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

Not Applicable

Active, not recruiting

• Conditions: Nonalcoholic Fatty Liver
• Interventions: Other: Soybean Oil Foods; Other: Palm Oil Foods

• Registration Number: NCT05199948
• Lead Sponsor: Ohio State University

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 inflammation and energy metabolism in participants who consume 3 study foods per day for 16 week, while maintaining their body weight.

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 Timeline

• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-01-19
• Study First Posted: 2022-01-20
• Study Start: 2022-05-02
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Primary Completion: 2025-05-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Soybean Oil	Soybean Oil Foods	Consumption of study foods each day made with soybean oil
Palm Oil	Palm Oil Foods	Consumption of study foods each day made with palm oil

Primary Outcome Measures

Name	Time	Method
Changes in ectopic liver lipids	Week 0 and Week 16	To determine the impact of dietary soybean oil on ectopic liver fat measured through MRI

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Ohio State University Human Nutrition Laboratory; 🇺🇸 Columbus, Ohio, United States