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Effect of Zinc Carnosine on Intestinal Permeability in Healthy Volunteers

Use of Zinc Carnosine on Intestinal Permeability in Healthy Volunteers Taking Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00149149
Enrollment
10
Registered
2005-09-08
Start date
2005-05-01
Completion date
2006-05-18
Last updated
2023-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Reduction in NSAID related gut damage

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.

Interventions

OTHERZinc Carnosine coadministered with Indomethacin
OTHERPlacebo coadministered with Indomethacin

Sponsors

Wexham GI Trust
CollaboratorUNKNOWN
Imperial College London
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE

Intervention model description

Zinc carnosine or placebo for 7 days with 5 days of indomethacin from days 2-7. It was a cross over protocol with 2 week washout inbetween.

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026