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Dietary Oils for Fatty Liver Disease

N/A
Waitlist Available
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Nonalcoholic fatty liver disease (NAFLD), Nonalcoholic Steatohepatitis (NASH) or similar
Be older than 18 years old
Must not have
Inability to access veins for venipuncture
Use of medications where consuming the food products would be contraindicated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 and week 16

Summary

This trial is testing whether 3 different foods can help reduce fat in the liver, visceral fat, and increase energy metabolism.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include digestive discomfort due to changes in diet composition. Since this involves common food oils (soybean and palm), allergic reactions could occur in rare cases among sensitive individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a liver condition not caused by alcohol.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot have blood drawn because my veins are hard to access.
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I am not on medications that restrict my diet.
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I am currently being treated for a cancer that is not non-melanoma skin cancer.
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My heart condition has been stable, with no events or surgeries in the last 3 months.
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I don't have stomach or bowel problems that stop me from eating certain foods.
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I have an overactive thyroid.
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I do not have severe circulatory or autoimmune diseases.
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I have been diagnosed with type 1 diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 and week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 and week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in ectopic liver lipids
Secondary study objectives
Changes in postprandial energy metabolism
Changes in postprandial lipids
Changes in postprandial markers of inflammation
+1 more
Other study objectives
Association of changes in plasma linoleic acid with ectopic liver lipids, visceral adipose tissue, and postprandial lipids, markers of inflammation and energy metabolism
Changes in cardiolipin species
Changes in mitochondria function

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Soybean OilExperimental Treatment1 Intervention
Consumption of study foods each day made with soybean oil
Group II: Palm OilPlacebo Group1 Intervention
Consumption of study foods each day made with palm oil

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
866 Previous Clinical Trials
655,050 Total Patients Enrolled

Media Library

Palm Oil Foods (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05199948 — N/A
Fatty Liver Disease Research Study Groups: Soybean Oil, Palm Oil
Fatty Liver Disease Clinical Trial 2023: Palm Oil Foods Highlights & Side Effects. Trial Name: NCT05199948 — N/A
Palm Oil Foods (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05199948 — N/A
~0 spots leftby Dec 2024