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Effects of CoQ10 on Inflammatory Response in Cardiac Surgery

Sponsor
Nanjing Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04444349
Collaborator
(none)
300
Enrollment
2
Arms
29
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Coenzyme Q10
  • Dietary Supplement: Placebo
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
The Effects of the Dietary Supplement Coenzyme Q10 on Inflammatory Responses in Individuals With Cardiac Surgery: A Randomized Controlled Trial
Anticipated Study Start Date :
Aug 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. C-reactive protein [Change from baseline of CRP in mg/L at 5 days after surgery.]

      Inflammatory and endothelial blood work biomarkers

    Secondary Outcome Measures

    1. Interleukin-6 [Change from baseline of IL-6 in pg/mL at 5 days after surgery.]

      Inflammatory and endothelial blood work biomarkers

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Nanjing Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hong Liu, Investigator of Cardio-Thoracic Surgery, Nanjing Medical University
    ClinicalTrials.gov Identifier:
    NCT04444349
    Other Study ID Numbers:
    • CoQ10-Jph 2020
    First Posted:
    Jun 23, 2020
    Last Update Posted:
    Jun 23, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cardiovascular Diseases
    Ubiquinone
    Coenzyme Q10

    Study Results

    No Results Posted as of Jun 23, 2020