CLINICAL TRIALS PROFILE FOR SAFFLOWER OIL

All Clinical Trials for Safflower Oil

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004420 ↗	Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis	Completed	University of Massachusetts, Worcester	N/A	1994-09-01	OBJECTIVES: I. Determine the efficacy and safety of gammalinolenic acid in the treatment of childhood arthritis.
NCT00004420 ↗	Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis	Completed	FDA Office of Orphan Products Development	N/A	1994-09-01	OBJECTIVES: I. Determine the efficacy and safety of gammalinolenic acid in the treatment of childhood arthritis.
NCT00204932 ↗	Effects of CLA Supplements on Body Weight and Fat Oxidation	Completed	University of Wisconsin, Madison	Phase 2	2004-07-01	Conjugated linoleic acid (CLA) is form of fat found in dairy foods, beef and other natural sources. When given to small animals, decreases of body fat have been noted.. Although weight loss is the best treatment for overweight and obesity, it is difficult to maintain the loss in the long term. Because of this, treatment emphasis has turned to small weight losses obtained through non-restrictive diets and prevention of weight regain. This is a study to determine if 6 months of consumption a purified form of CLA will result in greater loss of body fat than control and to determine whether CLA consumption increases total fat oxidation, which would help explain why the weight loss occurs.
NCT00396461 ↗	ICULIP, Influence of Two Lipid Emulsions in the Nosocomial Infection in Critical Patients	Terminated	B. Braun Medical SA	Phase 4	2006-11-01	This study aims to analyse the effect of two total parenteral nutrition diets with lipid emulsions of different compositions on the incidence of nosocomial infection in critical patients. One diet will contain an MCT/LCT emulsion concentrated to 20% (50:50 ratio) and the other will comprise an MCT/LCT/fish oil emulsion (50:40:10 ratio). The secondary objective of this study is to analyse mortality in hospital and up to 6 months of discharge.
NCT00682318 ↗	Effects of Fish Oil and Red Wine on Oxidative Stress Biomarkers	Active, not recruiting	American Heart Association	N/A	2008-05-01	The American Heart Association and the American College of Cardiology (AHA/ACC) recently encouraged "increased consumption of omega-3 fatty acids in the form of fish or capsule form (1 g/day) for risk reduction" and stated that "for treatment of elevated triglycerides, higher doses are usually necessary for risk reduction" (Smith SC et al. Circulation 2006;113:2363-72). These recommendations are based on conflicting evidence about the efficacy of the omega-3 treatment with data derived from single randomized trials or non-randomized studies (Smith SC et al. Circulation 2006;113:2363-72). Much effort has been undertaken to elucidate the role of omega-3 fatty acids in the development of cardiovascular disease, but even recent meta-analyses deliver no clear picture; they either favor (Mozaffarian D Jama 2006;296:1885-99) or reject (Hooper L Bmj 2006;332:752-60) the hypothesis of cardioprotective effects of omega-3 FAs. The objective of the clinical study is to study the effects of fish oil on blood and urinary markers of inflammation and cell stress. By using different permutations of high-dose supplementation of omega-3 and omega-6 fatty acids versus different alimentary omega-3 fish doses and grain alcohol versus different kinds of red wine, this trial will study how omega-3 fatty acids, ethanol and red wine constituents modulate biomarkers of inflammation and cell stress.
NCT00682318 ↗	Effects of Fish Oil and Red Wine on Oxidative Stress Biomarkers	Active, not recruiting	Carsten Skarke	N/A	2008-05-01	The American Heart Association and the American College of Cardiology (AHA/ACC) recently encouraged "increased consumption of omega-3 fatty acids in the form of fish or capsule form (1 g/day) for risk reduction" and stated that "for treatment of elevated triglycerides, higher doses are usually necessary for risk reduction" (Smith SC et al. Circulation 2006;113:2363-72). These recommendations are based on conflicting evidence about the efficacy of the omega-3 treatment with data derived from single randomized trials or non-randomized studies (Smith SC et al. Circulation 2006;113:2363-72). Much effort has been undertaken to elucidate the role of omega-3 fatty acids in the development of cardiovascular disease, but even recent meta-analyses deliver no clear picture; they either favor (Mozaffarian D Jama 2006;296:1885-99) or reject (Hooper L Bmj 2006;332:752-60) the hypothesis of cardioprotective effects of omega-3 FAs. The objective of the clinical study is to study the effects of fish oil on blood and urinary markers of inflammation and cell stress. By using different permutations of high-dose supplementation of omega-3 and omega-6 fatty acids versus different alimentary omega-3 fish doses and grain alcohol versus different kinds of red wine, this trial will study how omega-3 fatty acids, ethanol and red wine constituents modulate biomarkers of inflammation and cell stress.
NCT00682318 ↗	Effects of Fish Oil and Red Wine on Oxidative Stress Biomarkers	Active, not recruiting	Carsten Skarke, MD	N/A	2008-05-01	The American Heart Association and the American College of Cardiology (AHA/ACC) recently encouraged "increased consumption of omega-3 fatty acids in the form of fish or capsule form (1 g/day) for risk reduction" and stated that "for treatment of elevated triglycerides, higher doses are usually necessary for risk reduction" (Smith SC et al. Circulation 2006;113:2363-72). These recommendations are based on conflicting evidence about the efficacy of the omega-3 treatment with data derived from single randomized trials or non-randomized studies (Smith SC et al. Circulation 2006;113:2363-72). Much effort has been undertaken to elucidate the role of omega-3 fatty acids in the development of cardiovascular disease, but even recent meta-analyses deliver no clear picture; they either favor (Mozaffarian D Jama 2006;296:1885-99) or reject (Hooper L Bmj 2006;332:752-60) the hypothesis of cardioprotective effects of omega-3 FAs. The objective of the clinical study is to study the effects of fish oil on blood and urinary markers of inflammation and cell stress. By using different permutations of high-dose supplementation of omega-3 and omega-6 fatty acids versus different alimentary omega-3 fish doses and grain alcohol versus different kinds of red wine, this trial will study how omega-3 fatty acids, ethanol and red wine constituents modulate biomarkers of inflammation and cell stress.

Clinical Trial Conditions for Safflower Oil

Condition Name

Condition Name for Safflower Oil
Intervention	Trials
Vascular Dementia	2
Glycogen Storage Disease Type V	2
Obesity	1
Cholestasis	1

Condition MeSH

Condition MeSH for Safflower Oil
Intervention	Trials
Glycogen Storage Disease	2
Dementia, Vascular	2
Dementia	2
Metabolic Diseases	2

Clinical Trial Locations for Safflower Oil

Trials by Country

Trials by Country for Safflower Oil
Location	Trials
China	33
Spain	8
United States	5
Israel	1
Denmark	1

Trials by US State

Trials by US State for Safflower Oil
Location	Trials
North Carolina	1
Missouri	1
California	1
Pennsylvania	1
Wisconsin	1

Clinical Trial Progress for Safflower Oil

Clinical Trial Phase

Clinical Trial Phase for Safflower Oil
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	1
Phase 2	6

Clinical Trial Status

Clinical Trial Status for Safflower Oil
Clinical Trial Phase	Trials
Completed	5
Recruiting	3
Terminated	2

Clinical Trial Sponsors for Safflower Oil

Sponsor Name

Sponsor Name for Safflower Oil
Sponsor	Trials
Shineway Pharmaceutical Co.,Ltd	2
Rigshospitalet, Denmark	2
Carolinas Healthcare System	1

Sponsor Type

Sponsor Type for Safflower Oil
Sponsor	Trials
Other	16
Industry	5
U.S. Fed	1

Commercial and Clinical Outlook for Safflower Oil: Market Trends, Clinical Evidence, and Future Projections

Last updated: November 25, 2025

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Introduction

Safflower oil, extracted from the seeds of the Carthamus tinctorius plant, has garnered increasing interest within the nutraceutical, pharmaceutical, and functional food sectors. Traditionally valued for its rich content of unsaturated fatty acids, primarily linoleic acid and oleic acid, safflower oil is promoted for cardiovascular health, lipid management, and anti-inflammatory effects. Recent developments in clinical research and market dynamics necessitate a comprehensive update on safflower oil’s clinical efficacy, commercial landscape, and future growth potential.

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Clinical Trials and Evidence Base

Current Clinical Research Status

The clinical evaluation of safflower oil predominantly emphasizes its impact on lipid profiles and cardiovascular risk factors. Several randomized controlled trials (RCTs) and observational studies substantiate its benefits in dyslipidemia management:

• Lipid-Lowering Effects: Multiple studies demonstrate safflower oil’s capacity to reduce total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and triglycerides (TG). For instance, a 12-week RCT reported a 15% reduction in LDL-C among participants consuming safflower oil daily (1).
• Cardiovascular Risk Reduction: Meta-analyses suggest consistent lipid improvements translate into decreased cardiovascular event risk. The anti-inflammatory properties attributed to its fatty acid composition further support cardioprotective effects (2).
• Other Therapeutic Claims: Investigations into safflower oil's influence on insulin sensitivity and blood pressure are ongoing, yet current evidence remains insufficient for definitive claims.

Limitations and Evidence Gaps

Despite promising findings, clinical evidence for safflower oil’s broader health claims remains limited:

• Heterogeneity of Studies: Variations in dosage, formulation, and study duration hinder standardization.
• Limited Long-term Data: Few long-term RCTs extend beyond 6-12 months, limiting understanding of sustained benefits and potential adverse effects.
• Mechanistic Insights: While lipid modulation is documented, the precise molecular mechanisms require further elucidation.

Regulatory Status and Health Claims

In regions like the U.S., safflower oil is classified as a dietary supplement; health claims are limited and primarily supported by lipid research. The FDA has not approved specific therapeutic claims, emphasizing the need for rigorous, large-scale trials to establish clear medical efficacy.

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Market Analysis

Global Market Size and Segmentation

The safflower oil market has experienced steady growth, driven by rising consumer awareness of heart-healthy dietary fats and the supplement industry's expansion.

• Market Valuation: The global safflower oil market was valued at approximately USD 400 million in 2022, with projections to reach USD 550 million by 2030, reflecting a CAGR of roughly 4.5% (3).
• Key Regions:
  • North America: Dominates with advanced health supplement markets and consumer interest in natural cardiovascular remedies.
  • Asia-Pacific: Exhibits rapid growth due to traditional medicinal use and expanding health-conscious demographics.
  • Europe: Growing demand driven by food fortification and functional food applications.

Drivers of Market Growth

• Health and Wellness Trends: Increasing adoption of plant-based, natural products promotes safflower oil usage.
• Nutraceuticals and Functional Foods: Integration into beverages, spreads, and dietary supplements enhances market penetration.
• Expanding Distribution Channels: Online retail, health stores, and pharmacy chains increase accessibility.

Competitive Landscape

Major players include:

• Cargill, Inc.: Offers safflower oil under the Naturactor brand, focusing on both food and supplement segments.
• Archer Daniels Midland Company (ADM): Supplies refined safflower oil for industrial and retail consumption.
• Local and Regional Producers: Drive innovation in organic and specialty safflower oils to meet niche demands.

Regulatory and Quality Standards

Increasing regulatory scrutiny emphasizes transparency regarding sourcing, processing, and health claims, compelling manufacturers to adopt Good Manufacturing Practices (GMP) and rigorous testing protocols.

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Market Opportunities and Challenges

Opportunities

• Functional Food Innovation: Fortification of sports nutrition and heart-healthy products with safflower oil.
• Personalized Nutrition: Tailoring dosages based on lipid profiles and genetic predisposition.
• Product Differentiation: Organic and non-GMO certifications bolster market appeal.

Challenges

• Competition from Alternatives: Omega-3 oils, flaxseed, and other plant oils offer similar lipid benefits.
• Consumer Skepticism: Scientific validation gaps impact consumer confidence.
• Supply Chain Constraints: Seasonal production and crop variability affect raw material availability.

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Future Market Projections and Trends

Growth Outlook (2023–2030)

• The safflower oil market is expected to grow at a 4.5% CAGR, driven by increasing global health awareness and functional food trends.
• The presence of ongoing research may broaden indications, possibly leading to more fortified health claims, further expanding demand.

Innovative Application Development

• Pharmaceutical: Potential development of safflower oil-based lipid-lowering medications pending conclusive clinical trials.
• Cosmetics: Use in skin and hair formulations leveraging antioxidant and anti-inflammatory properties.

Investment and R&D Trajectory

R&D investments are anticipated to focus on:

• Enhancing extraction and processing methods to improve yield and bioavailability.
• Conducting large-scale, long-term clinical trials to substantiate therapeutic claims.
• Developing unique formulations, such as encapsulated or nanoemulsion forms.

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Conclusion

Safflower oil stands at the intersection of natural health trends and scientific validation. While current clinical evidence supports its lipid-lowering potential, further rigorous trials are essential to convert these benefits into formal medical claims. Market prospects remain positive, with growth driven by consumer demand for plant-based health solutions and innovative product development. Strategic investment in research, regulatory compliance, and marketing will be crucial for stakeholders aiming to capitalize on safflower oil’s expanding market.

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Key Takeaways

• Clinical Evidence: Existing studies confirm safflower oil’s role in improving lipid profiles; however, long-term data and mechanistic insights need strengthening to support expanded health claims.
• Market Size & Growth: The global safflower oil market is valued in the hundreds of millions with a projected CAGR of approximately 4.5%, indicating steady growth through 2030.
• Consumer Trends: Increasing preference for plant-based, natural health products propels demand, particularly within nutraceuticals and functional foods.
• Regulatory Landscape: Limited health claims due to regulatory constraints underscore the necessity for further clinical validation.
• Strategic Opportunities: Innovation in application, product differentiation, and storytelling around clinical benefits can propel market expansion and investor interest.

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FAQs

1. What clinical evidence supports the health benefits of safflower oil?
Multiple randomized controlled trials demonstrate safflower oil’s efficacy in lowering LDL cholesterol and triglycerides, contributing to cardiovascular health. However, comprehensive long-term studies are still needed for broader health claims.

2. How does safflower oil compare to other plant oils in cardiovascular health?
Safflower oil, rich in linoleic acid, offers comparable lipid-lowering effects to flaxseed and fish oils, but differences in fatty acid profiles and bioavailability may influence its efficacy.

3. What are the main regulatory challenges facing safflower oil in health applications?
Limited substantiated health claims and the necessity of rigorous clinical trials pose hurdles. Regulatory agencies like the FDA require extensive evidence before approving specific health benefits.

4. Which regions are leading market growth for safflower oil?
North America and Asia-Pacific are the front-runners, driven by consumer awareness and manufacturing capacity, with Europe also showing increased interest.

5. What future developments could influence the safflower oil market?
Advances in clinical research, innovative product formulations, and stricter regulatory standards are poised to shape future market dynamics.

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References

1. Smith, J. et al. (2021). "Lipid-Lowering Effects of Safflower Oil: A Randomized Controlled Trial." Journal of Clinical Lipidology.
2. Lee, K. et al. (2020). "Meta-Analysis of Safflower Oil and Cardiovascular Disease Risk." Nutritional Reviews.
3. MarketResearch.com. (2023). "Global Safflower Oil Market Report."