Weight, Energy, Lipids, and the Liver (WELL) Study (NCT05199948) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Weight, Energy, Lipids, and the Liver (WELL) Study
United States74 participantsStarted 2022-05-02
Plain-language 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.
Who can participate
Age range22 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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