Nonalcoholic Fatty LiverNCT05199948
Weight, Energy, Lipids, and the Liver (WELL) Study
A study testing Soybean Oil Foods and Palm Oil Foods in people with Nonalcoholic Fatty Liver, run by Ohio State University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Nonalcoholic Fatty Liver
- What is being tested?
- Soybean Oil Foods and Palm Oil Foods
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2022to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nonalcoholic fatty liver disease (NAFLD), Nonalcoholic Steatohepatitis (NASH) or similar
- Body Mass Index of 20-55 kg/m2
Who cannot join
- 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.
Show all 17Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Human Nutrition Laboratory
Columbus, Ohio, 43210
About this study
Official title: Weight, Energy, Lipids, and the Liver (WELL) Study: Dietary Fat Quality and Ectopic Lipids in the Liver
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.
Read the detailed description
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
- Conditions
- Nonalcoholic Fatty Liver
- Being tested
- Soybean Oil Foods, Palm Oil Foods
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soybean Oil FoodsOther
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 FoodsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Soybean Oil | Experimental | Consumption of study foods each day made with soybean oil Receives: Other: Soybean Oil Foods |
| Palm Oil | Placebo comparator | Consumption of study foods each day made with palm oil Receives: Other: Palm Oil Foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in ectopic liver lipids
To determine the impact of dietary soybean oil on ectopic liver fat measured through MRI
Measured: Week 0 and Week 16
Secondary outcomes (4)
Changes in visceral adipose tissue
To determine the impact of dietary soybean oil on visceral adipose tissue measured through MRI
Measured: Week 0 and Week 16
Changes in postprandial lipids
To evaluate the effect of soybean oil supplementation on postprandial lipid panel including total cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglycerides
Measured: Week 0 and Week 16
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
Measured: Week 0 and Week 16
Changes in postprandial energy metabolism
To evaluate the effect of soybean oil supplementation on postprandial indirect calorimetry or respiratory gas exchange
Measured: Week 0 and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start2 May 2022
- Primary completion1 Sep 2025
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nonalcoholic Fatty LiverStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martha Belury, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199948
- Sponsor's protocol ID
- 2021H0290
- Status last verified
- Apr 2026
- First submitted
- 5 Jan 2022
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Belury MA, Cole RM, Ni A, Kolipaka A, Nanjappa M, Thompson K, Kalhori A, Zarich S, Choriego RE, Jimenez-Flores R, Li N. Dietary Soybean vs. Palm Oils Differ in Effects on Liver Fat in Adults With MAFLD: A 16-Week, Double-Masked, Randomized Controlled Trial. Diabetes Obes Metab. 2026 Sep 1. doi: 10.1111/dom.71237. Online ahead of print.
PubMed 42677730Kalhori A, Cole RM, Zarich S, Li N, Kolipaka A, Ni A, Sparagna GC, Belury MA. Plasma linoleic acid is related to lower hepatic steatosis index and higher linoleate-rich cardiolipin in adults with MAFLD. Am J Physiol Gastrointest Liver Physiol. 2026 Apr 1;330(4):G478-G486. doi: 10.1152/ajpgi.00344.2025. Epub 2026 Mar 11.
PubMed 41811730
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight, Energy, Lipids, and the Liver (WELL) Study: Dietary Fat Quality and Ectopic Lipids in the Liver
- ClinicalTrials.gov ID
- NCT05199948
- Acronym / sponsor ID
- 2021H0290
- Conditions
- Nonalcoholic Fatty Liver
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soybean Oil | Experimental | Other: Soybean Oil FoodsConsumption of study foods each day made with soybean oil |
| Palm Oil | Placebo comparator | Other: Palm Oil FoodsConsumption of study foods each day made with palm oil |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Nonalcoholic fatty liver disease (NAFLD), Nonalcoholic Steatohepatitis (NASH) or similar
- Body Mass Index of 20-55 kg/m2
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soybean Oil FoodsThree food product containing 10g of soybean oil each will be consumed each day for a today of 30g of soybean oil consumed each day | Other | Soybean Oil |
| Palm Oil FoodsThree food product containing 10g of palm oil each will be consumed each day for a today of 30g of palm oil consumed each day | Other | Palm Oil |
Primary outcome
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
4 secondary outcomes
Changes in visceral adipose tissue
Time frame: Week 0 and Week 16
Changes in postprandial lipids
Time frame: Week 0 and Week 16
Changes in postprandial markers of inflammation
Time frame: Week 0 and Week 16
Changes in postprandial energy metabolism
Time frame: Week 0 and Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Derived from this study: PubMed 42677730Belury MA, Cole RM, Ni A, Kolipaka A, Nanjappa M, Thompson K, Kalhori A, Zarich S, Choriego RE, Jimenez-Flores R, Li N. Dietary Soybean vs. Palm Oils Differ in Effects on Liver Fat in Adults With MAFLD: A 16-Week, Double-Masked, Randomized Controlled Trial. Diabetes Obes Metab. 2026 Sep 1. doi: 10.1111/dom.71237. Online ahead of print.
- Derived from this study: PubMed 41811730Kalhori A, Cole RM, Zarich S, Li N, Kolipaka A, Ni A, Sparagna GC, Belury MA. Plasma linoleic acid is related to lower hepatic steatosis index and higher linoleate-rich cardiolipin in adults with MAFLD. Am J Physiol Gastrointest Liver Physiol. 2026 Apr 1;330(4):G478-G486. doi: 10.1152/ajpgi.00344.2025. Epub 2026 Mar 11.
Related trials for Nonalcoholic Fatty Liver
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soybean Oil Foods and Palm Oil Foods in people with Nonalcoholic Fatty Liver, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in ectopic liver lipids (time frame: Week 0 and Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05199948, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.