Status:
ACTIVE_NOT_RECRUITING
Weight, Energy, Lipids, and the Liver (WELL) Study
Lead Sponsor:
Ohio State University
Conditions:
Nonalcoholic Fatty Liver
Eligibility:
All Genders
22-80 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
The study objectives include: 1. To determine the impact of dietary soybean oil on ectopic liver fat and visceral adipose in adults with nonalcoholic fatty liver disease (NAFLD) or similar diagnosis ...
Eligibility Criteria
Inclusion
- Nonalcoholic fatty liver disease (NAFLD), Nonalcoholic Steatohepatitis (NASH) or similar
- Body Mass Index of 20-55 kg/m2
Exclusion
- Unstable management of heart failure, heart disease events within 3 months, a need for heart surgeries or procedures, and/or the use of a pacemaker or defibrillator
- Current or previous diagnosis of severe kidney failure or diseases, some liver and pulmonary diseases
- Severe or uncontrolled circulatory diseases and autoimmune diseases
- Current diagnosis of or current treatment of cancer other than non-melanoma skin cancer
- Current or previous diagnosis of type 1 diabetes
- Use of Vitamin E supplements or Actos and Glucagon-like Peptide-1 medications for less than 1 months prior to enrolling.
- Gastrointestinal diseases or disorders (including pancreatic and gastric bypass surgery) that would prevent participants from tolerating the study foods
- Food Allergy or intolerances
- Any dietary restriction where consumption of the study foods, study meals/snack or meal challenge or any ingredient would be contraindicated
- Use of medications where consuming the food products would be contraindicated
- Use of supplements high in linoleic acid in the past 4 weeks prior to enrolling
- Hyperthyroidism
- Pregnancy and lactation
- Alcohol or drug abuse
- Inability to access veins for venipuncture
- Claustrophobia
- Metal implants or metallic foreign objects in the body
Key Trial Info
Start Date :
May 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT05199948
Start Date
May 2 2022
End Date
February 1 2026
Last Update
December 9 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Ohio State University Human Nutrition Laboratory
Columbus, Ohio, United States, 43210