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

NCT03961763 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2019-05-23

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

EPA+DHA

4 g/day EPA+DHA in tablets of 1g, 4 tablets daily, over 8 weeks (56 days)

OTHER

Placebo

4 g/day olive oil placebo in tablets of 1g, 4 tablets daily, over 8 weeks (56 days).

Sponsors & Collaborators

  • University of Chester

    lead OTHER

Principal Investigators

  • Sohail Mushtaq, PhD · University of Chester

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2017-11-01
Completion
2018-11-01

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03961763 on ClinicalTrials.gov