Effect of Zinc Carnosine on Intestinal Permeability in Healthy Volunteers

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Imperial College London

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Other: Placebo coadministered with Indomethacin
Other: Zinc Carnosine coadministered with Indomethacin

Study type

Interventional

Funder types

Other

Identifiers

NCT00149149
05/Q0408/19

Details and patient eligibility

About

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.).

Full 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.

Enrollment

10 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

10 participants in 2 patient groups, including a placebo group

Indomethacin treated volunteers
Experimental group
Description:
5d of indomethacin treatment (50 mg t.i.d) with ZnC (37.5 mg b.i.d) coadministration.
Treatment:
Other: Zinc Carnosine coadministered with Indomethacin
Placebo treated volunteers
Placebo Comparator group
Description:
5 days of indomethacin treatment (50 mg t.i.d) with placebo coadministration.
Treatment:
Other: Placebo coadministered with Indomethacin

Trial contacts and locations

1

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Central trial contact

Asif Mahmood, MD

Data sourced from clinicaltrials.gov

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