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
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

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.