Effect of Zinc Carnosine on Intestinal Permeability in Healthy Volunteers

October 6, 2023 updated by: Imperial College London

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

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.).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Differences in dyspepsia score
Differences in faecal calprotectin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

Wexham GI Trust

Investigators

  • Principal Investigator: Raymond Playford, MD, PhD, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2005

Primary Completion (Actual)

May 18, 2006

Study Completion (Actual)

May 18, 2006

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimated)

September 8, 2005

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05/Q0408/19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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