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NCT04444349 Clinical Trial

Effects of CoQ10 on Inflammatory Response in Cardiac Surgery

Cardiovascular Disease Clinical Trial

Official title:
The Effects of the Dietary Supplement Coenzyme Q10 on Inflammatory Responses in Individuals With Cardiac Surgery: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04444349
Other study ID # CoQ10-Jph 2020
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2020
Est. completion date December 31, 2022

Study information
Verified date June 2020
Source Nanjing Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Cardiovascular diseases are the leading causes of death and prescription drug use. Research on certain dietary supplements looks promising as a way to help reduce risk factors. Previous studies showed that CoQ10 levels were decreased in cardiovascular patients and worsening of mitochondrial dysfunction was observed. The overall objective of this study is to determine if supplementing with CoQ10 can reduce inflammatory risk factors in adults with cardiac surgery, independent of other dietary or physical activity changes.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 300
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Adult men and women

- Elective cardiac surgery

- Cardiac surgery on cardiopulmonary bypass

Exclusion Criteria:

- Pregnant or planning on getting pregnant during the study

- Emergency cardiac surgery

- Contain a minimum of 2 traits of metabolic syndrome

- Cardiac surgery without cardiopulmonary bypass

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Coenzyme Q10
Coenzyme Q10 is a cardiovascular health supplement. It is a component of the electron transport chain and participates in aerobic cellular respiration, which generates energy in the form of ATP. The ingredients in Coenzyme Q10 help regulate the body's production of free radicals, strengthen the arteries and heart, and reverse oxidation.
Dietary Supplement:
• Placebo
placebo that looks and tastes identical to Coenzyme Q10

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Nanjing Medical University

Outcome
Type Measure Description Time frame Safety issue
Primary C-reactive protein Inflammatory and endothelial blood work biomarkers Change from baseline of CRP in mg/L at 5 days after surgery.
Secondary Interleukin-6 Inflammatory and endothelial blood work biomarkers Change from baseline of IL-6 in pg/mL at 5 days after surgery.
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