Back to resultsWeight, Energy, Lipids, and the Liver (WELL) Study
Primary Purpose
Nonalcoholic Fatty Liver
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Soybean Oil Foods
Palm Oil Foods
Sponsored by
About this trial
This is an interventional treatment trial for Nonalcoholic Fatty Liver
Eligibility Criteria
Inclusion Criteria:
- Nonalcoholic fatty liver disease (NAFLD), Nonalcoholic Steatohepatitis (NASH) or similar diagnosis
- Nonsmokers
- Body Mass Index of 25-55 kg/m2
Exclusion Criteria:
- Current or previous diagnosis of heart failure, heart disease events, a need for heart surgeries or procedures, and/or the use of a pacemaker or defibrillator
- Current or previous diagnosis of kidney failure or diseases, some liver and pulmonary diseases
- Current or previous diagnosis of some 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 6 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
- Current use of supplements or medications for weight loss or following a weight loss program
- Use of supplements high in linoleic acid in the past 4 weeks prior to enrolling
- Pregnancy and lactation
- Alcohol or drug abuse
- Inability to access veins for venipuncture
- Claustrophobia
- Metal implants or metallic foreign objects in the body
Sites / Locations
- The Ohio State University Human Nutrition Laboratory
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Soybean Oil
Palm Oil
Arm Description
Consumption of study foods each day made with soybean oil
Consumption of study foods each day made with palm oil
Outcomes
Primary Outcome Measures
Changes in ectopic liver lipids
To determine the impact of dietary soybean oil on ectopic liver fat measured through MRI
Secondary Outcome Measures
Changes in visceral adipose tissue
To determine the impact of dietary soybean oil on visceral adipose tissue measured through MRI
Changes in postprandial lipids
To evaluate the effect of soybean oil supplementation on postprandial lipid panel including total cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglycerides
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
Changes in postprandial energy metabolism
To evaluate the effect of soybean oil supplementation on postprandial indirect calorimetry or respiratory gas exchange
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05199948
Brief Title
Weight, Energy, Lipids, and the Liver (WELL) Study
Official Title
Weight, Energy, Lipids, and the Liver (WELL) Study: Dietary Fat Quality and Ectopic Lipids in the Liver
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 2, 2022 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Fatty Liver
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Soybean Oil
Arm Type
Experimental
Arm Description
Consumption of study foods each day made with soybean oil
Arm Title
Palm Oil
Arm Type
Placebo Comparator
Arm Description
Consumption of study foods each day made with palm oil
Intervention Type
Other
Intervention Name(s)
Soybean Oil Foods
Intervention Description
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
Intervention Name(s)
Palm Oil Foods
Intervention Description
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 Outcome Measure Information:
Title
Changes in ectopic liver lipids
Description
To determine the impact of dietary soybean oil on ectopic liver fat measured through MRI
Time Frame
Week 0 and Week 16
Secondary Outcome Measure Information:
Title
Changes in visceral adipose tissue
Description
To determine the impact of dietary soybean oil on visceral adipose tissue measured through MRI
Time Frame
Week 0 and Week 16
Title
Changes in postprandial lipids
Description
To evaluate the effect of soybean oil supplementation on postprandial lipid panel including total cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglycerides
Time Frame
Week 0 and Week 16
Title
Changes in postprandial markers of inflammation
Description
To evaluate the effect of soybean oil supplementation on the postprandial IL-6, Tumor necrosis factor, and C-reactive protein in the blood
Time Frame
Week 0 and Week 16
Title
Changes in postprandial energy metabolism
Description
To evaluate the effect of soybean oil supplementation on postprandial indirect calorimetry or respiratory gas exchange
Time Frame
Week 0 and Week 16
Other Pre-specified Outcome Measures:
Title
Association of changes in plasma linoleic acid with ectopic liver lipids, visceral adipose tissue, and postprandial lipids, markers of inflammation and energy metabolism
Description
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
Time Frame
Week 0 and Week 16
Title
Changes in cardiolipin species
Description
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
Time Frame
Week 0 and Week 16
Title
Changes in mitochondria function
Description
To determine the impact of dietary soybean oil on peripheral blood mononuclear cell mitochondria oxygen consumption rate using the seahorse assay
Time Frame
Week 0 and Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The Ohio State University Human Nutrition Laboratory
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Weight, Energy, Lipids, and the Liver (WELL) Study
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