Dietary Oils for Obesity

(DOSE Trial)

Overseen By Martha A Belury, Ph.D., RD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Must not be taking: Weight loss drugs

Disqualifiers: Heart disease, Diabetes, Cancer, others

Compensation: Varies

Number of Visits: 16

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether foods made with soybean oil or palm oil can alter blood fat levels and body weight in overweight individuals. It aims to determine if participants can adhere to consuming these foods without knowing the type of oil. Suitable candidates for this trial are nonsmokers who feel their weight affects their daily life. As an unphased trial, it offers a unique opportunity to contribute to nutritional research and potentially enhance personal health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude people using medications where consuming the study foods would be a problem. It's best to discuss your medications with the trial team.

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

Research shows that soybean oil might have negative health effects. Studies with mice have linked diets high in soybean oil to obesity and diabetes. Evidence also suggests it could affect gut health and might relate to conditions like anxiety and depression.

Palm oil, however, presents its own issues. Often used in foods, its high saturated fat content raises concerns about heart health.

In this trial, participants will consume foods made with either soybean or palm oil. Despite concerns with both oils, they are common in many everyday foods, indicating general safety for most people when used in moderation. However, potential risks exist, especially for those with specific health concerns. Consulting a healthcare professional before joining any clinical trial is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the treatments in the trial because they explore dietary oils, specifically palm oil and soybean oil, as potential influences on obesity. Unlike typical obesity treatments that often involve medications or surgical interventions, these treatments focus on the everyday foods people consume. Soybean oil, being the experimental treatment, is particularly interesting due to its possible effects on metabolism and inflammation, which are key factors in obesity. Palm oil serves as a comparison, helping to highlight the distinct impacts of soybean oil. This dietary approach could offer a more natural and accessible option for managing obesity.

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

This trial will compare the effects of dietary oils on obesity by testing foods made with either soybean oil or palm oil. Research has shown that soybean oil might not be the best option for managing weight. Studies with mice found that diets high in soybean oil caused more weight gain than those with other oils, like coconut oil. In humans, soybean oil has been linked to increased body weight and larger waist size. Similarly, palm oil, often compared to soybean oil, may have the same effect on body weight. Overall, while both oils are widely used, they might not be ideal for weight loss or management. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for overweight or obese adults aged 25-80 who don't smoke and have a BMI between 25-55. It's not suitable for those with heart, kidney, some liver diseases, cancer, diabetes, thyroid disorders, on certain medications including weight loss ones, pregnant or lactating women, substance abusers, people with food allergies/intolerances or specific dietary restrictions.

Inclusion Criteria

Your body mass index (BMI) is between 25 and 55.

Age 25-80 years old

You do not smoke cigarettes.

Exclusion Criteria

Treatment of current cancer diagnosis or current cancer diagnosis

Current or previous diagnosis of diabetes

Inability to access veins for venipuncture

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume 3 study foods made with either soybean oil or palm oil per day for 4 weeks

4 weeks

Visits at Week 0, Week 2, and Week 4

Crossover

Participants switch to the alternate oil group and consume 3 study foods per day for another 4 weeks

4 weeks

Visits at Week 6 and Week 8

Follow-up

Participants are monitored for changes in blood fatty acid composition and body weight

2 weeks

Visit at Week 10

What Are the Treatments Tested in This Trial?

Interventions

• Palm Oil Foods
• Soybean Oil Foods

Trial Overview The study tests if eating foods made with soybean oil versus palm oil affects body fat composition and weight in overweight individuals. Participants will eat three of these foods daily for four weeks without knowing which oil they're consuming to see if there's a difference.

How Is the Trial Designed?

Group I: Soybean Oil Experimental Treatment 1 Intervention

Consumption of study foods each day made with soybean oil

Group II: Palm Oil Placebo Group 1 Intervention

Consumption of study foods each day made with palm oil

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

Palm oil is nutritionally beneficial and versatile, containing high levels of oleic acid that can help reduce blood cholesterol and improve lipid profiles, making it comparable to olive oil in health benefits.

The unique structure of palm oil allows for better absorption of beneficial fatty acids while minimizing the absorption of saturated fats, contributing to its effectiveness in lowering LDL cholesterol and triglycerides while raising HDL cholesterol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palm oil: a healthful and cost-effective dietary component. Ong, AS., Goh, SH.[2017]

Palm oil, despite being high in saturated fatty acids, does not promote cardiovascular diseases and may actually reduce the risk of arterial thrombosis and atherosclerosis due to its antioxidant content and unique fatty acid composition.

While fresh or refined palm oil can have health benefits, including improved nutrient utilization and immune function, oxidized palm oil poses significant health risks, including adverse effects on lipid profiles and organ toxicity, highlighting the importance of consuming palm oil in its fresh state.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palm oil: biochemical, physiological, nutritional, hematological, and toxicological aspects: a review. Edem, DO.[2022]

Palm oil is not linked to raised blood cholesterol levels and is considered cholesterol-free, with its main saturated fatty acid, palmitic acid, shown to have a neutral effect on cholesterol, especially when LDL receptors are functioning normally.

Feeding studies indicate that palm oil may actually lower blood cholesterol compared to other saturated fat sources like coconut oil and animal fats, and it may also increase HDL levels and reduce platelet aggregation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of palm oil on cardiovascular risk. Chong, YH., Ng, TK.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4511588/

Soybean Oil Is More Obesogenic and Diabetogenic than ... Our results indicate that in mice a diet high in soybean oil is more detrimental to metabolic health than a diet high in fructose or coconut oil.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322008031

Effect of Soy and Soy Isoflavones on Obesity-Related ... In contrast to the effects of soy on weight, soy significantly decreased waist circumference in older ages (MD: −0.36 cm; 95% CI: −0.71, −0.01 cm; P = 0.04), in ...

3. bmcnutr.biomedcentral.com bmcnutr.biomedcentral.com/articles/10.1186/s40795-024-00907-0

The effect of different edible oils on body weight - BMC Nutrition In line with our findings, soybean oil, sunflower oil, and palm oil were associated with increased body weight, while sesame oil exhibited anti- ...

4. bestfoodfacts.org bestfoodfacts.org/soy-oil-obesity-study/

Is Soy Oil Making Us Fat? The results showed that the mice on the soybean oil-enriched diet gained almost 25 percent more weight than the mice on the coconut oil diet and nine percent ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0132672

Soybean Oil Is More Obesogenic and Diabetogenic than ... Our results indicate that in mice a diet high in soybean oil is more detrimental to metabolic health than a diet high in fructose or coconut oil.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2161831324001108

Review Health Effects of Various Edible Vegetable Oils This umbrella review aims to synthesize evidence from systematic reviews and meta-analyses to assess the health outcomes associated with various vegetable oils.

7. news.ucr.edu news.ucr.edu/articles/2023/07/03/widely-consumed-vegetable-oil-leads-unhealthy-gut

Widely consumed vegetable oil leads to an unhealthy gut High consumption of soybean oil has been linked to obesity and diabetes and potentially autism, Alzheimer's disease, anxiety, and depression.

8. nature.com nature.com/articles/s41598-017-12624-9

Omega-6 and omega-3 oxylipins are implicated in soybean ... Rich in unsaturated fats, especially linoleic acid, soybean oil is assumed to be healthy, and yet it induces obesity, diabetes, insulin ...