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

The Ohio State University

Status: Active, not recruiting

Conditions: Nonalcoholic Fatty Liver

Treatments: Other: Soybean Oil Foods; Other: Palm Oil Foods

Study type: Interventional

Funder types: Other

Identifiers

NCT05199948

2021H0290

Details and patient eligibility

About

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.

Full 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

Enrollment: 74 estimated patients

Sex: All

Ages: 22 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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74 participants in 2 patient groups, including a placebo group

Soybean Oil

Experimental group

Description:

Consumption of study foods each day made with soybean oil

Treatment:

Other: Soybean Oil Foods

Palm Oil

Placebo Comparator group

Description:

Consumption of study foods each day made with palm oil

Treatment:

Other: Palm Oil Foods