Weight, Energy, Lipids, and the Liver (WELL) Study

Sponsor
Ohio State University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05199948
Collaborator
(none)
74
1
2
33.3
2.2

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
  • Other: Soybean Oil Foods
  • Other: Palm Oil Foods
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Weight, Energy, Lipids, and the Liver (WELL) Study: Dietary Fat Quality and Ectopic Lipids in the Liver
Anticipated Study Start Date :
Apr 25, 2022
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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

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

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

  1. 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

  2. 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

  3. 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

Ages Eligible for Study:
25 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
Martha Belury, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier:
NCT05199948
Other Study ID Numbers:
  • 2021H0290
First Posted:
Jan 20, 2022
Last Update Posted:
Apr 19, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 19, 2022