Effect of Zinc Carnosine on Intestinal Permeability in Healthy Volunteers

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Other: Zinc Carnosine coadministered with Indomethacin
* Other: Placebo coadministered with Indomethacin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indomethacin treated volunteers<br>5d of indomethacin treatment (50 mg t.i.d) with ZnC (37.5 mg b.i.d) coadministration. | Other: Zinc Carnosine coadministered with Indomethacin<br> <br> |
| Placebo Comparator: Placebo treated volunteers<br>5 days of indomethacin treatment (50 mg t.i.d) with placebo coadministration. | Other: Placebo coadministered with Indomethacin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactulose:rhamnose ratio - Arm1 (Urine) | Lactulose:rhamnose urine ratio in zinc carnosine/indomethacin coadministered patients | day 5 | 
| Lactulose:rhamnose ratio - Arm2 (Urine) | Lactulose:rhamnose urine ratio in placebo/indomethacin coadministered patients | day 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reduction in NSAID related gut damage