Clinical trial NCT00149149: Effect of Zinc Carnosine on Intestinal Permeability in Healthy Volunteers
Official title: Use of Zinc Carnosine on Intestinal Permeability in Healthy Volunteers Taking Non-steroidal Anti-inflammatory Drugs (NSAIDs)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Reduction in NSAID related gut damage
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Wexham GI Trust
First posted: 2005-09-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lactulose:rhamnose ratio - Arm1 (Urine)
timeFrame: day 5
measure: Lactulose:rhamnose ratio - Arm2 (Urine)
timeFrame: day 5
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College
Study officials:
affiliation: Imperial College London
name: Raymond Playford, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mahmood A, FitzGerald AJ, Marchbank T, Ntatsaki E, Murray D, Ghosh S, Playford RJ. Zinc carnosine, a health food supplement that stabilises small bowel integrity and stimulates gut repair processes. Gut. 2007 Feb;56(2):168-75. doi: 10.1136/gut.2006.099929. Epub 2006 Jun 15.