HealthyPhase 1NCT00149149
Effect of Zinc Carnosine on Intestinal Permeability in Healthy Volunteers
A Phase 1 study testing Zinc Carnosine coadministered with Indomethacin in people with Healthy, run by Imperial College London at 1 site in United Kingdom.
Trial 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.). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Zinc Carnosine coadministered with Indomethacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2005to 18 May 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-35 years
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.).
Read the 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.
- Conditions
- Healthy
- Being tested
- Zinc Carnosine coadministered with Indomethacin, Placebo coadministered with Indomethacin
- Keywords
- Reduction in NSAID related gut damage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc Carnosine coadministered with IndomethacinOther
Placebo coadministered with IndomethacinOther
| Study group | Role | What they receive |
|---|---|---|
| Indomethacin treated volunteers | Experimental | 5d of indomethacin treatment (50 mg t.i.d) with ZnC (37.5 mg b.i.d) coadministration. Receives: Other: Zinc Carnosine coadministered with Indomethacin |
| Placebo treated volunteers | Placebo comparator | 5 days of indomethacin treatment (50 mg t.i.d) with placebo coadministration. Receives: Other: Placebo coadministered with Indomethacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactulose:rhamnose ratio - Arm1 (Urine)
Lactulose:rhamnose urine ratio in zinc carnosine/indomethacin coadministered patients
Measured: day 5
Lactulose:rhamnose ratio - Arm2 (Urine)
Lactulose:rhamnose urine ratio in placebo/indomethacin coadministered patients
Measured: day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study start1 May 2005
- Primary completion18 May 2006
- Study completion18 May 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Wexham GI Trust
- Investigators
- Raymond Playford, MD, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149149
- Sponsor's protocol ID
- 05/Q0408/19
- Status last verified
- Oct 2023
- First submitted
- 7 Sep 2005
- Last updated
- 10 Oct 2023
- Results posted
- No
Publications
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.
PubMed 16777920
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Zinc Carnosine on Intestinal Permeability in Healthy Volunteers Taking Non-steroidal Anti-inflammatory Drugs (NSAIDs)
- ClinicalTrials.gov ID
- NCT00149149
- Acronym / sponsor ID
- 05/Q0408/19
- Conditions
- Healthy
- Keywords
- Reduction in NSAID related gut damage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Wexham GI Trust
- Study start
- 1 May 2005 (actual)
- Primary completion
- 18 May 2006 (actual)
- Study completion
- 18 May 2006 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Indomethacin treated volunteers | Experimental | Other: Zinc Carnosine coadministered with Indomethacin5d of indomethacin treatment (50 mg t.i.d) with ZnC (37.5 mg b.i.d) coadministration. |
| Placebo treated volunteers | Placebo comparator | Other: Placebo coadministered with Indomethacin5 days of indomethacin treatment (50 mg t.i.d) with placebo coadministration. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Aged 18-35 years
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc Carnosine coadministered with Indomethacin | Other | Indomethacin treated volunteers |
| Placebo coadministered with Indomethacin | Other | Placebo treated volunteers |
Primary outcome
Lactulose:rhamnose ratio - Arm1 (Urine)
Time frame: day 5
Lactulose:rhamnose urine ratio in zinc carnosine/indomethacin coadministered patients
Lactulose:rhamnose ratio - Arm2 (Urine)
Time frame: day 5
Lactulose:rhamnose urine ratio in placebo/indomethacin coadministered patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Results publication: PubMed 16777920Mahmood 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond Playford, MD, PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zinc Carnosine coadministered with Indomethacin in people with Healthy, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lactulose:rhamnose ratio - Arm1 (Urine) (time frame: day 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00149149, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.