Dietary Oils for Fatty Liver Disease

Overseen By Rachel Cole, PhD, RDN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Must not be taking: Vitamin E, Actos, GLP-1, others

Disqualifiers: Heart disease, Kidney failure, Cancer, Diabetes, others

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

74 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Palm Oil Foods, Soybean Oil Foods for fatty liver disease?

Research suggests that adding soybean oil to a diet can help reduce early signs of liver damage and glucose intolerance in mice, which are related to fatty liver disease. Additionally, a blend of lard and soybean oil improved liver function markers in humans, indicating potential benefits for liver health. ^{1 2 3 4 5}

Is it safe to consume palm oil and soybean oil for liver health?

Palm oil and soybean oil have been studied for their effects on liver health. Palm oil, especially when oxidized, may pose risks to liver health, while moderate consumption of red or refined palm oil might be safer. Soybean oil, when mixed with lard, showed benefits for liver function markers in healthy people. ^{2 5 6 7 8}

How does the treatment with palm oil and soybean oil foods differ from other treatments for fatty liver disease?

This treatment is unique because it involves dietary modification using palm oil and soybean oil foods, which may influence liver health differently compared to other treatments. Palm oil is known to affect liver fat and metabolism, while soybean oil has been shown to improve liver function markers in some studies, potentially offering a novel dietary approach to managing fatty liver disease. ^{1 2 5 9 10}

What is the purpose of this trial?

The research study is a parallel arm, randomized placebo-controlled clinical trial designed to assess changes in hepatic lipid accumulation, visceral adipose tissue and postprandial lipid, markers of inflammation and energy metabolism in participants who consume 3 study foods per day for 16 week, while maintaining their body weight.

Eligibility Criteria

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.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Fortifying Butterfat with Soybean Oil Attenuates the Onset of Diet-Induced Non-Alcoholic Steatohepatitis and Glucose Intolerance. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Olive Oil, Palm Oil, and Hybrid Palm Oil Distinctly Modulate Liver Transcriptome and Induce NAFLD in Mice Fed a High-Fat Diet. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Untargeted metabolomics characteristics of nonobese nonalcoholic fatty liver disease induced by high-temperature-processed feed in Sprague-Dawley rats. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Intake of n-3 polyunsaturated fatty acids and non-alcoholic fatty liver disease: a cross-sectional study in Japanese men and women. [2016]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Lard or Plus Soybean Oil on Markers of Liver Function in Healthy Subjects: A Randomized Controlled-Feeding Trial. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Fat: Quality, or Quantity? What Matters Most for the Progression of Metabolic Associated Fatty Liver Disease (MAFLD). [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

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

8. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of palm and mixtures of refined palm and soybean oils on serum lipids and fecal fat and fatty acid excretions of adult humans. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Alpha-tocopherol in intravenous lipid emulsions imparts hepatic protection in a murine model of hepatosteatosis induced by the enteral administration of a parenteral nutrition solution. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Dietary modulation of fatty acid profiles and oxidative status of rat hepatocyte nodules: effect of different n-6/n-3 fatty acid ratios. [2019]