Dietary Fats for Vascular Health

(PPMS Trial)

Overseen By Ellen Bonnel, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: USDA, Western Human Nutrition Research Center

Must not be taking: Steroids, Statins, Anti-inflammatories, others

Disqualifiers: Diabetes, Cardiovascular disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how different dietary fats affect certain immune cells in the blood after a high-fat meal. Researchers will test how non-classical monocytes react to meals rich in either saturated fats (such as those in palm oil) or mono-unsaturated fats (such as those in olive oil). Participants will try both meal types in different sequences. Suitable candidates should have a BMI between 18.5 and 29.9 and no chronic diseases requiring daily medication. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on dietary fats and immune health.

Do I have to stop taking my current medications for the trial?

Yes, if you are taking daily medication for chronic diseases or medications that affect the study's endpoints, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that consuming olive oil, rich in healthy fats, links to better heart health. Studies have found that people who use more olive oil have a lower risk of heart disease and may even live longer. These healthy fats help lower bad cholesterol, benefiting the heart.

In contrast, palm oil, high in unhealthy fats, might not be as heart-friendly. Research suggests these fats can raise bad cholesterol levels, possibly increasing the risk of heart problems. Experts advise keeping the intake of these unhealthy fats low to maintain good heart health.

The trial is studying both types of fats to see how they affect certain immune cells in the blood after consumption. While olive oil appears safe and beneficial for heart health, palm oil could pose risks due to its unhealthy fat content. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these dietary interventions because they explore how different types of fats—mono-unsaturated fats from olive oil and saturated fats from palm oil—impact vascular health. Unlike traditional treatments that might involve medications or supplements, this approach looks at the natural influence of dietary choices on blood vessels. By comparing these two types of fats, scientists hope to understand better which could be more beneficial for heart health, potentially offering a simple, everyday dietary strategy to improve vascular condition.

What evidence suggests that this trial's treatments could be effective for vascular health?

This trial will compare the effects of different dietary fats on vascular health. Participants will receive either a high mono-unsaturated fat challenge meal with olive oil or a high saturated fat challenge meal with palm oil. Research has shown that olive oil, rich in healthy fats, benefits heart health. Studies have found that it can lower the risk of heart disease, help maintain healthy cholesterol levels, and protect blood vessels. Additionally, consuming olive oil is linked to a reduced risk of type 2 diabetes.

Conversely, palm oil, which contains more saturated fats, has mixed reviews regarding heart health. Some studies suggest it might benefit the heart and blood vessels, while others find no clear advantages in reducing saturated fats. Saturated fats, like those in palm oil, can raise bad cholesterol (LDL-C), potentially harming heart health. ^{6 7 8 9 10}

Who Is on the Research Team?

Ryan Snodgrass, PhD

Principal Investigator

USDA, Western Human Nutrition Research Center

Are You a Good Fit for This Trial?

This study is for healthy adults aged 18-39 with a BMI of 18.5 to 29.9, who have no allergies to meal ingredients and no chronic diseases requiring daily medication. Participants must not be on certain medications, pregnant, or have recent surgeries or hospitalizations.

Inclusion Criteria

BMI 18.5 - 29.9 kg/m²

Must have a bank account and social security number or taxpayer identification for financial compensation

Exclusion Criteria

Triglycerides above 150 mg/dL

Unable to fast for 12 hours

Fasting glucose above 105 mg/dL

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume one of two isocaloric high-fat challenge meals spaced two weeks apart, with blood samples collected at fasting and 6 hours postprandial

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in monocyte subsets and other blood parameters after meal consumption

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High mono unsaturated fat challenge meal
• High saturated fat challenge meal

Trial Overview The trial investigates how two high-fat meals (one rich in saturated fat and the other in mono unsaturated fat) affect immune cells called non-classical monocytes after eating. The focus is on these cells' role in blood vessel health post-meal.

How Is the Trial Designed?

Group I: High saturated fat challenge meal followed by high mono-unsaturated fat challenge meal Experimental Treatment 2 Interventions

High saturated fat mixed macronutrient challenge meal with palm oil followed by high mono-unsaturated fat mixed macronutrient challenge meal with olive oil two weeks later

Group II: High mono-unsaturated fat challenge meal followed by high saturated fat challenge meal Experimental Treatment 2 Interventions

High mono-unsaturated fat mixed macronutrient challenge meal with olive oil followed by high saturated fat mixed macronutrient challenge meal with palm oil two weeks later

Who Is Running the Clinical Trial?

USDA, Western Human Nutrition Research Center

Lead Sponsor

Trials

64

Recruited

19,100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11353474/

Health Outcomes Associated with Olive Oil Intake The primary health benefits of OO were observed in cardiovascular diseases and risk factors, cancer, mortality, diabetes, and specific biomarkers.

2. ahajournals.org ahajournals.org/doi/10.1161/01.cir.100.11.1253

Monounsaturated Fatty Acids and Risk of Cardiovascular ... This report summarizes our current understanding of how monounsaturated fatty acids (MUFAs) affect risk for cardiovascular disease (CVD).

3. sciencedirect.com sciencedirect.com/science/article/pii/S0261561422003557

Effect of olive oil consumption on cardiovascular disease ... Olive oil consumption was associated with a 22% lower relative risk of T2D (RR: 0.78; 95% CI: 0.69 to 0.87, per 25 g/d) without evidence of heterogeneity.

4. e-acnm.org e-acnm.org/journal/view.php?number=276

Efficacy of monounsaturated fatty acids in reducing risk ... A diet high in MUFAs can aid in weight loss and reduce the risk of cardiovascular disease. Olive oil, in particular, has been linked to a lower ...

5. bhooc.com bhooc.com/blogs/articles/olive-oil-and-heart-health-key-clinical-studies?srsltid=AfmBOoomSsbay-yEsB4uhG0LJHX6vhHCRm6buDQdvsO7ZeM29YuN6PqM

Olive Oil and Heart Health: Key Clinical Studies Its high content of monounsaturated fats and antioxidants supports healthy cholesterol levels and protects blood vessels. Key findings include:

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7233327/

Olive Oil Consumption and Cardiovascular Risk in U.S. Adults Higher olive oil intake was associated with lower risk of CHD and total CVD in two large prospective cohorts of U.S. men and women. The substitution of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9623257/

Olive oil consumption and risk of cardiovascular disease ... Olive oil consumption is inversely related to the risk of CVD and all-cause mortality. Such benefits seem to be obtained with an intake of olive oil up to 20 g ...

8. ahajournals.org ahajournals.org/doi/10.1161/cir.0000000000000510

Dietary Fats and Cardiovascular Disease: A Presidential ... The high polyunsaturated, low saturated fat group experienced significantly fewer CVD events, 8 of 51 versus 24 of 51, a 67% reduction, much ...

9. heart.org heart.org/en/healthy-living/healthy-eating/eat-smart/fats/monounsaturated-fats

Monounsaturated Fats Monounsaturated fats can help reduce bad cholesterol levels in your blood, which can lower your risk of heart disease and stroke.

10. medicine.yale.edu medicine.yale.edu/news-article/olive-oil-and-heart-health/

Olive Oil and Heart Health - Yale School of Medicine People who used more than 1/2 tablespoon of olive oil daily in their diet had a 19% lower risk of death from any cause and a 19% lower risk of death from heart ...