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NCT05501366 · ClinicalTrials.gov registry record · NA
Strategies to Augment Ketosis: Optimization of Ketone Delivery Strategies
A NA study of Ketosis, sponsored by Ohio State University.
- Active
- Registry status
- NA
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT05501366 is a NA study of Ketosis that is active but no longer recruiting, run by Ohio State University. The registered enrollment target is 14 participants, below the 128-participant average among 4 other Ketosis trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05501366, a NA study of Ketosis, is active but no longer recruiting, sponsored by Ohio State University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
One important difference between KE compounds is the ketone-promoting components, which determines the circulating ratio of blood ketone bodies, BHB and AcAc, and may in turn lead to important metabolic and signaling differences. Whereas some actions of the ketone bodies BHB and AcAc are shared, R-BHB has a broad range of signaling functions that are distinct from AcAc, some of which are shared by the non-circulating, non-oxidizable enantiomer, S-BHB. AcAc also has metabolic and signaling actions that are independent of BHB and is selectively oxidized in some cells that cannot oxidize BHB. Furthermore, responses to different ketone bodies vary between tissue types. A second difference between KE arises from the balance between direct delivery of ketones compared to indirectly elevating ketone concentration via metabolism of non-classical or classical ketogenic precursors. Classical ketogenesis itself may drive adaptation and some of the functional benefits associated with ketosis. BDO is included in all of the KE compounds, but it is currently unknown how consumption of BDO alone, and its metabolism via non-classical ketogenesis acutely affects metabolism. Additionally, ketogenesis is now understood to occur in certain cells outside the liver with important local biological effects, for example ketogenesis driven by medium chain fatty acids has been reported in astrocytes in vitro. Provision of systemic BHB by a KE may elicit different biological effects in some tissues such as the brain versus promoting in situ ketogenesis in that tissue. Overall, not only are functional effects of KE incompletely defined, but also it is unknown which effects are common to all KE versus which are specific to an individual KE compound (i.e., BHB Monoester vs AcAc Diester) or which may be attributable to the BDO precursor common to all of the KE. This study will be the first comparative full crossover study of all available KE and the precursor BDO at two serving sizes. Outcomes will
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Ketone Supplement
- BEHAVIORAL Beverage Tolerability Questionnaire (BTQ) and satiety visual analogue scale
- BIOLOGICAL Blood Draw
- OTHER Breath Reading
- OTHER Heart Rate Variability
Study Locations (1)
Ohio
- The Ohio State University - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2023-06-05 |
| Est. Completion | 2027-09 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05501366
The ClinicalTrials.gov registry entry for NCT05501366 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 128-participant average among 4 other Ketosis trials with a reported enrollment target (89% lower). The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Ketosis appearing as the primary indexed condition, and to 5 interventions - of which Ketone Supplement is the first listed.
NCT05501366 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT05501366 about?
NCT05501366 is a clinical study titled "Strategies to Augment Ketosis: Optimization of Ketone Delivery Strategies". One important difference between KE compounds is the ketone-promoting components, which determines the circulating ratio of blood ketone bodies, BHB and AcAc, and may in turn lead to important metabolic and signaling differences. Whereas some actions of the ketone bodies BHB and AcAc are shared, R-B...
What is the current status of trial NCT05501366?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 14 participants. The study started on 2023-06-05. Estimated completion is 2027-09.
What conditions does trial NCT05501366 study?
This clinical trial studies the following conditions: Ketosis.
What interventions are being tested in trial NCT05501366?
The interventions under investigation include: Ketone Supplement (DIETARY_SUPPLEMENT), Beverage Tolerability Questionnaire (BTQ) and satiety visual analogue scale (BEHAVIORAL), Blood Draw (BIOLOGICAL), Breath Reading (OTHER), Heart Rate Variability (OTHER).
Who is sponsoring clinical trial NCT05501366?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05501366 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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