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NCT06977854 · ClinicalTrials.gov registry record
The Objective of This Study Was to Compare and Quantify the Bioavailability of Citrulline Byproducts in Blood Samples and in Urine Samples After a Single Dose of the Assigned Dietary Supplement. The Treatment Arms Containing the Following Molecules: Citrulline HCL and L-Citrulline,
A clinical trial, sponsored by Vireo Systems.
- Completed
- Registry status
- 32
- Enrollment target
NCT06977854 is a clinical trial that has completed, run by Vireo Systems. The registered enrollment target is 32 participants.
The verdict
NCT06977854 has completed, sponsored by Vireo Systems.
- COMPLETED
- Registry status
- 32 participants
- Enrollment target
Study Summary
Citrulline dietary supplements are of interest for improving cardiovascular and exercise performance. The health benefits of citrulline are attributable to its ability to increase arginine levels in the body through the intestinal-renal arginine conversion pathway. From a dietary supplementation standpoint, citrulline offers advantages over arginine due to its reduced first-pass metabolism and ready conversion to arginine within the body. While L-citrulline is the most widely used citrulline dietary supplement, additional salt forms such as citrulline maleate and citrulline HCl may provide improvements in the delivery of arginine to the body. The present study compared the single-dose pharmacokinetics of L-citrulline and citrulline HCl formulations in healthy human subjects. A total of 17 subjects were randomly assigned to groups receiving either 6 g of L-citrulline, 6 g of citrulline HCl or 2 g of citrulline HCl. The resulting increases in citrulline and arginine in plasma and urine samples were determined using liquid chromatography-multiple reaction monitoring mass spectrometry (LC-MRM/MS). All citrulline dietary supplements examined produced time-dependent increases in plasma citrulline and arginine. Both maximal plasma concentration (Cmax) and area under the plasma vs time curve (AUC) for citrulline were modestly reduced in the 6 g citrulline HCl treatment group, the resulting arginine Cmax and AUCs were similar for both L-citrulline and citrulline HCl at the 6 g dose. While the 2 g dose of citrulline HCl had reduced Cmax and AUC values compared to 6 g doses, the time to reach peak levels of arginine were significantly shorter. Furthermore, examination of the relative arginine bioavailability achieved with the 6 g and 2 g citrulline HCl compared to the 6 g L-citrulline was approximately 120% and 215%, respectively, consistent with an improved citrulline to arginine conversion efficiency with the citrulline HCl formulations.
Interventions
- OTHER Removal from study. In case of adverse event, subject treated for the AE.
- OTHER removal from study
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2024-07-13 |
| Est. Completion | 2024-07-27 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06977854
The ClinicalTrials.gov registry entry for NCT06977854 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vireo Systems, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Removal from study. In case of adverse event, subject treated for the AE. is the first listed.
NCT06977854 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06977854 about?
NCT06977854 is a clinical study titled "The Objective of This Study Was to Compare and Quantify the Bioavailability of Citrulline Byproducts in Blood Samples and in Urine Samples After a Single Dose of the Assigned Dietary Supplement. The Treatment Arms Containing the Following Molecules: Citrulline HCL and L-Citrulline,". Citrulline dietary supplements are of interest for improving cardiovascular and exercise performance. The health benefits of citrulline are attributable to its ability to increase arginine levels in the body through the intestinal-renal arginine conversion pathway. From a dietary supplementation sta...
What is the current status of trial NCT06977854?
This trial is currently completed. The enrollment target is 32 participants. The study started on 2024-07-13. Estimated completion is 2024-07-27.
What interventions are being tested in trial NCT06977854?
The interventions under investigation include: Removal from study. In case of adverse event, subject treated for the AE. (OTHER), removal from study (OTHER).
Who is sponsoring clinical trial NCT06977854?
This trial is sponsored by Vireo Systems, which has 3 total clinical trials registered on ClinicalTrials.gov.
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