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ACTIVE NOT RECRUITING
NCT05662865
PHASE1

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

Sponsor: AdventHealth Translational Research Institute

View on ClinicalTrials.gov

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.

Official title: Low-CArbohydrate Diet and SGLT2-INhibitOr to Achieve Moderate Ketosis in Healthy Volunteers (CASINO)

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

9

Start Date

2023-03-16

Completion Date

2026-12

Last Updated

2026-03-30

Healthy Volunteers

Yes

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.

Locations (1)

AdventHealth Translational Research Institute

Orlando, Florida, United States