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

Phase 1

Active, not recruiting

• Conditions: Ketones, Metabolism
• Interventions: Drug: SGLT2 inhibitor; Other: Controlled, Adaptive Study Diet

• Registration Number: NCT05662865
• Lead Sponsor: AdventHealth Translational Research Institute

Brief 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.

Study Timeline

• Study First Submitted: 2022-12-15
• Study First Submitted QC: 2022-12-15
• Study First Posted: 2022-12-23
• Study Start: 2023-03-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-04
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Single, Experimental Group	SGLT2 inhibitor	SGLT2i + adaptive study diet of progressive dietary carbohydrate reduction
Single, Experimental Group	Controlled, Adaptive Study Diet	SGLT2i + adaptive study diet of progressive dietary carbohydrate reduction

Primary Outcome Measures

Name	Time	Method
Fasting ketones	28 days	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.

Secondary Outcome Measures

Name	Time	Method
24h AUC plasma ketones	28 days	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.

Trial Locations

Locations (1)

AdventHealth Translational Research Institute; 🇺🇸 Orlando, Florida, United States