NCT03961763

Effect of n-3 Fatty Acid Supplementation in Hyperlipidemic Patients Taking Statins

Completed NA Last updated 23 May 2019

What this trial tests

NA trial testing EPA+DHA in Cardiovascular Diseases in 44 participants. Completed in 1 November 2018.

Timeline

1 June 2017

Primary endpoint
1 November 2017

1 November 2018

Quick facts

Lead sponsor	University of Chester
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	44
Start date	1 June 2017
Primary completion	1 November 2017
Estimated completion	1 November 2018
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• EPA+DHA
• Placebo

Conditions studied

• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
• Hyperlipidemias — all drugs for Hyperlipidemias →
• Dyslipidemias — all drugs for Dyslipidemias →

Sponsor

University of Chester

Who can join

Adults 50 to 70, any sex, with Cardiovascular Diseases or Hyperlipidemias. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Epidemiological and clinical evidence suggests that high-dose intake of long-chain n-3 fatty acids have a favorable role in altering blood TG and non-HDL cholesterol when combined with statins in hyperlipidemic patients. Their efficacy in altering low density lipoprotein cholesterol particle size and concentration is yet to be confirmed.

This study evaluates the effects of adding 4/day eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) to stable statin therapy on blood TG, non-HDL, LDL-C as well as small dense (sdLDL) particle concentration in a group of hyperlipidemic patients.

In this randomized, placebo-controlled, double-blind parallel group study, 44 subjects who were already on statin therapy for \> 8 weeks and had non-HDL-C levels above the National Lipid Association Recommendations were randomized into two groups. For 8 weeks, together with their prescribed atorvastatin, the intervention group received 4g/day EPA+DHA (in ethyl ester form) while the control group received 4g/day olive oil (placebo). Baseline measurements of non-HDL-C, TG, TC, HDL-C, LDL-C, VLDL-C and sdLDL were repeated at week 8. Differences in dietary intake were assessed with a weighed 3-day food diary at week 4. Primary outcome measures are the percent change in non-HDL-C and sdLDL particle concentration from baseline to the end.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. N-3 fatty acid supplementation mediates lipid profile, including small dense LDL, when combined with statins: a randomized double blind placebo controlled trial.
   Dogay Us G, Mushtaq S. · · 2022 · cited 5× · PMID 36050695 · DOI 10.1186/s12944-022-01686-y