Hypertriglyceridemia Clinical Trial
Official title:
Effect of Fish Oil as an Ethyl Ester or Triglyceride Preparation on Plasma Triglycerides in Hypertriglyceridemic Adults
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03929198 -
Translation of Pritikin Program to the Community
|
N/A | |
Completed |
NCT02250105 -
Trial of ARI-3037MO to Reduce Triglyceride Levels in Adults With Severe (≥500 mg/dl) Hypertriglyceridemia
|
Phase 2 | |
Completed |
NCT02859129 -
Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®)
|
Phase 1 | |
Completed |
NCT01455844 -
TRIal For Efficacy of Capre on hyperTriglyceridemiA
|
Phase 2 | |
Completed |
NCT01437930 -
Intervention With n-3 Polyunsaturated Fatty Acids (PUFA)-Supplemented Products in Moderate Hypertriglyceridemic Patients
|
N/A | |
Completed |
NCT01010399 -
Boosted Lexiva With Lovaza Adjunctive Therapy in Hypertriglyceridemic, HIV-Infected Subjects
|
Phase 4 | |
Completed |
NCT00959842 -
Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia
|
Phase 1/Phase 2 | |
Completed |
NCT00519714 -
A Study to Evaluate the Lipid Regulating Effects of 1-Methylnicotinamide (1-MNA)
|
Phase 2/Phase 3 | |
Recruiting |
NCT00186537 -
Comparing Tricor, Avandia, or Weight Loss to Lower Cardiovascular Risk Factors in People With High Triglycerides.
|
N/A | |
Completed |
NCT00246402 -
Acipimox to Improve Hyperlipidemia and Insulin Sensitivity Associated With HIV
|
N/A | |
Completed |
NCT06020950 -
Chia Seeds Consumption in Hypertriglyceridemia
|
N/A | |
Completed |
NCT02354976 -
A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects.
|
Phase 2 | |
Completed |
NCT04966494 -
Impact of Beans and Oats Snack Bar on Hypertriglyceridemic Women
|
N/A | |
Completed |
NCT04650152 -
Study to Assess Tricor Therapy Effectiveness in Patients With Metabolic Syndrome (TRISTAN)
|
||
Completed |
NCT04630366 -
A Phase 1, First Time in Humans Study of NST-1024
|
Phase 1 | |
Completed |
NCT03693131 -
Efficacy of MND-2119 in Participants With Hypertriglyceridemia
|
Phase 3 | |
Completed |
NCT04756180 -
An Efficacy and Safety Study of Omega-3-acid Ethyl Ester in Chinese Subjects With Hypertriglyceridemia.
|
Phase 3 | |
Completed |
NCT02868177 -
Effect of Totum-63, Active Ingredient of Valedia, on Glucose and Lipid Homeostasis on Subjects With Prediabetes
|
Phase 2/Phase 3 | |
Completed |
NCT01968720 -
Pilot Study To Assess CAT-2003 in Patients With Severe Hypertriglyceridemia
|
Phase 2 | |
Completed |
NCT01462877 -
A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic
|
Phase 4 |