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
Mild to Moderate Psoriasis	1
NASH	1

Condition MeSH

Condition MeSH for Safflower Oil
Intervention	Trials
Dementia	2
Metabolic Diseases	2
Cholestasis	2
Glycogen Storage Disease Type V	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
Unknown status	2

Clinical Trial Sponsors for Safflower Oil

Sponsor Name

Sponsor Name for Safflower Oil
Sponsor	Trials
Rigshospitalet, Denmark	2
Shineway Pharmaceutical Co.,Ltd	2
American Heart Association	1

Sponsor Type

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

Safflower Oil: Clinical Trials Update, Market Analysis, and Future Outlook

Last updated: February 24, 2026

What Is the Current Status of Clinical Trials for Safflower Oil?

Research into safflower oil's health benefits continues primarily around cardiovascular health, lipid management, and anti-inflammatory effects. Several studies are ongoing or completed, with mixed results.

• Over 20 clinical trials registered on ClinicalTrials.gov examine safflower oil's effects.
• Most trials involve dosages between 1 to 4 grams daily.
• Completed trials show improvements in lipid profiles, particularly LDL cholesterol reduction.
• Notably, a 2018 randomized controlled trial [1] involving 120 participants observed significant decreases in total cholesterol with safflower oil supplementation.

Despite promising data, large-scale, long-term studies are scarce, limiting definitive health benefit claims.

How Is the Market for Safflower Oil Evolving?

Current Market Size

• The global market for safflower oil was valued at approximately USD 600 million in 2022.
• It is projected to expand at a compound annual growth rate (CAGR) of 6% over the next five years.
• North America accounts for roughly 45% of sales, followed by Europe at 25%, and Asia-Pacific at 20%.

Market Drivers

• Rising consumer demand for plant-based, omega-6 fatty acid sources.
• Growing interest in natural remedies for heart health.
• Food industry adoption as a cooking oil and supplement ingredient.

Segment Breakdown

Segment	Market Share (2022)	Key Applications
Food Industry	70%	Cooking oils, dressings
Dietary Supplements	20%	Capsules, softgels
Cosmetics	10%	Skin oils, lotions

Competitive Landscape

• Largest producers: Cargill Inc., Archer Daniels Midland, and various regional players.
• Private label brands expanding in health stores.
• Suppliers focus on GMO-free, organic safflower oil to meet premium consumer demands.

What Are the Market Projections and Key Future Trends?

Growth Projections

• The safflower oil market is expected to reach USD 900 million by 2027.
• CAGR of approximately 6% from 2022 to 2027.

Future Industry Trends

• Increased demand for organic and non-GMO safflower oils.
• Expansion into functional foods and nutraceutical formulations.
• Potential for pharmaceutical development targeting lipid disorders, contingent upon clinical trial outcomes.

Regulatory Environment

• Generally recognized as safe (GRAS) status by the FDA.
• Market expansion facilitated by favorable regulatory policies in key regions.
• Ongoing scrutiny of omega-6 fatty acids' health impacts may influence future regulation.

Summary of Key Data

Aspect	Data
Clinical Trials	20+ registered, mixed results, ongoing studies
Market Size (2022)	USD 600 million
Projected Size (2027)	USD 900 million
CAGR	6%.
Major Players	Cargill Inc., Archer Daniels Midland
Consumer Trends	Organic, GMO-free, supplement and food sectors

What Is the Impact of Ongoing Research on Market Potential?

Positive results in lipid management and cardiovascular health could broaden safflower oil applications in pharmaceuticals. However, current clinical evidence remains limited, which hampers aggressive market expansion driven by health claims. Companies investing in further research could unlock additional market segments.

Key Takeaways

• Clinical evidence supports safflower oil's lipid-lowering effects but lacks large-scale validation.
• The global market is growing steadily, driven by consumer interest in plant-based oils.
• Market expansion hinges on product quality (organic, GMO-free) and research demonstrating clear health benefits.
• Regulatory status remains supportive but subject to scrutiny as scientific understanding evolves.
• Future growth depends on the success of ongoing clinical trials and product innovation.

FAQs

1. Are there any FDA-approved health claims for safflower oil?
No, the FDA has not authorized specific health claims for safflower oil. It is classified as Generally Recognized as Safe (GRAS).

2. What are the main health benefits associated with safflower oil?
Studies indicate potential LDL cholesterol reduction and anti-inflammatory effects, primarily due to high linoleic acid content.

3. How does safflower oil compare to other plant oils?
It has a higher omega-6 fatty acid content compared to olive or coconut oils and is used mainly for its lipid profile benefits.

4. What are the key challenges for market growth?
Limited long-term clinical data and regulatory uncertainties around omega-6 fatty acids' health effects.

5. What regions are expected to drive future market growth?
North America and Europe, due to high health awareness and demand for functional foods, with emerging markets in Asia-Pacific.

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Sources

[1] Johnson, M., et al. (2018). Effects of safflower oil on lipid profile: A randomized controlled trial. Journal of Clinical Lipidology, 12(4), 812-818.