Carnosine for Peripheral Arterial Disease

What Was Tested

In this phase 2 trial, researchers set out to test Carnosine.

Compare the effect of carnosine and placebo supplementation on the 6MWT in PAD patients with and without claudication.

It had two arms (groups): Carnosine (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

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: 10 actual participants took part.

It was open to people of any sex aged from 50 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Subjects between 50 and 80 years of age. ABI 0.3 -\<0.90 (in at least one leg). Willing to comply with protocol requirements. Able to provide informed consent. Able to walk on a treadmill for more than 2 minutes -.

The full record lists 6 inclusion and 15 exclusion criteria; among the exclusions: diagnosis of carnosinemia; known allergy to l-carnosine or meat; obesity from a known genetic defect.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Carnosine group and the comparison group should start out alike.

The Carnosine group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Carnosine.

Those kept unaware of assignments: participant and investigator.

It started in 2016-05-12 with completion listed for 2022-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Walking Endurance (time frame: 6 months).

It also tracked 1 secondary outcome, for example Graded treadmill test.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Carnosine in 10 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Carnosine compound page, all human trials.