Effect of Fish Oil on Plasma Triglycerides in Adults

NCT00804427 | Completed

• 1 other identifier: SU-12042008-1358
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this small, short pilot study is to determine the feasibility (e.g., recruitment, dose acceptance, retention) of a future longer trial comparing the effects of two types of omega-3 fats from fish oil on plasma triglycerides. The two types of fish oil are composed of (1) omega-3 fatty acids in triglyceride form; and (2) as esterified free fatty acids (i.e. ethyl esters). Although these two types of fish oil supplements are available to the public, it remains unclear whether they are equally effective in lowering plasma triglycerides.

Conditions

Hypertriglyceridemia

Keywords

Fish oil; Triglycerides; Low-density Lipoprotein (LDL) cholesterol; Low-density Lipoprotein (LDL) subclass; Low-density Lipoprotein (LDL) particle size; Low-density Lipoprotein (LDL) phenotype

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Triglycerides at 3 months

  Change was calculated as the value at 3 months minus the value at baseline

  Baseline and 3 months

Secondary Outcomes (2)

• Change from baseline in LDL particle concentration (LDL1, LDL2, LDL3, LDL4) at 3 months

  Baseline and 3 months

• Change from baseline in LDL phenotype pattern (A, B, or A/B) at 3 months

  Baseline and 3 months

Study Arms (4)

Fish oil (90% triglycerides)

EXPERIMENTAL

Fish oil (4 grams/day of combined EPA and DHA) as 90% triglyceride formulation, taken in two divided doses with main meals.

Dietary Supplement: Fish oil (90% triglycerides)

Fish oil (60% triglycerides)

EXPERIMENTAL

Fish oil (4 grams/day of combined EPA and DHA) as 60% triglyceride formulation, taken in two divided doses with main meals.

Dietary Supplement: Fish oil (60% triglycerides)

Fish oil (ethyl esters)

EXPERIMENTAL

Fish oil (4 grams/day of combined EPA and DHA) as ethyl esters formulation (0% triglycerides), taken in two divided doses with main meals.

Dietary Supplement: Fish oil (ethyl esters)

Soy oil

PLACEBO COMPARATOR

Soy oil supplement with identical total fat content, taken in two divided doses with main meals.

Dietary Supplement: Soy oil

Interventions

Fish oil (90% triglycerides) DIETARY_SUPPLEMENT

Fish oil (90% triglycerides)

Fish oil (60% triglycerides) DIETARY_SUPPLEMENT

Fish oil (60% triglycerides)

Fish oil (ethyl esters) DIETARY_SUPPLEMENT

Fish oil (ethyl esters)

Soy oil DIETARY_SUPPLEMENT

Soy oil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: \> or = 18 years
• Ethnicity and race: All ethnic and racial backgrounds welcome
• Fasting blood triglycerides greater than or equal to 150 mg/dL
• Planning to be available for clinic visits for the 12 weeks of study participation
• Ability and willingness to give written informed consent

You may not qualify if:

• Daily intake of dietary supplements containing omega-3 FAs within the past month.
• Fasting blood glucose greater than or equal to 126 mg/dL
• Self reported personal history of:
• Clinically significant atherosclerosis (e.g., CAD, PAD)
• Malignant neoplasm
• Subjects currently receiving the following medications (self report):
• Lipid lowering drugs including statins
• Anti-hypertensive drugs: beta-blockers and thiazides
• Body Mass Index (BMI) greater than or equal to 40.
• Pregnant or Lactating
• Inability to communicate effectively with study personnel

Sponsors & Collaborators

• Stanford University: lead
• Nordic Naturals: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• Oelrich B, Dewell A, Gardner CD. Effect of fish oil supplementation on serum triglycerides, LDL cholesterol and LDL subfractions in hypertriglyceridemic adults. Nutr Metab Cardiovasc Dis. 2013 Apr;23(4):350-7. doi: 10.1016/j.numecd.2011.06.003. Epub 2011 Sep 15.

  PMID: 21924882 RESULT

Related Links

• Description of study and summary of results

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

Fish Oils; Triglycerides; Soybean Oil

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Oils; Lipids; Glycerides; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fats, Unsaturated; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Christopher D Gardner

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine (Research)

Study Record Dates

• First Submitted: December 4, 2008
• First Posted: December 8, 2008
• Study Start: December 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: April 1, 2010
• Last Updated: February 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)