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NCT05662865 · ClinicalTrials.gov registry record · Phase 1
Low-CArbohydrate Diet and SGLT2-INhibitOr to Achieve Moderate Ketosis in Healthy Volunteers
A Phase 1 study of Ketones, Metabolism, sponsored by AdventHealth Translational Research Institute.
- Active
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT05662865: Active Phase 1 study of Ketones, Metabolism, sponsored by AdventHealth Translational Research Institute.
NCT05662865 is a Phase 1 study of Ketones, Metabolism that is active but no longer recruiting, run by AdventHealth Translational Research Institute. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05662865, a Phase 1 study of Ketones, Metabolism, is active but no longer recruiting, sponsored by AdventHealth Translational Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG SGLT2 inhibitor
- OTHER Controlled, Adaptive Study Diet
Study Locations (1)
Florida
- AdventHealth Translational Research Institute - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2023-03-16 |
| Est. Completion | 2025-12 |
| Phase | Phase 1 |
What the registry record for NCT05662865 still lists
NCT05662865 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Ketones, Metabolism appearing as the primary indexed condition, and to 2 interventions - of which SGLT2 inhibitor is the first listed.
NCT05662865 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05662865 about?
NCT05662865 is a clinical study titled "Low-CArbohydrate Diet and SGLT2-INhibitOr to Achieve Moderate Ketosis in Healthy Volunteers". 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.
What is the current status of trial NCT05662865?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2023-03-16. Estimated completion is 2025-12.
What conditions does trial NCT05662865 study?
This clinical trial studies the following conditions: Ketones, Metabolism.
What interventions are being tested in trial NCT05662865?
The interventions under investigation include: SGLT2 inhibitor (DRUG), Controlled, Adaptive Study Diet (OTHER).
Who is sponsoring clinical trial NCT05662865?
This trial is sponsored by AdventHealth Translational Research Institute, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05662865 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ketones, Metabolism
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05662865's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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