Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00149149
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2005-09-07
Brief Title:
Effect of Zinc Carnosine on Intestinal Permeability in Healthy Volunteers
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
Use of Zinc Carnosine on Intestinal Permeability in Healthy Volunteers Taking Non-steroidal Anti-inflammatory Drugs NSAIDs
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 375 mg twice daily orally or placebo for 7 days with indomethacin for the final 5 days
Results were expressed as lactuloserhamnose LR ratios and mean values for each stage were therefore estimated when taking placebo volunteers had a threefold increase in LR ratios in response to indomethacin administration p001 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
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 375 mg twice daily orally or placebo for 7 days with indomethacin for the final 5 days
Results were expressed as lactuloserhamnose LR ratios and mean values for each stage were therefore estimated when taking placebo volunteers had a threefold increase in LR ratios in response to indomethacin administration p001 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None