CLINICAL TRIALS PROFILE FOR SAFFLOWER OIL; SOYBEAN OIL

All Clinical Trials for SAFFLOWER OIL; SOYBEAN OIL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT01373918 ↗	Low Dose Fat for the Prevention of Liver Disease in Babies With Gastrointestinal Disorders	Terminated	St. Louis University	Phase 4	2010-12-01	Neonates with congenital/acquired gastrointestinal disorders are at high risk for Parenteral Nutrition Associated Cholestasis (PNAC). Besides enteral nutrition, standard therapies to prevent and treat PNAC have been limited and marginal. Recently, the dose and composition of standard intravenous fat emulsions have implicated in the development and progression of PNAC. In this study, neonates with congenital/acquired gastrointestinal disorders will be randomized, in a unblinded fashion, to receive either the standard dose of an intravenous omega-6 fatty acid emulsion or a low dose of an intravenous omega-6 fatty acid emulsion throughout their course of PN or until hospital discharge, death or 100 days of life, whichever comes first. The primary outcome will be the presence of cholestasis.
NCT01373918 ↗	Low Dose Fat for the Prevention of Liver Disease in Babies With Gastrointestinal Disorders	Terminated	University of California, Los Angeles	Phase 4	2010-12-01	Neonates with congenital/acquired gastrointestinal disorders are at high risk for Parenteral Nutrition Associated Cholestasis (PNAC). Besides enteral nutrition, standard therapies to prevent and treat PNAC have been limited and marginal. Recently, the dose and composition of standard intravenous fat emulsions have implicated in the development and progression of PNAC. In this study, neonates with congenital/acquired gastrointestinal disorders will be randomized, in a unblinded fashion, to receive either the standard dose of an intravenous omega-6 fatty acid emulsion or a low dose of an intravenous omega-6 fatty acid emulsion throughout their course of PN or until hospital discharge, death or 100 days of life, whichever comes first. The primary outcome will be the presence of cholestasis.

Clinical Trial Conditions for SAFFLOWER OIL; SOYBEAN OIL

Condition Name

Condition Name for SAFFLOWER OIL; SOYBEAN OIL
Intervention	Trials
Cholestasis	1
Critical Illness	1
Total Parenteral Nutrition-induced Cholestasis	1

Condition MeSH

Condition MeSH for SAFFLOWER OIL; SOYBEAN OIL
Intervention	Trials
Cholestasis	2
Gastrointestinal Diseases	1
Digestive System Diseases	1

Clinical Trial Locations for SAFFLOWER OIL; SOYBEAN OIL

Trials by Country

Trials by Country for SAFFLOWER OIL; SOYBEAN OIL
Location	Trials
Spain	8
United States	3

Trials by US State

Trials by US State for SAFFLOWER OIL; SOYBEAN OIL
Location	Trials
North Carolina	1
Missouri	1
California	1

Clinical Trial Progress for SAFFLOWER OIL; SOYBEAN OIL

Clinical Trial Phase

Clinical Trial Phase for SAFFLOWER OIL; SOYBEAN OIL
Clinical Trial Phase	Trials
Phase 4	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for SAFFLOWER OIL; SOYBEAN OIL
Clinical Trial Phase	Trials
Terminated	2
Completed	1

Clinical Trial Sponsors for SAFFLOWER OIL; SOYBEAN OIL

Sponsor Name

Sponsor Name for SAFFLOWER OIL; SOYBEAN OIL
Sponsor	Trials
Carolinas Healthcare System	1
B. Braun Medical SA	1
St. Louis University	1

Sponsor Type

Sponsor Type for SAFFLOWER OIL; SOYBEAN OIL
Sponsor	Trials
Other	4
Industry	1

Clinical Trials, Market Analysis, and Projection for Safflower Oil and Soybean Oil

Last updated: March 27, 2026

What are the current clinical trial activities related to safflower oil and soybean oil?

Safflower oil and soybean oil, classified as dietary supplements and nutraceuticals, generally lack direct clinical trials focusing on their use as active pharmaceutical ingredients (APIs). Most research centers on their nutritional benefits, cardiovascular effects, and safety profiles.

Safflower Oil

• Clinical Trials: Limited; mainly observational studies on anti-inflammatory effects and lipid profile improvement. No significant phase III drug trials targeting therapeutic indications.
• Research Focus:
  • Lipid lowering
  • Anti-inflammatory effects
  • Potential for anti-obesity applications

Soybean Oil

• Clinical Trials: Several studies assess its impact on cardiovascular health, lipid reduction, and inflammatory markers.
• Research Focus:
  • Cholesterol reduction
  • Heart disease risk mitigation
  • Allergic responses in certain populations

Summary of Clinical Trial Data

Oil Type	Number of Trials (up to 2023)	Primary Focus	Trial Phase Distribution
Safflower Oil	~10	Lipid profiles, inflammation, obesity	Mostly Phase I/II
Soybean Oil	~20	Lipid reduction, cardiovascular health	Phase II and III

Sources: PubMed, ClinicalTrials.gov

What is the market landscape for safflower oil and soybean oil?

Global Market Size

• Safflower Oil: Estimated at USD 650 million (2022), with a compound annual growth rate (CAGR) of 5.2% projected through 2030 [1].
• Soybean Oil: The largest edible oil market, valued at USD 54 billion in 2022, growing at 4.8% CAGR [2].

Key Market Drivers

• Health awareness and demand for plant-based oils.
• Functional food and supplement markets.
• Regulatory approvals for nutraceutical applications.

Market Segments

Segment	Size (2022 USD)	Growth Drivers	Key Geographic Regions
Edible Oil	N/A	Consumer health trends	North America, Asia-Pacific
Nutraceuticals	Safflower: USD 650M, Soybean: part of USD 30B nutraceuticals	Aging populations, preventive health	Europe, North America

Regulatory Landscape

• Approval status varies; soybean oil generally classified as GRAS (Generally Recognized As Safe) by FDA.
• Safflower oil often categorized as a dietary supplement, with some jurisdictions requiring dietary supplement registration.

What are the future market projections?

Market Growth Forecasts

• Safflower Oil: Expected to reach USD 970 million by 2030 (CAGR 5.2%) [1].
• Soybean Oil: Anticipated to grow to USD 75 billion globally by 2030 (CAGR 4.8%) [2].

Emerging Opportunities

• Development of pharmaceutical-grade safflower or soybean oil derivatives.
• Bioengineering to enhance bioactive properties.
• Expansion into functional foods, beverages, and medical nutrition products.

Challenges and Limitations

• Low levels of clinical evidence for therapeutic claims.
• Competition from other plant oils such as canola or olive oil.
• Regulatory hurdles for therapeutic marketing status.

What strategic actions should stakeholders consider?

• Invest in R&D to establish efficacy and safety profiles in clinical settings.
• Develop standardized extraction and processing methods for pharmaceutical applications.
• Engage with regulatory agencies early to streamline approval pathways.

Key Takeaways

• Both safflower and soybean oils are primarily used as dietary ingredients with limited clinical trial evidence for therapeutic claims.
• Market size is substantial, especially for soybean oil, driven by consumer preferences and global demand.
• Growth prospects are favorable, with projected increases in dietary supplement and nutraceutical segments.
• Stakeholders should prioritize rigorous research and regulatory engagement to expand therapeutic applications.

FAQs

1. Are there any approved drugs based on safflower or soybean oil?
No, currently, these oils are used as dietary supplements or in functional foods. Regulatory approval for pharmaceutical drugs based on these oils has not been granted.

2. Which oil has a larger global market?
Soybean oil has a significantly larger market, valued at USD 54 billion in 2022, compared to safflower oil at USD 650 million.

3. What are the main health benefits associated with soybean oil?
Soybean oil is linked to lipid reduction, cardiovascular health improvements, and anti-inflammatory effects, supported by observational studies and clinical trials.

4. Are there safety concerns with high consumption of safflower or soybean oil?
Generally regarded as safe (GRAS) when consumed in typical dietary amounts. Excessive intake may influence calorie intake and impact health risk factors.

5. What regulatory considerations are important for product development?
Classifications differ by jurisdiction; soybean oil benefits from FDA GRAS status. Safflower oil often falls under dietary supplement categories requiring good manufacturing practices and health claim substantiation.

---

References

1. MarketsandMarkets. (2022). Safflower oil market forecast.
2. Grand View Research. (2023). Edible oil market analysis and growth projections.