Effects of CoQ10 on Inflammatory Response in Cardiac Surgery

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Drug: Coenzyme Q10; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coenzyme Q10 group; Participants in the experimental group will be given 10mg of Coenzyme Q10 each time (3 times a day).	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.; Other Names: ubiquinone
Sham Comparator: Control; Participants in the experimental group will be given 10mg of placebo each time (3 times a day).	Dietary supplement: Placebo; placebo that looks and tastes identical to Coenzyme Q10

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C-reactive protein	Inflammatory and endothelial blood work biomarkers	Change from baseline of CRP in mg/L at 5 days after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interleukin-6	Inflammatory and endothelial blood work biomarkers	Change from baseline of IL-6 in pg/mL at 5 days after surgery.

Collaborators and Investigators

• Sponsor: Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: June 20, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 23, 2020

Study Record Updates

• Last Update Posted (Actual): June 23, 2020
• Last Update Submitted That Met QC Criteria: June 22, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Physiological Effects of Drugs; Micronutrients; Vitamins; Coenzyme Q10; Ubiquinone
• Other Study ID Numbers: CoQ10-Jph 2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No