Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
NCT ID:
NCT03784716
Eligibility Criteria:
Inclusion Criteria:
* Age greater than or equal to 18 years at enrollment
* Diagnosis of NAFLD verified by screening MRI-PDFF greater than or equal to 8%
* Women able to become pregnant must have a confirmed negative pregnancy test result prior to enrollment because MRI is contraindicated in pregnant women. Women ≥ 50 years of age who have not had a menstrual period in the past year; and women who have had a hysterectomy, both ovaries removed, or a tubal ligation; will not be required to have a pregnancy test.
* Women able to become pregnant must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
* Ability to understand and the willingness to sign a written informed consent document and medical release
* Willing and able to comply with trial protocol and follow-up
Exclusion Criteria:
* Prior diagnosis of chronic liver disease other than NAFLD, including autoimmune, viral, and alcoholic liver disease
* Prior diagnosis of liver cirrhosis as defined by any of the following criteria:
* Cirrhosis on historical liver biopsy; or
* Evidence of cirrhosis on liver imaging (CT, MRI, or US) including a nodular liver surface, splenomegaly, or portal venous collaterals; or
* Prior history of decompensated liver disease, including ascites, hepatic encephalopathy, or variceal bleeding; or
* FibroScan value of \>14.9 kPa; or
* MRE of 4.67 kPa or higher
* History of liver transplantation
* Body mass index (BMI) less than 27 kg/m
* Unstable body weight (\> 10% change in prior 3 months)
* Prior weight reduction surgery within the last 5 years
* Use of a medication prescribed for weight loss within the past 3 months
* Current alcohol consumption \>21 oz. per week for males or \>14 oz. per week for females (1 oz./30 mL of alcohol is present in one 12 oz./360 mL beer, one 4 oz./120 mL glass of wine, and one 1 oz./30 mL measure of 40% proof alcohol)
* Unstable cardiovascular disease as defined by any of the following:
* Unstable angina within 6 months prior to screening
* Myocardial infarction, coronary artery bypass graft surgery or coronary angioplasty within 6 months prior to screening
* Transient ischemic attack or cerebrovascular accident within 6 months prior to screening
* Obstructive valvular heart disease or hypertrophic cardiomyopathy
* Unstable congestive heart failure
* Women who are pregnant or breastfeeding or are implanted with intrauterine devices that are not MRI-compatible
* Active malignancy within the past 5 years (excluding basal/squamous cell skin cancer, or prostate cancer with a Gleason score 6 or less)
* Known HIV infection
* Food allergies or dietary restrictions, including vegan or vegetarian diet, which cannot be accommodated with the prepared meal service
* Contraindication to undergo MRI-PDFF or MRE, including persons with mechanically, magnetically, or electrically activated implants, such as cardiac pacemakers or defibrillators, or infusion pumps; or ferromagnetic implants or foreign bodies, such as aneurysm clips or shrapnel; or other implanted electronic devices or metallic parts in the body prohibiting MRI. Because the MRI scanner is also used with animals, persons with allergy to animal dander or animal-instigated asthma are also excluded.
* Resides outside of the meal delivery zone or plans to travel outside of the meal delivery zone for more than one day while on the study intervention and will be unable to access the meal delivery
* Current use of any investigational agents
* Concurrent illness or abnormal laboratory result which in the opinion of the investigators would compromise either the patient or the integrity of the data
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03784716
Study Brief:
Protocol Section:
NCT03784716