Weight, Energy, Lipids, and the Liver (WELL) Study

Study Overview
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Brief Summary
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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.

Detailed Description
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The study objectives include: 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 To evaluate the effect of soybean oil supplementation on postprandial lipids, markers of inflammation and energy metabolism To measure the strength of the association of change in plasma linoleic acid with changes in ectopic liver fat, visceral adipose, and postprandial lipids, markers of inflammation and energy metabolism To explore emerging mechanistic targets of LA-rich soybean oils that are linked with reduced liver fat and better cardiometabolic health

Official Title
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Weight, Energy, Lipids, and the Liver (WELL) Study: Dietary Fat Quality and Ectopic Lipids in the Liver

Conditions
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Nonalcoholic Fatty Liver

Intervention / Treatment
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* Other: Soybean Oil Foods
* Other: Palm Oil Foods


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nonalcoholic fatty liver disease (NAFLD), Nonalcoholic Steatohepatitis (NASH) or similar Body Mass Index of 20-55 kg/m2 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Soybean Oil<br>Consumption of study foods each day made with soybean oil | Other: Soybean Oil Foods<br>* Three food product containing 10g of soybean oil each will be consumed each day for a today of 30g of soybean oil consumed each day<br>|
| Placebo Comparator: Palm Oil<br>Consumption of study foods each day made with palm oil | Other: Palm Oil Foods<br>* Three food product containing 10g of palm oil each will be consumed each day for a today of 30g of palm oil consumed each day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in ectopic liver lipids | To determine the impact of dietary soybean oil on ectopic liver fat measured through MRI | Week 0 and Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in visceral adipose tissue | To determine the impact of dietary soybean oil on visceral adipose tissue measured through MRI | Week 0 and Week 16 | 
| Changes in postprandial lipids | To evaluate the effect of soybean oil supplementation on postprandial lipid panel including total cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglycerides | Week 0 and Week 16 | 
| Changes in postprandial markers of inflammation | To evaluate the effect of soybean oil supplementation on the postprandial IL-6, Tumor necrosis factor, and C-reactive protein in the blood | Week 0 and Week 16 | 
| Changes in postprandial energy metabolism | To evaluate the effect of soybean oil supplementation on postprandial indirect calorimetry or respiratory gas exchange | Week 0 and Week 16 |