COMP-4 Supplementation and Brachial Artery FMD

NCT05595915 | Completed Phase 1

• 1 other identifier: IRB: 22-001158
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aging; Endothelial Dysfunction; Senescence

Keywords

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

Outcome Measures

Primary Outcomes (2)

• To study the effect of short-term use of daily COMP-4 on flow mediated dilation (FMD) of the brachial artery in young, generally healthy men and women.

  Flow Mediated Dilation (FMD) is a non-invasive procedure in which the response of the blood vessel to ischemia is measured. This procedure is mediated primarily by nitric oxide (NO). COMP-4 is a supplement that has been shown to increase NO availability. The investigators want to study whether COMP-4 will FMD compared to baseline.

  35 subjects in approx. 9 months

• To investigate whether, through reduction in oxidative stress, COMP-4 can lower PAI-1 and IL-8 levels

  PAI-1 and IL-8 are two serum markers that are highly associated with cellular senescence, referring to permanent exit of cells from the cell cycle. Cellular senescence is associated with advancing age, and nitric oxide (NO) is one of the mechanisms shown to cause senescence. In this study, the investigators want to evaluate whether COMP-4, a supplement shown to improve NO availability, can alleviate senescence by decreasing serum markers associated with it.

  35 subjects within approx. 9 months.]

Secondary Outcomes (1)

• To further evaluate for side effects of COMP-4 use

  35 subjects will take COMP-4 for 14 days

Study Arms (1)

Experimental Group

EXPERIMENTAL

All subjects recruited in this study will be in the experimental group receiving the oral supplement, COMP-4, twice daily for 14 days.

Dietary Supplement: COMP-4

Interventions

COMP-4 DIETARY_SUPPLEMENT

COMP-4 is a novel compound that consists of ginger extract, L-citrulline, and the herbal components Paullinia cupana and muira puama.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Men and women with ages other than of 18-39 years of age;
• Women who are currently pregnant;
• 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)

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA

Los Angeles, California, 90034, United States

Location

Related Publications (4)

• Whisner CM, Angadi SS, Weltman NY, Weltman A, Rodriguez J, Patrie JT, Gaesser GA. Effects of Low-Fat and High-Fat Meals, with and without Dietary Fiber, on Postprandial Endothelial Function, Triglyceridemia, and Glycemia in Adolescents. Nutrients. 2019 Nov 2;11(11):2626. doi: 10.3390/nu11112626.

  PMID: 31684015 BACKGROUND

• Haptonstall KP, Choroomi Y, Moheimani R, Nguyen K, Tran E, Lakhani K, Ruedisueli I, Gornbein J, Middlekauff HR. Differential effects of tobacco cigarettes and electronic cigarettes on endothelial function in healthy young people. Am J Physiol Heart Circ Physiol. 2020 Sep 1;319(3):H547-H556. doi: 10.1152/ajpheart.00307.2020. Epub 2020 Jul 31.

  PMID: 32734819 BACKGROUND

• Papamichael CM, Aznaouridis KA, Karatzis EN, Karatzi KN, Stamatelopoulos KS, Vamvakou G, Lekakis JP, Mavrikakis ME. Effect of coffee on endothelial function in healthy subjects: the role of caffeine. Clin Sci (Lond). 2005 Jul;109(1):55-60. doi: 10.1042/CS20040358.

  PMID: 15799717 BACKGROUND

• Nguyen S, Rajfer J, Shaheen M. Safety and efficacy of daily Revactin(R) in men with erectile dysfunction: a 3-month pilot study. Transl Androl Urol. 2018 Apr;7(2):266-273. doi: 10.21037/tau.2018.03.22.

  PMID: 29732286 BACKGROUND

Study Officials

• Sriram V. Eleswarapu, MD PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Urology

Model Details: The investigators plan to recruit 35 young men and women ages 18-40. All subjects will take COMP-4 twice a day for a total of 14 days, and FMD and senescence associated markers of PAI-1 and IL-8 will be measured on day 0 and again on day 14.

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 27, 2022
• Study Start: June 1, 2023
• Primary Completion: November 22, 2025
• Study Completion: November 22, 2025
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)