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

NCT ID: NCT05199948

Last Updated: 2025-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-02

Study Completion Date

2026-02-01

Brief Summary

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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

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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

Conditions

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Nonalcoholic Fatty Liver

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Soybean Oil

Consumption of study foods each day made with soybean oil

Group Type EXPERIMENTAL

Soybean Oil Foods

Intervention Type 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

Consumption of study foods each day made with palm oil

Group Type PLACEBO_COMPARATOR

Palm Oil Foods

Intervention Type 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

Interventions

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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

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Martha Belury

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Ohio State University Human Nutrition Laboratory

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2021H0290

Identifier Type: -

Identifier Source: org_study_id

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