Study to Investigate the Effects of Coenzyme Q10 Supplementation on Cardiovascular Health in Males Receiving Statin Medication for High Cholesterol Levels

Recruiting

• Conditions: Dyslipidemia; Metabolic and Endocrine - Metabolic disorders; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12609000232235
• Lead Sponsor: ipid and Diabetes Research Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

Waist circumference >= 94cm
Triglycerides >=1.7 mmol/L or specific therapy for tirglycerides
Systolic blood presure >=130 mmHg or Diastolic blood pressure >=85 mmHg or treatment for hypertension
Statin naive or treatment with <=40mg/day simvastatin or equivalent

Exclusion Criteria

Pre-treatment Low-density Lipoprotein (LDL)-cholesterol <1.5mmol/L or >6.5 mmol/L
Pre-treatment triglycerides >5 mmol/L
History of cardiovascular event or intervention within the 6 months prior to screening
Type 1 diabetes mellitus
Type 2 diabetes mellitus requiring oral anti-diabetic agents or insulin
Current smoker
Treatment with fibrates or other lipid modifying agents other than statin therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Flow-mediated dilation of the brachial artery (endothelium dependent function) to be assessed with ultrasound.[At baseline and at 3 months after intervention commencement]

Secondary Outcome Measures

Name	Time	Method
Endothelial independent dilation of the brachial artery to be assessed with ultrasound.[At baseline and at 3 months after intervention commencement];Augmentation index using a medical device with a pressure sensor to measure the siffness of the blood vessels.[At baseline and at 3 months after intervention commencement];Systolic and diastolic blood pressure assessed with an automated blood pressure monitor.[At baseline and at 3 months after intervention commencement];Markers of cardiovascular risk measured from blood tests.[At baseline and at 3 months after intervention commencement];Coenzyme Q10 levels measured from a blood test.[At baseline and at 3 months after intervention commencement];Quality of Life Scores assessed using a Quality of Life Questionnaire.[At baseline and at 3 months after intervention commencement]