Weight, Energy, Lipids, and the Liver (WELL) Study
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
The study objectives include:
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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
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To evaluate the effect of soybean oil supplementation on postprandial lipids, markers of inflammation and energy metabolism
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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
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To explore emerging mechanistic targets of LA-rich soybean oils that are linked with reduced liver fat and better cardiometabolic health
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Soybean Oil Consumption of study foods each day made with soybean oil |
Other: 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
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Placebo Comparator: Palm Oil Consumption of study foods each day made with palm oil |
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
|
Outcome Measures
Primary Outcome Measures
- Changes in ectopic liver lipids [Week 0 and Week 16]
To determine the impact of dietary soybean oil on ectopic liver fat measured through MRI
Secondary Outcome Measures
- Changes in visceral adipose tissue [Week 0 and Week 16]
To determine the impact of dietary soybean oil on visceral adipose tissue measured through MRI
- Changes in postprandial lipids [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
- Changes in postprandial markers of inflammation [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
- Changes in postprandial energy metabolism [Week 0 and Week 16]
To evaluate the effect of soybean oil supplementation on postprandial indirect calorimetry or respiratory gas exchange
Other Outcome Measures
- 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]
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
- Changes in cardiolipin species [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
- Changes in mitochondria function [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Nonalcoholic fatty liver disease (NAFLD), Nonalcoholic Steatohepatitis (NASH) or similar diagnosis
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Nonsmokers
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Body Mass Index of 25-55 kg/m2
Exclusion Criteria:
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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
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Current or previous diagnosis of kidney failure or diseases, some liver and pulmonary diseases
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Current or previous diagnosis of some circulatory diseases and autoimmune diseases
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Current diagnosis of or current treatment of cancer other than non-melanoma skin cancer
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Current or previous diagnosis of type 1 diabetes
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Use of Vitamin E supplements or Actos and Glucagon-like Peptide-1 medications for less than 6 months prior to enrolling.
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Gastrointestinal diseases or disorders (including pancreatic and gastric bypass surgery) that would prevent participants from tolerating the study foods
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Food Allergy or intolerances
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Any dietary restriction where consumption of the study foods, study meals/snack or meal challenge or any ingredient would be contraindicated
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Use of medications where consuming the food products would be contraindicated
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Current use of supplements or medications for weight loss or following a weight loss program
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Use of supplements high in linoleic acid in the past 4 weeks prior to enrolling
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Pregnancy and lactation
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Alcohol or drug abuse
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Inability to access veins for venipuncture
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Claustrophobia
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Metal implants or metallic foreign objects in the body
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | The Ohio State University Human Nutrition Laboratory | Columbus | Ohio | United States | 43210 |
Sponsors and Collaborators
- Ohio State University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021H0290