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OpenTrials
Completed

NCT Number: NCT00149149

Effect of Zinc Carnosine on Intestinal Permeability in Healthy Volunteers

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.).

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Key information

Conditions

Healthy

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Imperial College

London, W12 0NN, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zinc Carnosine coadministered with Indomethacin

Other

Placebo coadministered with Indomethacin

Other

Primary outcomes

  1. Lactulose:rhamnose ratio - Arm1 (Urine)

    Time frame: day 5

    Lactulose:rhamnose urine ratio in zinc carnosine/indomethacin coadministered patients

  2. Lactulose:rhamnose ratio - Arm2 (Urine)

    Time frame: day 5

    Lactulose:rhamnose urine ratio in placebo/indomethacin coadministered patients

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Wexham GI Trust

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 8, 2005
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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