NCT05662865

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: AdventHealth Translational Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-03-16
• Primary completion: 2024-07-23
• Completion: 2026-12-01
• First posted: 2022-12-23
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States