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

Randomised, double blind, placebo controlled, cross over study to investigate the effect of dietary supplementation with coenzyme Q10 on endothelial function in males with the metabolic syndrome who are concurrently on statin treatment.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000232235

Enrollment

Registered

2009-05-08

Start date

2008-10-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Coenzyme Q10 supplementation is increasingly used for the prevention of heart disease. Supplementation with coenzyme Q10 has been shown to improve cardiovascular function in people with type 2 diabetes. Improving cardiovascular function can reduce the risk of heart disease. In a previous study we found that reductions in coenzyme Q10 levels due to statin therapy were associated with improvements in cardiovascular function. We hypothesised that coenzyme Q10 supplementation may enhance the beneficial effect of statin treatment and further contribute to reducing the risk of heart disease. The study aims to investigate whether supplementation with coenzyme Q10 can further improve cardiovascular function in patients taking statin medication and thereby give additional benefit to statin treatment in protection from heart disease.

Interventions

Coenzyme Q10 dietary supplement is a tablet (100mg) to be taken orally, twice daily for 3 months. There is a 1 month washout period between intervention and control or vice versa depending on treatment allocation.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

Male

Age

35 Years to 65 Years

Healthy volunteers

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

Outcome results