achieve Moderate Ketosis in Healthy Volunteers

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

March 16, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Ketones, Metabolism
Interventions
DRUG

SGLT2 inhibitor

SGTL2i (15 mg) once daily

OTHER

Controlled, Adaptive Study Diet

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.

Trial Locations (1)

32804

AdventHealth Translational Research Institute, Orlando

All Listed Sponsors
lead

AdventHealth Translational Research Institute

OTHER