Nonalcoholic Fatty Liver
Conditions
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: 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
Interventions
OTHERSoybean 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
OTHERPalm 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
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed