Hypertriglyceridemia
Conditions
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
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.
Detailed description
This study is a double-blinded, parallel design, placebo controlled trial with three active treatment arms to compare the triglyceride (TG) lowering effects of the same dose of EPA and DHA provided in three formulations of supplements that differ in the proportion of omega-3 FA present as ethyl esters vs. triglycerides. The active therapy for each of the three fish oil supplementation arms is 4 g/day of combined EPA and DHA provided as: a) 90% TG formulation, b) 60% TG formulation, or c) ethyl esters (esterified fatty acids)(i.e., 0% TG). The placebo was a soy oil supplement with an identical total fat content. The primary outcome is the 12-week change in TG concentrations in the active groups vs. placebo. Secondary outcomes include LDL particle distribution, defined as either subclasses LDL1, LDL2, LDL3 and LDL4, and LDL subclass phenotype patterns A, B, or A/B.
Interventions
DIETARY_SUPPLEMENTFish oil (90% triglycerides)
DIETARY_SUPPLEMENTFish oil (60% triglycerides)
DIETARY_SUPPLEMENTFish oil (ethyl esters)
DIETARY_SUPPLEMENTSoy oil
Sponsors
Nordic Naturals
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
\*Gender: Both women and men * 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 * No known active psychiatric illness.
Exclusion criteria
\*At screening: * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Triglycerides at 3 months | Baseline and 3 months | Change was calculated as the value at 3 months minus the value at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in LDL particle concentration (LDL1, LDL2, LDL3, LDL4) at 3 months | Baseline and 3 months | Change was calculated as the value at 3 months minus the value at baseline |
| Change from baseline in LDL phenotype pattern (A, B, or A/B) at 3 months | Baseline and 3 months | Change was calculated as the number (and percent) of participants who improved their LDL phenotype pattern at 3 months. |
Countries
United States
Outcome results
None listed