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NCT05199948Active, not recruiting

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

Weight, Energy, Lipids, and the Liver (WELL) Study: Dietary Fat Quality and Ectopic Lipids in the Liver

Source: ClinicalTrials.gov · Last updated 21 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
74 (estimated)
First submitted
5 Jan 2022
Start date
2 May 2022
Primary completion date
1 Sept 2025
Lead sponsor
Ohio State University
NCT number
NCT05199948

What you commit to

  • Study type: Interventional
  • Planned participants: 74
  • From 2 May 2022 to the primary completion date, 1 Sept 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current or previous diagnosis of severe kidney failure or diseases, some liver and pulmonary diseases
  • 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.
  • 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
  • Alcohol or drug abuse
  • Metal implants or metallic foreign objects in the body

Other illness

  • 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
  • Severe or uncontrolled circulatory diseases and autoimmune diseases
  • Current diagnosis of or current treatment of cancer other than non-melanoma skin cancer
  • Gastrointestinal diseases or disorders (including pancreatic and gastric bypass surgery) that would prevent participants from tolerating the study foods
  • Food Allergy or intolerances

Other

  • Any dietary restriction where consumption of the study foods, study meals/snack or meal challenge or any ingredient would be contraindicated
  • Hyperthyroidism
  • Pregnancy and lactation
  • Inability to access veins for venipuncture
  • Claustrophobia

Who the study is looking for

  • Nonalcoholic fatty liver disease (NAFLD), Nonalcoholic Steatohepatitis (NASH) or similar
  • Body Mass Index of 20-55 kg/m2

Age in the registry: 22 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Ohio State University Human Nutrition Laboratory
Coordinator of this site? Confirm its status
ColumbusUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.