Carnosine for Peripheral Arterial Disease Patients

NCT05371145 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 22.0098
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Oral supplementation of L-carnosine will increase muscle carnosine, stabilize HIF1-alpha promote angiogenesis, and thus improve the functioning of lower extremities in PAD patients.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Carnosine for Peripheral Arterial Disease patients

  Compare the effects of carnosine supplementation on the 6-minute walk test (6MWT) at the baseline and after three months of carnosine supplementation. Measure the total walking distance and compare the walking distance covered by the subjects at the start and completion of carnosine supplementation

  One year

Secondary Outcomes (1)

• Graded treadmill test

  one year

Study Arms (1)

Carnosine intervention for patients with PAD

EXPERIMENTAL

This is a single arm open labelled safety trial, where we will supplement carnosine for 3 months to subjects with non-claudication and claudication peripheral arterial disease (PAD), and determine if it improves walking ability.

Biological: Carnosine

Interventions

Carnosine BIOLOGICAL

Determine whether carnosine supplementation (2 g/day) for 3 months in peripheral arterial disease patients improves 6MWT ability.

Carnosine intervention for patients with PAD

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male subjects more than \>50 to \<80 years of age.
• White or African American race.
• English Speaking.
• ABI 0.4-\< 0.60
• Willing to comply with protocol requirements.
• Able to provide informed consent. -

You may not qualify if:

• Subjects with HIV, hepatitis, significant liver disease, active infection, anemia, organ transplant, renal disease requiring dialysis, lung disease requiring oxygen, significant congenital heart disease, cancer of any type, and untreated thyroid disease.
• Diagnosis of carnosinemia.
• Known allergy to L-carnosine or meat.
• Presence of a pacemaker.
• Obesity from a known genetic defect.
• Dementia.
• Critical limb ischemia with below or above knee amputations.
• Foot ulcers.
• Major amputations.
• Participating in other clinical trials.
• End stage renal disease.
• Presence of significant injury within 30 days before enrollment.
• Prisoners.
• Any metallic implants.
• Poorly controlled diabetes (HbA1C \>9%) -

Sponsors & Collaborators

• Shahid Baba: lead

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

Related Publications (10)

• Annex BH. Therapeutic angiogenesis for critical limb ischaemia. Nat Rev Cardiol. 2013 Jul;10(7):387-96. doi: 10.1038/nrcardio.2013.70. Epub 2013 May 14.

  PMID: 23670612 RESULT

• Hiatt WR, Hoag S, Hamman RF. Effect of diagnostic criteria on the prevalence of peripheral arterial disease. The San Luis Valley Diabetes Study. Circulation. 1995 Mar 1;91(5):1472-9. doi: 10.1161/01.cir.91.5.1472.

  PMID: 7867189 RESULT

• Criqui MH, Aboyans V. Epidemiology of peripheral artery disease. Circ Res. 2015 Apr 24;116(9):1509-26. doi: 10.1161/CIRCRESAHA.116.303849.

  PMID: 25908725 RESULT

• Lombardi C, Carubelli V, Lazzarini V, Vizzardi E, Bordonali T, Ciccarese C, Castrini AI, Dei Cas A, Nodari S, Metra M. Effects of oral administration of orodispersible levo-carnosine on quality of life and exercise performance in patients with chronic heart failure. Nutrition. 2015 Jan;31(1):72-8. doi: 10.1016/j.nut.2014.04.021. Epub 2014 May 10.

  PMID: 25287762 RESULT

• Drozak J, Veiga-da-Cunha M, Vertommen D, Stroobant V, Van Schaftingen E. Molecular identification of carnosine synthase as ATP-grasp domain-containing protein 1 (ATPGD1). J Biol Chem. 2010 Mar 26;285(13):9346-9356. doi: 10.1074/jbc.M109.095505. Epub 2010 Jan 22.

  PMID: 20097752 RESULT

• Teufel M, Saudek V, Ledig JP, Bernhardt A, Boularand S, Carreau A, Cairns NJ, Carter C, Cowley DJ, Duverger D, Ganzhorn AJ, Guenet C, Heintzelmann B, Laucher V, Sauvage C, Smirnova T. Sequence identification and characterization of human carnosinase and a closely related non-specific dipeptidase. J Biol Chem. 2003 Feb 21;278(8):6521-31. doi: 10.1074/jbc.M209764200. Epub 2002 Dec 6.

  PMID: 12473676 RESULT

• Hipkiss AR. Energy metabolism, proteotoxic stress and age-related dysfunction - protection by carnosine. Mol Aspects Med. 2011 Aug;32(4-6):267-78. doi: 10.1016/j.mam.2011.10.004. Epub 2011 Oct 15.

  PMID: 22020113 RESULT

• Harris RC, Stellingwerff T. Effect of beta-alanine supplementation on high-intensity exercise performance. Nestle Nutr Inst Workshop Ser. 2013;76:61-71. doi: 10.1159/000350258. Epub 2013 Jul 25.

  PMID: 23899755 RESULT

• Caruso J, Charles J, Unruh K, Giebel R, Learmonth L, Potter W. Ergogenic effects of beta-alanine and carnosine: proposed future research to quantify their efficacy. Nutrients. 2012 Jul;4(7):585-601. doi: 10.3390/nu4070585. Epub 2012 Jun 26.

  PMID: 22852051 RESULT

• Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM, Carnethon MR, Dai S, de Simone G, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Greenlund KJ, Hailpern SM, Heit JA, Ho PM, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, McDermott MM, Meigs JB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Rosamond WD, Sorlie PD, Stafford RS, Turan TN, Turner MB, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2011 update: a report from the American Heart Association. Circulation. 2011 Feb 1;123(4):e18-e209. doi: 10.1161/CIR.0b013e3182009701. Epub 2010 Dec 15.

  PMID: 21160056 RESULT

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Carnosine

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Dipeptides; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: In a single arm open labelled safety trial, we will supplement carnosine for 3 months to subjects with non-claudication and claudication peripheral arterial disease (PAD), and determine if it improves walking ability. In our pilot study, we will enroll 20 male subjects measure the distance covered on the 6-minute walk test and the pain free walking capacity on the treadmill before, at baseline, and three months after carnosine supplementation.

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 12, 2022
• Study Start: March 1, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)