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Dietary Oils for Fatty Liver Disease
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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 and week 16
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in ectopic liver lipids
Secondary outcome measures
Changes in postprandial energy metabolism
Changes in postprandial lipids
Changes in postprandial markers of inflammation
+1 moreOther outcome measures
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
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Who is running the clinical trial?
Ohio State UniversityLead Sponsor
827 Previous Clinical Trials
502,677 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
21 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the qualifications for joining this experiment?
"This clinical trial is looking for 74 individuals aged 25-80 who have been diagnosed with Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH) or a similar illness, must be nonsmokers and should possess a Body Mass Index of between 25-55 kg/m2."
Answered by AI
Are there any open slots for individuals seeking to participate in this research?
"The data hosted on clinicaltrials.gov suggests that this medical study is recruiting participants at the time of writing. It was initially posted on May 2nd 2022 and the most recent update occurred September 19th, 2022."
Answered by AI
Is the prerequisite age of eligibility for this medical study greater than twenty years?
"This clinical trial is available to patients aged 25 to 80. Those below 18 or above 65 may wish to consult the 22 trials for minors and 192 studies for elderly individuals respectively."
Answered by AI
How many participants are part of this clinical trial?
"Affirmative. Information found on clinicaltrials.gov reveals that the enrollment process for this trial is still ongoing, with its initial posting being recorded as May 2nd 2022 and most recent edits taking place September 19th 2022. A total of 74 participants are needed from a single medical centre."
Answered by AI
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