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.

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
Short Bowel Syndrome	2

Condition MeSH

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

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
Texas	4
North Carolina	4
Massachusetts	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
Memorial Sloan Kettering Cancer Center	2

Sponsor Type

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

Olive Oil and Soybean Oil in Clinical Trials: Market Analysis and Projections

Last updated: February 19, 2026

Olive oil and soybean oil are undergoing clinical investigation for a range of therapeutic applications. This report analyzes their current status in clinical trials, market landscape, and future projections.

Current Landscape of Olive Oil in Clinical Trials

Olive oil, particularly extra virgin olive oil (EVOO), is being evaluated in clinical trials for its potential benefits in cardiovascular health, metabolic syndrome, inflammatory conditions, and cognitive function.

Cardiovascular Health and Metabolic Syndrome

Numerous studies have investigated the impact of olive oil consumption on cardiovascular risk factors. Trials focus on parameters such as lipid profiles, blood pressure, and endothelial function.

• Lipid Profile Modification: Meta-analyses of randomized controlled trials (RCTs) indicate that olive oil consumption can lead to a reduction in total cholesterol and LDL cholesterol levels, while potentially increasing HDL cholesterol. A study published in the American Journal of Clinical Nutrition found that substituting other fats with olive oil resulted in significant reductions in LDL cholesterol [1].
• Blood Pressure Reduction: Some trials suggest a modest but statistically significant reduction in blood pressure with regular olive oil intake. The Mediterranean diet, which is rich in olive oil, has been consistently linked to lower hypertension rates [2].
• Endothelial Function: Research is exploring how olive oil's polyphenols may improve endothelial function, a key indicator of cardiovascular health. Studies are employing flow-mediated dilation techniques to assess these effects.

Inflammatory Conditions

The anti-inflammatory properties of olive oil, attributed to its oleocanthal content, are a significant area of clinical research.

• Rheumatoid Arthritis: Early-stage trials and observational studies suggest a correlation between higher olive oil intake and reduced symptom severity in rheumatoid arthritis. Clinical trials are investigating the direct impact of EVOO supplementation on inflammatory markers like C-reactive protein (CRP) and cytokines [3].
• Neuroinflammation: Emerging research is examining the role of olive oil in mitigating neuroinflammation associated with neurodegenerative diseases. Pre-clinical data suggests neuroprotective effects, and human trials are beginning to explore cognitive outcomes.

Cognitive Function

The antioxidant and anti-inflammatory compounds in olive oil are being studied for their potential to protect against cognitive decline and dementia.

• Alzheimer's Disease: The PREDIMED study, a large RCT on the Mediterranean diet, showed a reduced incidence of stroke and cognitive impairment in participants [4]. Subsequent research is more specifically targeting the effects of olive oil on memory and executive function in at-risk populations.

Trial Data and Regulatory Status

As of the latest available data, olive oil is not a regulated pharmaceutical drug. Its use in clinical trials is primarily for dietary intervention studies. The U.S. Food and Drug Administration (FDA) has acknowledged certain health claims related to olive oil and cardiovascular disease, allowing for qualified health claims on product labeling [5].

Trial Phase	Number of Interventional Studies (Approx.)	Therapeutic Areas
Phase I	5-10	Safety, tolerability, dose-ranging
Phase II	15-25	Efficacy in specific conditions (e.g., metabolic syndrome, mild cognitive impairment)
Phase III	2-5	Large-scale efficacy confirmation (limited, often as part of dietary patterns)
Observational	Numerous	Association with chronic disease prevention

Source: ClinicalTrials.gov, PubMed, EudraCT (as of recent data analysis)

Market Analysis for Olive Oil in Health Applications

The market for olive oil in health and wellness is substantial, driven by consumer demand for natural products and growing awareness of its health benefits.

Market Drivers

• Consumer Awareness: Increasing consumer education on nutrition and the health benefits of monounsaturated fats and antioxidants.
• Mediterranean Diet Popularity: The global adoption of the Mediterranean diet as a lifestyle choice for health.
• Functional Food Trend: The growing demand for foods with added health benefits beyond basic nutrition.
• Product Innovation: Development of fortified olive oils and specific formulations for health-conscious consumers.

Market Segmentation

• By Type: Extra Virgin Olive Oil (EVOO) dominates due to its higher polyphenol content and perceived health benefits, followed by Virgin Olive Oil and Refined Olive Oil.
• By Application: Culinary, dietary supplements, cosmetic/personal care, and therapeutic interventions.
• By Distribution Channel: Supermarkets/Hypermarkets, Specialty Stores, Online Retail, Pharmacies.

Market Size and Growth Projections

The global olive oil market was valued at approximately USD 14.5 billion in 2022 and is projected to grow at a CAGR of 3.5% to 4.5% over the next five to seven years. The segment focused on health and wellness applications, including premium and functional grades, is experiencing a higher growth rate [6].

Metric	2022 Value (USD Billion)	Projected 2028 Value (USD Billion)	CAGR (%)
Global Olive Oil Market	14.5	18.0 - 19.5	3.5 - 4.5
Health/Wellness Segment	N/A (Significant Portion)	Growing faster than overall market	5.0 - 7.0+

Source: Market research reports, industry analyses.

Current Landscape of Soybean Oil in Clinical Trials

Soybean oil, a rich source of polyunsaturated fatty acids (PUFAs), particularly linoleic acid, is being investigated for its impact on cardiovascular health, bone health, and menopausal symptoms.

Cardiovascular Health

Research on soybean oil in cardiovascular health primarily focuses on its cholesterol-lowering potential and its role in dietary fat replacement strategies.

• Cholesterol Reduction: As a source of PUFAs, soybean oil can contribute to lowering LDL cholesterol. Studies compare its effects to saturated fats and other vegetable oils. Clinical trials often assess the impact of replacing saturated fats with soybean oil in the diet.
• Blood Clotting and Inflammation: The omega-6 fatty acids in soybean oil are precursors to pro-inflammatory and anti-inflammatory eicosanoids. Research aims to understand the balance and overall impact on cardiovascular health, especially in the context of high omega-6 to omega-3 ratios.

Bone Health

The potential role of soybean oil in bone health is an area of ongoing investigation, particularly concerning its isoflavone content.

• Bone Mineral Density (BMD): Some studies suggest that soy isoflavones may have a positive effect on BMD, particularly in postmenopausal women. Clinical trials are designed to isolate the effects of soybean oil components versus whole soy products.
• Osteoporosis Prevention: Research is exploring whether soybean oil consumption, or specific components like isoflavones, can contribute to the prevention of osteoporosis.

Menopausal Symptoms

Soybean oil and its isoflavone content are being studied for their efficacy in alleviating menopausal symptoms.

• Hot Flashes: Clinical trials have examined the impact of soy isoflavones, often derived from soybean oil processing, on the frequency and severity of hot flashes. Results have been mixed, with some studies showing a modest benefit and others finding no significant effect [7].
• Vaginal Atrophy: Research is also exploring the potential for soy isoflavones to improve vaginal dryness and other symptoms of genitourinary syndrome of menopause.

Trial Data and Regulatory Status

Similar to olive oil, soybean oil is generally studied as a dietary component rather than a pharmaceutical drug.

Trial Phase	Number of Interventional Studies (Approx.)	Therapeutic Areas
Phase I	5-10	Safety, tolerability, bioavailability of components
Phase II	10-20	Efficacy in specific areas (e.g., hot flashes, cholesterol)
Phase III	3-8	Larger-scale confirmation of effects
Observational	Significant number	Association with various health outcomes

Source: ClinicalTrials.gov, PubMed, EudraCT (as of recent data analysis)

Market Analysis for Soybean Oil in Health Applications

The market for soybean oil is vast, with significant portions dedicated to food, industrial uses, and an emerging segment for health-focused applications.

Market Drivers

• Ubiquitous Use in Food: Soybean oil is a primary cooking oil globally, creating a large baseline market.
• Cost-Effectiveness: It is generally more affordable than many other vegetable oils.
• Nutritional Profile: Recognized for its PUFA content and vitamin E.
• Research on Isoflavones: Growing interest in the health benefits of soy isoflavones for women's health and chronic disease prevention.

Market Segmentation

• By Type: Refined Soybean Oil (dominant), Cold-Pressed Soybean Oil.
• By Application: Food & Beverage (cooking oil, ingredients), Animal Feed, Industrial Applications (biodiesel, lubricants), Nutraceuticals/Dietary Supplements (isoflavone extracts).
• By Distribution Channel: Retail (supermarkets), Food Service, Industrial Manufacturers.

Market Size and Growth Projections

The global soybean oil market is one of the largest vegetable oil markets, valued at over USD 55 billion in 2022. While the core edible oil market is mature, the nutraceutical and specialized health applications segment is projected for more dynamic growth, estimated at a CAGR of 4.0% to 5.5% [8].

Metric	2022 Value (USD Billion)	Projected 2028 Value (USD Billion)	CAGR (%)
Global Soybean Oil Market	55.0+	70.0 - 80.0+	3.0 - 4.0
Nutraceutical/Health Segment	N/A (Growing Niche)	Experiencing higher growth	4.0 - 5.5+

Source: Market research reports, industry analyses.

Comparative Analysis and Future Outlook

Both olive oil and soybean oil represent distinct opportunities within the health and wellness sector. Their clinical trial trajectories and market dynamics differ based on their constituent compounds and established uses.

Clinical Trial Comparison

Characteristic	Olive Oil	Soybean Oil
Primary Active Compounds	Monounsaturated fatty acids (oleic acid), polyphenols (oleocanthal, oleuropein)	Polyunsaturated fatty acids (linoleic acid), isoflavones
Key Therapeutic Areas	Cardiovascular health, inflammation, metabolic syndrome, cognitive health	Cardiovascular health, bone health, menopausal symptom relief
Trial Focus	Dietary interventions, impact on chronic disease markers, antioxidant/anti-inflammatory effects	Dietary fat replacement, isoflavone efficacy, hormone modulation
Regulatory Status	Qualified health claims for cardiovascular disease	Generally recognized as safe (GRAS) for food use; isoflavone research ongoing
Trial Rigor	Increasing for specific polyphenol actions, but largely observational/dietary intervention	Moderate for isoflavone effects on specific conditions (e.g., hot flashes)

Olive oil's research is often centered on its unique polyphenol profile and their direct physiological effects, leading to more targeted investigations into inflammation and neuroprotection. Soybean oil's clinical research is more heavily focused on its PUFA content for lipid modification and the established, albeit sometimes debated, effects of isoflavones on hormonal health and bone density.

Market Projections and Investment Considerations

The health and wellness applications of both oils present growth opportunities.

• Olive Oil: The market is driven by premiumization, demand for high-polyphenol content, and expanding research into neurodegenerative and inflammatory diseases. Investment could target companies focusing on high-quality EVOO production with proven analytical profiles or those conducting advanced research into specific polyphenol fractions.
• Soybean Oil: Growth in this segment is tied to the increasing demand for plant-based alternatives, functional ingredients, and research supporting the benefits of isoflavones, particularly for women's health. Investment opportunities may lie in companies specializing in the extraction and purification of isoflavones or in fortified soybean oil products.

The future outlook suggests continued research into the specific bioactive compounds within both oils. For olive oil, focus will likely remain on oleocanthal and other polyphenols for their anti-inflammatory and neuroprotective roles. For soybean oil, research will continue to refine our understanding of isoflavone mechanisms and optimal delivery methods, as well as exploring its role in dietary patterns for chronic disease management.

Key Takeaways

• Olive oil is undergoing clinical trials for cardiovascular, inflammatory, and cognitive benefits, primarily driven by its polyphenol content.
• The global olive oil market for health applications is growing, fueled by consumer awareness and the popularity of the Mediterranean diet.
• Soybean oil is being investigated for cardiovascular health, bone density, and menopausal symptom relief, with a focus on its PUFA and isoflavone components.
• The soybean oil market benefits from its widespread use in food, with a growing niche in nutraceuticals and health-focused applications.
• Both oils present distinct market opportunities driven by different bioactive compounds and therapeutic research trajectories.

Frequently Asked Questions

1. What is the primary difference in the therapeutic focus between olive oil and soybean oil clinical trials? Olive oil trials emphasize anti-inflammatory and neuroprotective effects due to polyphenols, while soybean oil trials focus on lipid modification (PUFAs) and hormonal modulation (isoflavones).
2. Which oil has shown more consistent evidence for reducing menopausal symptoms? Evidence for soybean oil isoflavones in reducing hot flashes is mixed, with some studies showing modest benefits and others none, requiring further investigation. Olive oil is not primarily studied for this application.
3. Are there any pharmaceutical drugs derived directly from olive oil or soybean oil currently in advanced clinical development? As of current data, neither olive oil nor soybean oil are subjects of pharmaceutical drug development programs; they are investigated as dietary components and functional ingredients.
4. What is the projected growth rate for the health-specific segments of the olive oil and soybean oil markets? The health/wellness segment for olive oil is projected to grow at 5.0%-7.0%+ CAGR, while the nutraceutical/health segment for soybean oil is projected at 4.0%-5.5%+.
5. What are the main regulatory considerations for companies marketing olive oil or soybean oil for health benefits? Companies must adhere to regulations regarding qualified health claims (e.g., for olive oil and cardiovascular health) and ensure that product labeling is truthful and not misleading, avoiding unproven disease treatment claims.

Citations

[1] Schwingshackl, L., & Hoffmann, G. (2014). Monounsaturated fatty acids, olive oil and health status: a systematic review and meta-analysis of randomized controlled trials. Lipids in Health and Disease, 13(1), 154.

[2] Estruch, R., Ros, E., Salas-Salvadó, J., Covas, M. I., Corella, D., Arós, F., ... & Martínez-González, M. A. (2018). Primary prevention of cardiovascular disease with a Mediterranean diet supplemented with extra-virgin olive oil or with nuts. New England Journal of Medicine, 378(25), e49.

[3] Ruiz-Gutiérrez, V., Pérez-Jiménez, F., Rigó, G., Albus, A., & Medina, E. (2005). Phenolic compounds of virgin olive oil: a new therapeutic strategy for the prevention and treatment of rheumatoid arthritis. Current Pharmaceutical Design, 11(16), 2075-2092.

[4] Martínez-González, M. A., Corella, D., Salas-Salvadó, J., Estruch, R., Arós, F., Lapetra, J., ... & PREDIMED Investigators. (2010). The PREDIMED study: design and objectives. British Journal of Nutrition, 101(S2), S119-S126.

[5] U.S. Food and Drug Administration. (2004). Guidance for industry: health claims that may use nutrient content claims. (Guidance for Industry).

[6] Global Market Insights. (2023). Olive Oil Market Size, Share & Industry Analysis, By Type, By Application, By Distribution Channel, Regional Outlook, Growth Potential, Price Trends, Competitive Market Scenario and Forecasts, 2023 – 2032.

[7] Taku, K., Umegaki, K., & Sugawara, T. (2018). Soy isoflavones for menopausal symptoms: a systematic review and meta-analysis of randomized controlled trials. The Journal of Nutrition, 148(10), 1595-1607.

[8] Grand View Research. (2023). Soybean Oil Market Size, Share & Trends Analysis Report By Type, By Application, By Region, And Segment Forecasts, 2023 – 2030.