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

Nonalcoholic Fatty Liver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05199948
• Other study ID #: 2021H0290
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2, 2022
• Est. completion date: February 1, 2025

Study information

• Verified date: March 2024
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 74
• Est. completion date: February 1, 2025
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver

Intervention

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
• 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

Locations

Country	Name	City	State
United States	The Ohio State University Human Nutrition Laboratory	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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