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NCT05924295 · ClinicalTrials.gov registry record · NA
Variations in Ketone Metabolism
A NA study of Ketosis, sponsored by Ohio State University.
- Recruiting
- Registry status
- NA
- Development phase
- 400
- Enrollment target
- 2
- Study locations
NCT05924295 is a NA study of Ketosis that is actively recruiting participants, run by Ohio State University. The registered enrollment target is 400 participants, above the 31-participant average among 4 other Ketosis trials with a reported enrollment target (1190% higher). The trial reports 2 study locations across 2 states.
The verdict
NCT05924295, a NA study of Ketosis, is actively recruiting participants, sponsored by Ohio State University.
- RECRUITING
- Registry status
- NA
- Development phase
- 400 participants
- Enrollment target
- 2
- Study locations
Study Summary
This outcome of this study will elucidate how the phenotype of the individual modulates the KE metabolic effect. Most studies of KE have been in homogenous populations, usually young, male athletes. However, two striking experiments using identical, body weight adjusted KE doses in healthy and obese individuals found that BHB area under the curve (AUC) and removal was reduced by obesity and poor metabolic health. Similarly, ketone infusion experiments found that diabetes, obesity, and insulin resistance alter BHB metabolism. It is important to determine how obesity affects KE 'sensitivity' (i.e., breakdown and oxidation) because the increasing prevalence of obesity as a function of age. Age may be another important source of variation in ketone metabolism. The genes that control the ketone system are regulated by a cascade of transcription factors and hormones including PPARα and FGF21, which are themselves known to be affected by aging and dietary status, and the cellular protein sensor target of rapamycin (TOR). Aberrant hyperactivation of TOR with aging may reduce ketogenesis, while it was observed that a long-term ketogenic diet specifically up-regulated PPARα activity. Preliminary work revealed substantial changes across mouse lifespan in the expression of ketone-related genes in the liver such as Hmgcs2 (rate limiting for ketone production) and Bdh1 (rate limiting for BHB oxidation) between young, middle-aged, and old mice, with a nadir of gene expression in middle age before increasing again late in life. Substantial age differences were found in response to matched doses of oral KE in mice and in rats. These data may have important implications for treating people of different ages and for translating KE technologies into the Department of VA. Therefore, this project plans to study individual responses to KE ingestion across the lifespan, against the background of varying metabolic health
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Ketone Supplement
- BEHAVIORAL Beverage Tolerability Questionnaire (BTQ) and satiety visual analogue scale
- BIOLOGICAL Blood Draw
- OTHER Urine Analysis
Study Locations (2)
California
- The Buck Institute - Novato
Ohio
- The Ohio State University - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2023-06-20 |
| Est. Completion | 2027-01-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05924295
The ClinicalTrials.gov registry entry for NCT05924295 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 31-participant average among 4 other Ketosis trials with a reported enrollment target (1190% higher). 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 4 interventions - of which Ketone Supplement is the first listed.
NCT05924295 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Ohio.
Frequently Asked Questions
What is clinical trial NCT05924295 about?
NCT05924295 is a clinical study titled "Variations in Ketone Metabolism". This outcome of this study will elucidate how the phenotype of the individual modulates the KE metabolic effect. Most studies of KE have been in homogenous populations, usually young, male athletes. However, two striking experiments using identical, body weight adjusted KE doses in healthy and obese...
What is the current status of trial NCT05924295?
This trial is currently recruiting. It is a NA study. The enrollment target is 400 participants. The study started on 2023-06-20. Estimated completion is 2027-01-01.
What conditions does trial NCT05924295 study?
This clinical trial studies the following conditions: Ketosis.
What interventions are being tested in trial NCT05924295?
The interventions under investigation include: Ketone Supplement (DIETARY_SUPPLEMENT), Beverage Tolerability Questionnaire (BTQ) and satiety visual analogue scale (BEHAVIORAL), Blood Draw (BIOLOGICAL), Urine Analysis (OTHER).
Who is sponsoring clinical trial NCT05924295?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05924295 being conducted?
This trial has 2 study locations across California, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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