CLINICAL TRIALS PROFILE FOR FISH OIL TRIGLYCERIDES

505(b)(2) Clinical Trials for fish oil triglycerides

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00169299 ↗	Herbal Alternatives for Menopause Symptoms (HALT Study)	Unknown status	National Center for Complementary and Integrative Health (NCCIH)	Phase 4	2001-06-01	Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.
OTC	NCT00169299 ↗	Herbal Alternatives for Menopause Symptoms (HALT Study)	Unknown status	National Institute on Aging (NIA)	Phase 4	2001-06-01	Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.
OTC	NCT00169299 ↗	Herbal Alternatives for Menopause Symptoms (HALT Study)	Unknown status	Group Health Cooperative	Phase 4	2001-06-01	Surveys indicate that 25 to 33% of women have moderate to severe menopausal symptoms including hot flashes, night sweats, and disturbed sleep. The treatment of choice in the medical community for these symptoms is hormone replacement therapy, which is estrogen and sometimes progestin. Many women also use over-the-counter herbal remedies. However, less is known about how well these products work, or their safety. Few have undergone the kind of rigorous testing required of prescription drugs and little is known about their long-term effectiveness in relieving symptoms. The purpose of this study is to compare several over-the-counter herbal remedies to hormone replacement therapy. Our primary aim is to look at the effects of these remedies on your self-reported menopausal symptoms. We will also be measuring their effects on other factors known to be affected by hormone replacement therapy: cholesterol, blood sugar, bone density, vaginal cell structure, and blood clotting.

All Clinical Trials for fish oil triglycerides

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	Centers for Disease Control and Prevention	Phase 3	1999-09-01	The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	National Eye Institute (NEI)	Phase 3	1999-09-01	The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3	1999-09-01	The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.

Clinical Trial Conditions for fish oil triglycerides

Condition Name

Condition Name for fish oil triglycerides
Intervention	Trials
Hypertriglyceridemia	55
Hypercholesterolemia	49
HIV Infections	32

Condition MeSH

Condition MeSH for fish oil triglycerides
Intervention	Trials
Diabetes Mellitus	87
Diabetes Mellitus, Type 2	84
Hypertriglyceridemia	72

Clinical Trial Locations for fish oil triglycerides

Trials by Country

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Trials by Country for fish oil triglycerides
Location	Trials
United States	920
Canada	121
Italy	72
United Kingdom	72
Germany	49

Trials by US State

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Trials by US State for fish oil triglycerides
Location	Trials
Texas	62
California	61
New York	47
Florida	46
Pennsylvania	43

Clinical Trial Progress for fish oil triglycerides

Clinical Trial Phase

Clinical Trial Phase for fish oil triglycerides
Clinical Trial Phase	Trials
Phase 4	198
Phase 3	139
Phase 2/Phase 3	31

Clinical Trial Status

Clinical Trial Status for fish oil triglycerides
Clinical Trial Phase	Trials
Completed	417
Unknown status	68
Recruiting	62

Clinical Trial Sponsors for fish oil triglycerides

Sponsor Name

Sponsor Name for fish oil triglycerides
Sponsor	Trials
GlaxoSmithKline	27
Sanofi	18
Merck Sharp & Dohme Corp.	17

Sponsor Type

Sponsor Type for fish oil triglycerides
Sponsor	Trials
Other	752
Industry	308
NIH	61

Fish Oil and Triglycerides: Clinical Trials, Market Analysis, and Projections

Introduction to Fish Oil and Triglycerides

Fish oil, rich in omega-3 fatty acids, has been a subject of extensive research for its potential health benefits, particularly in managing triglyceride levels and cardiovascular health. This article delves into the latest clinical trials, market analysis, and future projections for fish oil as a treatment for elevated triglycerides.

Clinical Trials: Efficacy of Fish Oil in Lowering Triglycerides

Reduction in Triglyceride Levels

Clinical trials have consistently shown that fish oil supplements can significantly lower triglyceride levels. A meta-analysis of 25 randomized trials found that each 1-g increase in fish oil dose per day lowered triglyceride levels by about 8 mg/dL, with more dramatic reductions in patients with high baseline triglyceride levels[1].

In a specific study, patients with hypertriglyceridemia who received 4 g/day of omega-3 fatty acids saw their triglyceride levels decrease from 801 mg/dL to 512 mg/dL, a 38.9% reduction[1]. Prescription-strength omega-3 products, such as icosapent ethyl, have also been shown to lower triglycerides by 25-30% in clinical trials like the REDUCE-IT trial[4].

Impact on Other Lipid Profiles

While fish oil is effective in reducing triglycerides, its impact on other lipid profiles is more nuanced. Studies have shown that fish oil can increase HDL cholesterol (HDL-C) levels, though the effect is generally minimal. However, it can also increase LDL cholesterol (LDL-C) levels, with an average increase of around 6-10 mg/dL[1].

Genetic Variants and Response to Fish Oil

Recent research has highlighted the importance of genetic makeup in determining the efficacy of fish oil supplements. A study led by Kaixiong Ye found that individuals with the AG genotype at the GJB2 gene benefited from fish oil supplementation by reducing their triglyceride levels, whereas those with the AA genotype experienced an increase in triglycerides[2].

Market Analysis: Global Fish Oil Market

Current Market Size and Growth

The global fish oil market is substantial and growing. As of 2023, the market size was valued at USD 2.37 billion and is expected to reach USD 4.24 billion by 2033, growing at a CAGR of 5.12%[5].

Regional Market Dominance

The Asia-Pacific region dominates the global fish oil market, driven by aquaculture and the use of fish oil as aquafeed in countries like China, Japan, and India. Europe is the leading producer and consumer of fish oil, with a significant market share, followed by North America, where the U.S. and Canada are major players[5].

Consumer Demand and Drivers

The demand for fish oil supplements is driven by growing awareness of the health benefits of omega-3 fatty acids, including improved cardiovascular health and reduced inflammation. Consumers are increasingly seeking natural ways to support overall well-being and prevent chronic diseases, which is fueling the growth of the fish oil market[5].

Clinical Considerations and Future Directions

Combination Therapy with Statins

For patients with mixed dyslipidemias, combining fish oil with statin therapy may offer advantages. While statins effectively lower LDL-C, they have modest effects on triglycerides. Fish oil, on the other hand, effectively reduces triglycerides but can increase LDL-C levels. The combination may help achieve stricter triglyceride and LDL-C targets set by current guidelines[1].

Personalized Nutrition Based on Genotype

The discovery of genetic variants that influence the response to fish oil supplementation opens up possibilities for personalized nutrition. Future research aims to optimize fish oil supplementation recommendations based on an individual's unique genetic composition, which could lead to significant improvements in health and well-being[2].

Cardiovascular Benefits and Risks

Protection Against Cardiovascular Disease

Clinical trial data support the hypothesis that long-chain omega-3s offer protection against cardiovascular disease by reducing the heart’s susceptibility to arrhythmias, lowering triglyceride levels, lowering blood pressure, and decreasing platelet aggregation. Studies like the GISSI-Prevenzione trial and the Japan EPA Lipid Intervention Study have shown that omega-3s reduce rates of all-cause mortality, cardiac death, sudden death, and stroke, particularly in secondary prevention[3].

Risks and Limitations

While fish oil has several benefits, it is not without risks. The increase in LDL-C levels, although potentially less atherogenic due to larger LDL particle size, remains a concern. Additionally, not all clinical trials have shown cardiovascular benefits, highlighting the need for more targeted and genetically informed approaches to supplementation[1][4].

Key Takeaways

• Efficacy in Reducing Triglycerides: Fish oil supplements are effective in lowering triglyceride levels, with significant reductions observed in clinical trials.
• Genetic Influence: The response to fish oil supplementation can vary based on genetic makeup, with certain genotypes benefiting more than others.
• Market Growth: The global fish oil market is growing, driven by increasing awareness of the health benefits of omega-3 fatty acids.
• Clinical Considerations: Combination therapy with statins and personalized nutrition based on genotype are potential future directions.
• Cardiovascular Benefits: Fish oil has been shown to offer protection against cardiovascular disease, although the benefits can vary depending on the population and study design.

FAQs

Q: How effective is fish oil in reducing triglyceride levels?

Fish oil is highly effective in reducing triglyceride levels, with studies showing reductions of up to 38.9% in patients with hypertriglyceridemia[1].

Q: Does fish oil increase LDL cholesterol levels?

Yes, fish oil supplementation can increase LDL cholesterol levels, although the increase is generally modest and the larger LDL particles produced may be less atherogenic[1].

Q: Can genetic makeup affect the response to fish oil supplements?

Yes, recent research indicates that genetic variants, such as those at the GJB2 gene, can influence whether an individual benefits from or experiences adverse effects from fish oil supplementation[2].

Q: What are the cardiovascular benefits of fish oil?

Fish oil has been shown to reduce the risk of cardiovascular disease by lowering triglyceride levels, reducing arrhythmias, lowering blood pressure, and decreasing platelet aggregation[3].

Q: Is the global fish oil market growing?

Yes, the global fish oil market is expected to grow from USD 3.16 billion in 2024 to USD 4.24 billion by 2033, driven by increasing consumer awareness of the health benefits of omega-3 fatty acids[5].

Sources

1. What can we expect from omega-3 fatty acids? - CCJM.
2. Fish oil benefits some, may increase triglycerides in others - UGA News.
3. Omega-3 Fatty Acids - Health Professional Fact Sheet - NIH.
4. Hypertriglyceridemia Trials: Insights on Managing Triglycerides - Fomat Medical.
5. Fish Oil Market Size to Expand at US$4.24 billion by 2033 - Straits Research.