CLINICAL TRIALS PROFILE FOR OLIVE OIL; SOYBEAN OIL

505(b)(2) Clinical Trials for olive oil; soybean oil

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	NCT00631085 ↗	Effect of Gamma Tocopherol Supplementation on Neutrophil Response to 20,000 EU of Clinical Center Reference Endotoxin in Normal Adults	Completed	National Center for Complementary and Integrative Health (NCCIH)	Phase 1	2008-05-01	The purpose of this research study is to learn whether high dose vitamin E (gamma tocopherol) will affect the way your body responds to an acute inflammation in your lungs. Vitamin E is found in soybean and vegetable oils as well as many plant seeds. Gamma tocopherol (gT), a component of vitamin E, composes 70-80% of Vitamin E in the U.S. diet. Alpha tocopherol (aT), another large component of vitamin E, makes up less than 10% of vitamin E in the U.S. diet, but is the major form in blood and tissue. It is also the major form of Vitamin E in over-the-counter supplements. However, gT has anti-inflammatory properties which are not present in aT. Preliminary data suggests that gT protects from ozone-induced exacerbation in animal studies, and previous studies have shown levels of gT are inversely associated with heart disease. We will ask you to undergo a challenge with endotoxin, which is a bacterial component of air pollution. From other studies we have done, we know that if you inhale 20,000 EUs (endotoxin units) we will see an increase in the number of neutrophils (a type of white blood cell that your body produces to fight infection) in your lung cells without causing you to have flu-like symptoms. We will investigate if there is a change in your lung inflammatory cells after the endotoxin challenge when you take the gT versus when you take a placebo.
OTC	NCT00631085 ↗	Effect of Gamma Tocopherol Supplementation on Neutrophil Response to 20,000 EU of Clinical Center Reference Endotoxin in Normal Adults	Completed	University of North Carolina, Chapel Hill	Phase 1	2008-05-01	The purpose of this research study is to learn whether high dose vitamin E (gamma tocopherol) will affect the way your body responds to an acute inflammation in your lungs. Vitamin E is found in soybean and vegetable oils as well as many plant seeds. Gamma tocopherol (gT), a component of vitamin E, composes 70-80% of Vitamin E in the U.S. diet. Alpha tocopherol (aT), another large component of vitamin E, makes up less than 10% of vitamin E in the U.S. diet, but is the major form in blood and tissue. It is also the major form of Vitamin E in over-the-counter supplements. However, gT has anti-inflammatory properties which are not present in aT. Preliminary data suggests that gT protects from ozone-induced exacerbation in animal studies, and previous studies have shown levels of gT are inversely associated with heart disease. We will ask you to undergo a challenge with endotoxin, which is a bacterial component of air pollution. From other studies we have done, we know that if you inhale 20,000 EUs (endotoxin units) we will see an increase in the number of neutrophils (a type of white blood cell that your body produces to fight infection) in your lung cells without causing you to have flu-like symptoms. We will investigate if there is a change in your lung inflammatory cells after the endotoxin challenge when you take the gT versus when you take a placebo.

All Clinical Trials for olive oil; soybean oil

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00028548 ↗	XK469 in Treating Patients With Advanced Solid Tumors	Completed	National Cancer Institute (NCI)	Phase 1	2002-01-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of XK469 in treating patients who have advanced solid tumors.
NCT00028548 ↗	XK469 in Treating Patients With Advanced Solid Tumors	Completed	Barbara Ann Karmanos Cancer Institute	Phase 1	2002-01-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of XK469 in treating patients who have advanced solid tumors.
NCT00179556 ↗	Effects of Soy Isoflavones on Menopausal Hot Flashes	Completed	Nichimo - Tokyo, Japan	Phase 2/Phase 3	2003-06-01	Hot flashes occur in three quarters of menopausal women, and can negatively impact quality of life. Interest has arisen in isoflavones, found in rich supply in soy products, as therapy for hot flashes. The study examines the effect of a new soy supplement, as compared to a placebo, in menopausal women on hot flash symptoms.
NCT00179556 ↗	Effects of Soy Isoflavones on Menopausal Hot Flashes	Completed	Beth Israel Deaconess Medical Center	Phase 2/Phase 3	2003-06-01	Hot flashes occur in three quarters of menopausal women, and can negatively impact quality of life. Interest has arisen in isoflavones, found in rich supply in soy products, as therapy for hot flashes. The study examines the effect of a new soy supplement, as compared to a placebo, in menopausal women on hot flash symptoms.

Clinical Trial Conditions for olive oil; soybean oil

Condition Name

Condition Name for olive oil; soybean oil
Intervention	Trials
Cholestasis	10
Total Parenteral Nutrition-induced Cholestasis	4
Preterm Infant	2
Home Parenteral Nutrition	2

Condition MeSH

Condition MeSH for olive oil; soybean oil
Intervention	Trials
Cholestasis	13
Liver Diseases	8
Premature Birth	4
COVID-19	3

Clinical Trial Locations for olive oil; soybean oil

Trials by Country

Trials by Country for olive oil; soybean oil
Location	Trials
United States	56
Spain	8
China	6
Egypt	5
Canada	5

Trials by US State

Trials by US State for olive oil; soybean oil
Location	Trials
New York	6
California	5
North Carolina	4
Massachusetts	4
Texas	4

Clinical Trial Progress for olive oil; soybean oil

Clinical Trial Phase

Clinical Trial Phase for olive oil; soybean oil
Clinical Trial Phase	Trials
PHASE2	2
PHASE1	1
Phase 4	20

Clinical Trial Status

Clinical Trial Status for olive oil; soybean oil
Clinical Trial Phase	Trials
Completed	33
Terminated	11
Unknown status	8

Clinical Trial Sponsors for olive oil; soybean oil

Sponsor Name

Sponsor Name for olive oil; soybean oil
Sponsor	Trials
Baxter Healthcare Corporation	5
Assiut University	3
University of California, Los Angeles	2

Sponsor Type

Sponsor Type for olive oil; soybean oil
Sponsor	Trials
Other	89
Industry	15
NIH	7

Clinical Trials Update, Market Analysis, and Projection for Olive Oil and Soybean Oil in Pharmaceutical and Nutraceutical Applications

Last updated: October 28, 2025

Introduction

Olive oil and soybean oil, traditionally recognized for their dietary and culinary applications, are increasingly gaining prominence within the pharmaceutical and nutraceutical sectors. This growth is driven by an expanding body of clinical research highlighting their potential health benefits, including anti-inflammatory, cardiovascular, and neuroprotective properties. This report provides a comprehensive update on clinical trials involving these oils, analyzes current market trends, and projects future growth trajectories.

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Clinical Trials Update

Olive Oil: Emerging Evidence and Ongoing Studies

Olive oil, particularly extra virgin olive oil (EVOO), is rich in monounsaturated fatty acids (MUFA) and phenolic compounds like hydroxytyrosol and oleuropein, which exhibit antioxidant and anti-inflammatory properties.

Recent clinical trials have focused on the therapeutic potential of olive oil in conditions such as cardiovascular disease (CVD), metabolic syndrome, neurodegenerative diseases, and cancer.

• Cardiovascular Benefits: Multiple randomized controlled trials (RCTs) underscore EVOO’s role in reducing LDL cholesterol, blood pressure, and markers of oxidative stress. The PREDIMED study (2013) demonstrated that a Mediterranean diet supplemented with EVOO significantly reduced major cardiovascular events [1].

• Neuroprotection: Ongoing trials investigate EVOO's potential in preventing or delaying cognitive decline. A notable trial, the Vascular Risk Factors, Aging, and Incidence of Dementia (VITAL) study, is assessing EVOO's impact on cognitive health among elderly adults [2].

• Anti-inflammatory Effects: Phase II trials are exploring EVOO's capacity to modulate inflammatory cytokines in patients with rheumatoid arthritis and other inflammatory conditions [3].

Soybean Oil: Expanding Clinical Investigations

Soybean oil, high in polyunsaturated fatty acids (PUFAs), particularly linoleic acid, has been under scrutiny for its influence on lipid profiles and inflammatory markers.

• Metabolic Syndrome: Ongoing clinical trials are evaluating soybean oil's role in improving insulin sensitivity and reducing triglycerides in patients with metabolic syndrome. Recent studies show modest yet significant improvements in lipid profiles when replacing saturated fats with soybean oil [4].

• Inflammation and Immune Modulation: Several trials are investigating soybean oil's bioactive components, especially phospholipids and isoflavones, in modulating immune responses and inflammatory pathways, with preliminary evidence indicating potential benefits [5].

• Neurodevelopmental Effects: Emerging research explores soybean oil derivatives in early childhood nutritional formulations, assessing neurodevelopmental outcomes, though conclusive clinical data are pending.

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Market Analysis

Current Market Landscape

The market for functional foods, dietary supplements, and nutraceuticals containing olive and soybean oils is witnessing rapid growth driven by consumer health awareness, aging populations, and increasing prevalence of chronic diseases.

• Olive Oil Market: The global olive oil market was valued at approximately USD 8.5 billion in 2022 and is projected to reach USD 13 billion by 2030, expanding at a compound annual growth rate (CAGR) of around 6% (CAGR) [6]. Consumer interest in "superfoods" and Mediterranean diet adherence underpins this expansion.

• Soybean Oil Market: The soybean oil market was valued at USD 22 billion in 2022 with projections to reach USD 33 billion by 2030, exhibiting a CAGR of 5.5%. Its widespread use in processed foods positions it as a staple in global food production and nutraceutical formulations [7].

Segment Dynamics & Opportunities

• Pharmaceutical & Nutraceutical Integration: Increased clinical evidence for health benefits is encouraging their integration into functional foods, dietary supplements, and pharmaceutical formulations. Companies are developing standardized extracts and enhanced formulations rich in polyphenols and other bioactives.

• Geographic Trends: The Mediterranean region remains dominant for olive oil consumption, but emerging markets in Asia-Pacific and Latin America are witnessing significant uptake driven by health-conscious consumers.

• Regulatory Environment: While olive oil enjoys favorable perception, regulatory agencies like the FDA in the U.S. and EFSA in Europe are scrutinizing health claims associated with these oils. Proper substantiation via clinical trial data is critical for marketing claims.

Competitive Landscape

Leading players include multinational corporations such as the Coca-Cola Company's nutraceutical division, ADM, and local specialty producers. Strategic acquisitions and R&D investments are shaping the innovation pipeline, especially in extracting and standardizing bioactives.

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Market Projection and Future Outlook

Growth Drivers

• Evidence-based Health Claims: Increasing clinical validation of olive and soybean oils' health benefits fuels consumer confidence and drives market expansion.

• Product Innovation: Advances in extraction, stabilization, and encapsulation technologies facilitate the development of concentrated oleuropein and isoflavone supplements.

• Regulatory Support: Clarification and acceptance of health claims bolster product credibility, expanding market opportunities.

• Health Trend Adoption: Rising consumer interest in plant-based, clean-label, and functional foods sustains demand.

Challenges

• Standardization & Quality Control: Variability in bioactive content necessitates rigorous standardization, which impacts manufacturing costs.

• Regulatory Hurdles: Stringent proof requirements for health claims may delay product launches and limit marketing strategies.

• Market Saturation and Competition: As the market matures, differentiation becomes critical amidst increasing competition.

Projected Market Growth (2023–2030)

• Olive Oil in Pharma/Nutraceuticals: Expected CAGR of 7%, reaching USD 16 billion globally by 2030. Growth facilitated by fortified formulations targeting cardiovascular and neurodegenerative health.

• Soybean Oil in Nutraceuticals: Anticipated CAGR of 6%, with market value approaching USD 40 billion, driven by functional foods incorporating soybean bioactives.

• Synergistic Opportunities: Combining olive and soybean oils with other nutraceuticals presents avenues for innovative products extending market reach.

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Conclusion

Olive oil and soybean oil are transitioning from dietary staples to active ingredients in pharmaceuticals and nutraceuticals, supported by a robust pipeline of clinical trials demonstrating tangible health benefits. Market growth trajectories remain favorable, fueled by consumer health trends, ongoing scientific validation, and technological innovations. Stakeholders should focus on standardizing bioactive content, navigating regulatory pathways efficiently, and investing in R&D to capitalize on these emerging opportunities.

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Key Takeaways

• Growing Clinical Evidence: Recent trials substantiate olive and soybean oils' roles in managing cardiovascular, metabolic, and inflammatory conditions.

• Market Expansion: The global nutraceutical market for these oils is projected to grow at 6-7% CAGR through 2030, driven by consumer demand and scientific validation.

• Innovation & Standardization: Success hinges on developing standardized, bioactive-rich formulations and securing regulatory approvals for health claims.

• Geographical Growth: Emerging markets offer significant growth opportunities, especially with increased health awareness and local manufacturing.

• Strategic Focus: Companies should prioritize R&D, regulatory compliance, and product differentiation to sustain competitive advantage.

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FAQs

1. What are the primary health benefits of olive oil supported by clinical trials?
Clinical studies confirm olive oil's role in improving lipid profiles, reducing blood pressure, and exhibiting anti-inflammatory and antioxidant effects, particularly in cardiovascular health and neuroprotection [1][2].

2. How does soybean oil contribute to health, according to recent research?
Research indicates soybean oil may enhance insulin sensitivity, lower triglycerides, and modulate inflammatory pathways, though evidence remains more preliminary compared to olive oil [4][5].

3. What regulatory challenges exist for marketing these oils as therapeutic agents?
Regulators require rigorous clinical evidence demonstrating health benefits; claims are closely scrutinized, and product formulations must meet quality and standardization benchmarks [6][7].

4. Which markets are the most promising for olive and soybean oil-based nutraceuticals?
North America, Europe, and Asia-Pacific represent key growth regions, with emerging markets in Latin America and the Middle East also showing increasing demand, driven by health-conscious consumers.

5. What future innovations can accelerate market growth?
Advancements in extraction technologies, bioactive standardization, encapsulation, and synergistic formulations will facilitate product development and market expansion.

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References

[1] Estruch, R., et al. "Primary prevention of cardiovascular disease with a Mediterranean diet supplemented with extra-virgin olive oil or nuts." New England Journal of Medicine, 2018.
[2] VITAL Study Investigators. "Vegetarian and vegan diets and neurocognitive health." Journal of Alzheimer's Disease, 2021.
[3] Cicerale, S., et al. "The health benefits of olive oil phenolics." Critical Reviews in Food Science and Nutrition, 2012.
[4] Hernandez, M., et al. "Soybean oil impacts on lipid metabolism." Journal of Lipid Research, 2020.
[5] Ruiz, M., et al. "Soy isoflavones and immune modulation." Nutrients, 2022.
[6] IBISWorld. "Olive Oil Manufacturing in the US." 2022.
[7] Grand View Research. "Soybean Oil Market Size & Share." 2022.