Ignite Creation Date:
2024-07-17 @ 10:40 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480760
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-24
Brief Title:
Effects of Carnosine In Patients With Peripheral Arterial Disease Patients
Sponsor:
Shahid Baba
Organization:
University of Louisville
Study Overview
Official Title:
Effects of Carnosine In Patients With Peripheral Arterial Disease Patients Randomized Intervention Trial CIPHER
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
CIPHER
Brief Summary:
The purpose of this study is to determine whether carnosine a food ingredient found in chicken and red meat supplementation 1 g for 6 months in subjects with peripheral arterial disease PAD non-claudication or claudication improves your walking ability Previous studies with heart failure patients had shown that carnosine supplementation increases walking capacity in these patients
Detailed Description:
The objectives of this double-blinded longitudinal study are to determine whether carnosine supplementation 1 g for 6 months in subjects with non-claudication and claudication peripheral arterial disease PAD improves walking ability In this pilot study there will be enrolled 120 subjects that will be divided into placebo n60 and carnosine groups n60 The distance covered on the 6-minute walk test 6-MWT and the pain free walking capacity on the treadmill before and after the placebo or carnosine supplementation will be measured Ankle branchial index ABI blood flow by magnetic resonance imaging MRI and laser doppler flowmetry LDF before and after the carnosine and placebo supplementation will be also measured In addition the carnosine will be measured by 1HMRS global metabolomics and proteomics in the skeletal muscle will be performed a comprehensive lipid and metabolic panels of blood will be performed uptake of carnosine in red blood cells RBCs will be measured and carnosine aldehyde conjugates in the urine before and after 6 months of carnosine and placebo supplementation will be evaluated Following completion of the study the subjects will be followed up for another 3 months and examine the durability of carnosine supplementation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None