ACTIVE_NOT_RECRUITING

COMP-4 Supplementation and Brachial Artery FMD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

In a young and healthy person, the production of nitric oxide (NO) by the endothelium, the inner lining of the blood vessel, is responsible for a) the ability of the blood vessel to dilate so it can increase its blood flow and b) act as an anti-clotting product to prevent blood clotting in those vessels. Under physiological stress either due to the development of a disease such as diabetes or simply from aging, the endothelial cells can be impacted and become dysfunctional thereby impairing their ability to make NO and even promote the development of blood clots. When such endothelial dysfunction occurs, it may be a precursor for the future development of cardiovascular (CV) disease like hypertension or even coronary artery disease later on in life in these patients. Therefore, the ability to somehow enhance the local production or availability of NO within such affected blood vessels in patients identified as prone to endothelial dysfunction could play a positive role in either preventing or delaying the onset of endothelial dysfunction and subsequent CV disease in such patients. COMP-4 is a safe, clinically available, well tolerated oral supplement that has been shown in the lab to increase NO production in a number of differing tissues including human vascular endothelial cells. In this proposed human study, the investigators plan on recruiting healthy, young participants willing to take COMP-4 for a 14 day period in whom the investigators will measure in a non-invasive way - by the use of ultrasound - the effect of COMP-4 on its ability to improve blood flow in one of the major blood vessels of the upper arm. In addition, the investigators will also determine whether COMP-4 will be capable of lowering in the blood the levels of two of the most studied inflammatory markers associated with endothelial dysfunction, IL-8 and PAI-1.

Official Title

The Effect of Daily COMP-4 Supplementation on Brachial Artery Flow Mediated Dilation and Cellular Senescence Markers in Young and Healthy Individuals

Quick Facts

Study Start:2023-06-01
Study Completion:2026-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05595915

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.

Ages Eligible for Study:18 Years to 39 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * All men and women ages 18-39 will be offered the opportunity to participate in this study as long as they do not have a history of acute or chronic cardiovascular illnesses effecting flow mediated dilation.
  1. * Men and women with ages other than of 18-39 years of age;
  2. * Women who are currently pregnant;
  3. * Men and women with a history of serious cardiovascular events, those currently on blood pressure medications, and those with known allergies to any of the 4 components of COMP-4 (ginger, muira puama,Paullinia cupana, and L-citrulline)

Contacts and Locations

Principal Investigator

Sriram V. Eleswarapu, MD PhD
PRINCIPAL_INVESTIGATOR
University of California, Los Angeles

Study Locations (Sites)

UCLA
Los Angeles, California, 90034
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

  • Sriram V. Eleswarapu, MD PhD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

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 Registration Dates

Study Start Date2023-06-01
Study Completion Date2026-07-31

Study Record Updates

Study Start Date2023-06-01
Study Completion Date2026-07-31

Terms related to this study

Keywords Provided by Researchers

  • Flow Mediated Dilation
  • COMP-4
  • Endothelial (dys)function
  • Senescence

Additional Relevant MeSH Terms

  • Aging
  • Endothelial Dysfunction
  • Senescence