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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Nonalcoholic Fatty Liver
• Intervention / Treatment: Other: Soybean Oil Foods; Other: Palm Oil Foods

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
2. To evaluate the effect of soybean oil supplementation on postprandial lipids, markers of inflammation and energy metabolism
3. 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
4. To explore emerging mechanistic targets of LA-rich soybean oils that are linked with reduced liver fat and better cardiometabolic health

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Human Nutrition Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Soybean Oil; Consumption of study foods each day made with soybean oil	Other: Soybean Oil Foods; 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
Placebo Comparator: Palm Oil; Consumption of study foods each day made with palm oil	Other: Palm Oil Foods; 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association of changes in plasma linoleic acid with ectopic liver lipids, visceral adipose tissue, and postprandial lipids, markers of inflammation and energy metabolism	Use multiple linear regressions to determine the association of change in plasma linoleic acid with changes in ectopic liver fat, visceral adipose, and postprandial total cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglycerides, L-6, Tumor necrosis factor, and C-reactive protein and indirect calorimetry	Week 0 and Week 16
Changes in cardiolipin species	To determine the impact of dietary soybean oil on peripheral blood mononuclear cell cardiolipin species measured using electrospray ionization-mass spectrometry coupled to high-performance liquid chromatography	Week 0 and Week 16
Changes in mitochondria function	To determine the impact of dietary soybean oil on peripheral blood mononuclear cell mitochondria oxygen consumption rate using the seahorse assay	Week 0 and Week 16

Collaborators and Investigators

• Sponsor: Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Actual): September 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 5, 2022
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 2021H0290

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No