Dietary Oils for Fatty Liver Disease

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RC
Overseen ByRachel Cole, PhD, RDN

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of dietary oils to assess their effects on liver health and metabolism in individuals with fatty liver disease. Over 16 weeks, participants will consume foods made with either soybean oil or palm oil to measure changes in liver fat, body fat, and other health markers. It suits those with nonalcoholic fatty liver disease who experience issues like weight gain or fatigue. As an unphased trial, this study provides a unique opportunity for participants to contribute to understanding dietary impacts on liver 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 you cannot use Vitamin E supplements, Actos, or certain diabetes medications less than a month before enrolling. Also, if your medications conflict with the study foods, you may not be eligible.

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

Research shows that soybean oil can have both positive and negative effects on the liver. Some studies suggest it may reduce liver fat and improve liver function in individuals with fatty liver disease, potentially benefiting heart health as well. However, other research indicates that soybean oil might worsen liver damage if the liver is already compromised.

Palm oil often serves as a comparison in studies. While generally safe to consume, it does not offer the same potential liver benefits as soybean oil.

Overall, both oils are commonly used in foods and are considered safe in normal amounts. However, their effects on liver health can vary based on a person's health and diet.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for fatty liver disease because they explore the impact of dietary oils, specifically soybean and palm oil, on liver health. Unlike conventional treatments that might focus on medications to reduce liver fat or lifestyle changes like diet and exercise, this approach examines the direct effects of specific dietary fats. Palm oil serves as a placebo comparator, while soybean oil is being tested for its potential benefits. This could lead to a more natural and accessible dietary intervention for managing fatty liver disease.

What evidence suggests that this trial's treatments could be effective for fatty liver disease?

This trial will compare the effects of foods made with soybean oil to those made with palm oil on fatty liver disease. Research suggests that foods containing soybean oil might aid in managing fatty liver disease. Studies have shown that soybean oil, rich in healthy fats, can be part of a diet that improves liver health. Some evidence indicates that soybean oil can even help prevent or reduce liver fat in conditions like non-alcoholic fatty liver disease (NAFLD). As a key component of the Mediterranean diet, soybean oil is associated with liver health benefits. However, one study found that in certain diets, soybean oil might worsen liver damage, so results can vary. Overall, foods with soybean oil have shown promise for liver health, but more research is needed to fully understand their effects.23467

Are You a Good Fit for This Trial?

The WELL Study is for adults with Nonalcoholic Fatty Liver Disease (NAFLD) or similar conditions, who are nonsmokers with a BMI of 25-55 kg/m2. It's not for those with heart issues, pregnant or breastfeeding women, people unable to undergo venipuncture, those on certain diets or medications that conflict with the study foods, and individuals with specific gastrointestinal diseases, kidney failure, some liver and pulmonary diseases.

Inclusion Criteria

I have a liver condition not caused by alcohol.
Body Mass Index of 20-55 kg/m2

Exclusion Criteria

I cannot have blood drawn because my veins are hard to access.
I am not on medications that restrict my diet.
I am currently being treated for a cancer that is not non-melanoma skin cancer.
See 14 more

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 per day for 16 weeks, with either soybean oil or palm oil, while maintaining their body weight

16 weeks
Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Palm Oil Foods
  • Soybean Oil Foods
Trial Overview This trial tests how daily consumption of foods made with soybean oil versus palm oil affects liver fat accumulation and other health markers over 16 weeks. Participants will be randomly assigned to one of these two dietary interventions while keeping their body weight stable.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Soybean OilExperimental Treatment1 Intervention
Group II: Palm OilPlacebo Group1 Intervention

Find a Clinic Near You

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

Citations

Soybean Oil-Derived Poly-Unsaturated Fatty Acids Enhance ...Soybean oil-derived poly-unsaturated fatty acids enhance liver damage in NAFLD induced by dietary cholesterol.
Preclinical and clinical evidence for the treatment of non- ...Soybeans are the main component of the Mediterranean diet and are considered an effective treatment for non-alcoholic fatty liver disease.
Effects of Different Vegetable Oils on the Nonalcoholic Fatty ...In conclusion, the commercial vegetable oils either contributed to the prevention or reduction of induced nonalcoholic fatty liver with high fat ...
Protective Effect of Soybean Bioactive Compounds on ...Epidemiological data have shown the beneficial effects of soy-containing diets on patients with liver disorders represented by nonalcoholic ...
A Lard and Soybean Oil Mixture Alleviates Low-Fat–High- ...Our results showed that mixed oil significantly inhibited serum triglyceride, liver triglyceride, serum free fatty acids (FFAs), and liver FFAs compared with ...
The Effects of Dietary Soybean Oil on Liver Fat and ...Reducing liver fat and visceral adipose tissue through consumption of a LA-rich soybean oil may ultimately lead to improved cardiometabolic outcomes for adults ...
Effect of dietary soybean oil inclusion on liver-related ...These findings demonstrated that key TF related to lipid metabolism could be modulated by dietary inclusion of soybean oil.
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