Healthy
Conditions
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
Sponsors
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United Kingdom