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

NCT03961763 | Completed

• 1 other identifier: 1288/17/GD/CSN
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Cardiovascular Diseases; Hyperlipidemias; Dyslipidemias

Keywords

omega-3; EPA; DHA; sdLDL; cardiovascular disease; hyperlipidemia; dyslipidemia

Outcome Measures

Primary Outcomes (2)

• small &dense LDL I

  LDL-C III particle concentration (mg/dL)

  0 and 8 weeks

• non-HDL-C

  non-HDL cholesterol (mg/dL)

  0 and 8 weeks

Secondary Outcomes (7)

• TG

  0 and 8 weeks

• TC

  0 and 8 weeks

• HDL-C

  0 and 8 weeks

• LDL-C

  0 and 8 weeks

• VLDL-C

  0 and 8 weeks

Study Arms (2)

omega-3 supplement

ACTIVE COMPARATOR

This group will receive a daily dose of 4g EPA+DHA (which is the recommended safe tolerable upper intake level of omega-3 supplements for healthy individuals) for eight weeks.

Dietary Supplement: EPA+DHA

Placebo

PLACEBO COMPARATOR

This group will receive a daily dose of 4g olive oil placebo for eight weeks.

Other: Placebo

Interventions

EPA+DHA DIETARY_SUPPLEMENT

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

Also known as: marine omega-3, fish oil

omega-3 supplement

Placebo OTHER

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

Also known as: Non-active ingredient

Placebo

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female, aged between 50 and 80
• Current combined hyperlipidemia: people whose LDL and non-HDL levels are above the National Lipid Association recommendations according to their risk groups. non-HDL is also considered given the fact most recent research states looking at both values is a better risk indicator than looking at LDL alone. (Appendix 12: National Lipid Association Treatment Guideline)
• Currently on statin prescription.

You may not qualify if:

• Current use of n-3 supplements
• Recent history of certain heart, kidney, liver, or cancer:
• Patients that have had any type of heart surgery, Patients that are diagnosed with any type of cancer and/or have had any kind of cancer therapy, Patients that have had kidney failure, Patients that have had liver failure, in the past 6 months
• Pregnant or lactating females

Sponsors & Collaborators

• University of Chester: lead

Study Sites (1)

Pax Clinic

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Dogay Us G, Mushtaq S. N-3 fatty acid supplementation mediates lipid profile, including small dense LDL, when combined with statins: a randomized double blind placebo controlled trial. Lipids Health Dis. 2022 Sep 1;21(1):84. doi: 10.1186/s12944-022-01686-y.

  PMID: 36050695 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Hyperlipidemias; Dyslipidemias

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• Sohail Mushtaq, PhD

  University of Chester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 23, 2019
• Study Start: June 1, 2017
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2018
• Last Updated: May 23, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)