Clinical trial NCT05199948: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Nonalcoholic Fatty Liver
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 74
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Changes in ectopic liver lipids
timeFrame: Week 0 and Week 16
Secondary outcomes:
measure: Changes in visceral adipose tissue
timeFrame: Week 0 and Week 16
measure: Changes in postprandial lipids
timeFrame: Week 0 and Week 16
measure: Changes in postprandial markers of inflammation
timeFrame: Week 0 and Week 16
measure: Changes in postprandial energy metabolism
timeFrame: Week 0 and Week 16
Other outcomes:
measure: Association of changes in plasma linoleic acid with ectopic liver lipids, visceral adipose tissue, and postprandial lipids, markers of inflammation and energy metabolism
timeFrame: Week 0 and Week 16
measure: Changes in cardiolipin species
timeFrame: Week 0 and Week 16
measure: Changes in mitochondria function
timeFrame: Week 0 and Week 16
Locations:
city: Columbus
country: United States
facility: The Ohio State University Human Nutrition Laboratory
state: Ohio
Study officials:
References: