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Carnosine for Peripheral Arterial Disease Patients
Plain-language guide to NCT05371145: phase 1, phase 2 interventional trial of Carnosine, 20 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05371145
- Phase
- phase 1, phase 2
- Status
- status unknown
- Start
- 2023-03-01
- Completion (planned or actual)
- 2024-12-30
- Participants
- 20 (estimated)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Peripheral Arterial Disease
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1, phase 2) is built around Carnosine.
It had 1 arm (groups): Carnosine intervention for patients with PAD (experimental).
The registry classes the interventions as biological.
More on the Plan
PAD is diagnosed by calculating the ratio of blood pressure at the ankle to that of the arm (the ankle-brachial index \[ABI\]).
An ABI of \<0.90 is indicative of atherosclerosis in the leg.
Although surgical revascularization is an available treatment, grafts can fail and the stenosis can reoccur in these patients.
Who Took Part
Enrollment: 20 planned participants were the target.
It was open to men only aged from 50 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Male subjects more than \>50 to \<80 years of age. White or African American race. ABI 0.4-\< 0.60. Willing to comply with protocol requirements. Able to provide informed consent. -.
The full record lists 6 inclusion and 15 exclusion criteria; among the exclusions: diagnosis of carnosinemia; known allergy to l-carnosine or meat; presence of a pacemaker.
How the Study Was Run
The set-up was single-group and open-label.
Everyone knew when Carnosine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2023-03-01 with completion listed for 2024-12-30.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Carnosine for Peripheral Arterial Disease patients (time frame: One year).
It also tracked 1 secondary outcome, for example Graded treadmill test.
What This Means in Plain Language
Put simply, this is a phase 1, phase 2 trial of Carnosine in 20 people.
Its size is small, so on its own it can only give an early look.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Carnosine compound page, all human trials.
Our Notes on the Compound
Carnosine: A dipeptide of beta-alanine and histidine found in muscle and brain; studied as a supplement in human trials.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.