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

NCT05199948 | Active Not Recruiting

• 1 other identifier: 2021H0290
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonalcoholic Fatty Liver

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Changes in visceral adipose tissue

  Week 0 and Week 16

• Changes in postprandial lipids

  Week 0 and Week 16

• Changes in postprandial markers of inflammation

  Week 0 and Week 16

• Changes in postprandial energy metabolism

  Week 0 and Week 16

Other Outcomes (3)

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

  Week 0 and Week 16

• Changes in cardiolipin species

  Week 0 and Week 16

• Changes in mitochondria function

  Week 0 and Week 16

Study Arms (2)

Soybean Oil

EXPERIMENTAL

Consumption of study foods each day made with soybean oil

Other: Soybean Oil Foods

Palm Oil

PLACEBO COMPARATOR

Consumption of study foods each day made with palm oil

Other: Palm Oil Foods

Interventions

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

Soybean Oil

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

Palm Oil

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nonalcoholic fatty liver disease (NAFLD), Nonalcoholic Steatohepatitis (NASH) or similar
• Body Mass Index of 20-55 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Human Nutrition Laboratory

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 20, 2022
• Study Start: May 2, 2022
• Primary Completion: September 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (1)