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OpenTrials
Active, Not Recruiting

NCT Number: NCT05199948

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

22 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University Human Nutrition Laboratory

Columbus, Ohio, 43210, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Soybean Oil Foods

Other

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

Other

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

Primary outcomes

  1. Changes in ectopic liver lipids

    Time frame: Week 0 and Week 16

    To determine the impact of dietary soybean oil on ectopic liver fat measured through MRI

Secondary outcomes

  1. Changes in visceral adipose tissue

    Time frame: Week 0 and Week 16

    To determine the impact of dietary soybean oil on visceral adipose tissue measured through MRI

  2. Changes in postprandial lipids

    Time frame: 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

  3. Changes in postprandial markers of inflammation

    Time frame: 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

  4. Changes in postprandial energy metabolism

    Time frame: Week 0 and Week 16

    To evaluate the effect of soybean oil supplementation on postprandial indirect calorimetry or respiratory gas exchange

Other outcomes

  1. Association of changes in plasma linoleic acid with ectopic liver lipids, visceral adipose tissue, and postprandial lipids, markers of inflammation and energy metabolism

    Time frame: Week 0 and Week 16

    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

  2. Changes in cardiolipin species

    Time frame: Week 0 and Week 16

    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

  3. Changes in mitochondria function

    Time frame: Week 0 and Week 16

    To determine the impact of dietary soybean oil on peripheral blood mononuclear cell mitochondria oxygen consumption rate using the seahorse assay

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jan 20, 2022
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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