Effect of Zinc Carnosine on Intestinal Permeability in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Other: Zinc Carnosine coadministered with Indomethacin; Other: Placebo coadministered with Indomethacin

• Registration Number: NCT00149149
• Lead Sponsor: Imperial College London

Brief Summary

Zinc carnosine is a food supplement which is available in the health food shops. The investigators wish to see if it can reduce intestinal swelling in people who take non-steroidal anti-inflammatory (anti-swelling) drugs (NSAIDs: non-steroidal antiinflammatory drug.).

Detailed Description

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. In each arm, volunteers took ZnC (37.5 mg twice daily, orally) or placebo for 7 days, with indomethacin for the final 5 days.

Results were expressed as lactulose:rhamnose (L:R) ratios and mean values for each stage were therefore estimated: when taking placebo, volunteers had a threefold increase in L:R ratios in response to indomethacin administration (p,0.01), whereas no increase was seen if ZnC was also being taken.

All 10 participants completed the study without protocol violations. Two of ten participants developed mild nondescript upper abdominal discomfort while taking the indomethacin (control) arm, but completed the course. None reported symptoms during the ZnC (plus indomethacin) arm, and no side effects due to ingestion of ZnC were reported.

Study Timeline

• Study Start: 2005-05-01
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-08
• Primary Completion: 2006-05-18
• Study Completion: 2006-05-18
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-06
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Aged 18-35 years

Exclusion Criteria

• Conditions known to alter intestinal permeability, eg previous bowel surgery, celiac disease
• Conditions where NSAIDs are contraindicated, eg asthma, renal failure, heart failure
• Diabetes
• Any other serious illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Indomethacin treated volunteers	Zinc Carnosine coadministered with Indomethacin	5d of indomethacin treatment (50 mg t.i.d) with ZnC (37.5 mg b.i.d) coadministration.
Placebo treated volunteers	Placebo coadministered with Indomethacin	5 days of indomethacin treatment (50 mg t.i.d) with placebo coadministration.

Primary Outcome Measures

Name	Time	Method
Lactulose:rhamnose ratio - Arm1 (Urine)	day 5	Lactulose:rhamnose urine ratio in zinc carnosine/indomethacin coadministered patients
Lactulose:rhamnose ratio - Arm2 (Urine)	day 5	Lactulose:rhamnose urine ratio in placebo/indomethacin coadministered patients

Trial Locations

Locations (1)

Imperial College; 🇬🇧 London, United Kingdom