Effect of Zinc Carnosine on Intestinal Permeability in Healthy Volunteers

What Was Tested

The trial (phase 1) is built around Carnosine.

Zinc carnosine is a food supplement which is available in the health food shops.

It had two arms (groups): Indomethacin treated volunteers (experimental) and Placebo treated volunteers (placebo comparator).

The registry classes the interventions as other.

More on the Plan

The study was about exploring the influence of zinc carnosine (ZnC) on changes in small bowel permeability caused by indomethacin.

Healthy volunteers (n = 10) participated in this double-blind randomised controlled crossover protocol.

Each arm comprised two baseline urine collections, followed by a third at the end of that study period.

All 10 participants completed the study without protocol violations.

Who Took Part

The registry lists 10 actual participants took part.

It was open to people of any sex aged from 18 years up to 35 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Aged 18-35 years.

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: conditions known to alter intestinal permeability, eg previous bowel surgery, celiac disease; conditions where nsaids are contraindicated, eg asthma, renal failure, heart failure; any other serious illness.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

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

Each person switched between Carnosine and the comparison at some point, usually with a gap in between.

Neither the participants nor the staff measuring them knew who was on Carnosine, so expectations could not easily colour the readings.

It started in 2005-05-01 with completion listed for 2006-05-18.

It ran at 1 site in United Kingdom.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Lactulose:rhamnose ratio - Arm1 (Urine) (time frame: day 5). Lactulose:rhamnose ratio - Arm2 (Urine) (time frame: day 5).

What This Means in Plain Language

Put simply, this is a phase 1, 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.