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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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 0 and week 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 and week 16
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 moreOther 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
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Eligibility Criteria:
This trial includes the following eligibility 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.I have a liver condition not caused by alcohol.My heart condition has been stable, with no events or surgeries in the last 3 months.I don't have stomach or bowel problems that stop me from eating certain foods.I have an overactive thyroid.I have or had severe kidney, liver, or lung disease.I do not have severe circulatory or autoimmune diseases.I have been diagnosed with type 1 diabetes.I haven't taken Vitamin E, Actos, or GLP-1 meds for more than a month.
Research Study Groups:
This trial has the following groups:- Group 1: Soybean Oil
- Group 2: Palm Oil
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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