NCT04861571Active, not recruiting
Effect of VLCD on the Reduction of Liver Steatosis and Fibrosis in Subjects With Obesity and NAFLD
Effect of Very Low-calorie Diet on the Reduction of Liver Steatosis and Fibrosis in Subjects With Obesity and Non-alcoholic Fatty Liver Disease
Source: ClinicalTrials.gov · Last updated 10 Mar 2026
Brief summary (registry, in English)
Non-alcoholic fatty liver disease (NAFLD) is a common complication of obesity which can progress to deadly complications like end-stage liver disease and hepatocellular carcinoma. In the wake of the obesity epidemic, NAFLD is becoming the main etiology of liver transplantation in the US. Currently, there are no FDA approved pharmacological treatments for NAFLD. Weight loss through lifestyle modifications, pharmacotherapy and bariatric surgery can be effective strategies for the management of NAFLD. Even though substantial weight loss and improvement in NAFLD can be achieved with bariatric surgery, only a small proportion of patients with obesity undergo surgery. Very-low calorie diets (VLCD) are replacement meals manufactured to substitute natural foods and limited total intake of 800-960 kcal in divided meals. Very low-calorie diets can produce substantial weight loss of 10% over 2 to 3 months. We hypothesize that VLCD reduce liver steatosis and, fibrosis measured non-invasively with transient elastography. Our main aim is #1 to assess the effect of VLCD on liver fatty infiltration and fibrosis. We also have three exploratory aims exploring novel pathogenic factors that mediate the improvement of NAFLD by VLCD: #2 assess the effect of VLCD on micro RNAs (miRs) associated with pathophysiology of NAFLD: #3 assess the effect of VLCD on changes of salivary and fecal microbiome in the setting of NAFLD: #4 to determine the effect of VLCD on platelet function. This pilot project will produce preliminary data for the development of a larger grant application to study the efficacy of VLCD in the management of NAFLD. Furthermore, it will potentially identify factors that mediate improvement of NAFLD after VLCD. We will treat 10 subjects with obesity and NAFLD for 8 weeks with VLCD or lower calorie diet (control group) and obtain transient elastography before and after the interventions along with other measurements of interest. Our project may have significant impact by establishing VLCD as a clinically effective option for the improvement of liver steatosis and fibrosis in patients with obesity and NAFLD ineligible or without access to bariatric surgery.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 21 Apr 2021
- Start date
- 1 Oct 2023
- Primary completion date
- Jul 2026
- Lead sponsor
- University of Iowa
- Diseases
- Obesity, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT04861571
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 1 Oct 2023 to the primary completion date, Jul 2026
- 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.
Criteria the registry did not label
- Inclusion and Exclusion Criteria
- The inclusion criteria for participation are as follows:
- Male and female subjects with age ≥ 18 years old and \< 70 years old.
- BMI ≥ 30 kg/m2 and ≤ 50 kg/m2
- Negative tests for viral hepatitis C (hepatitis C antibody) and autoimmune hepatitis (anti-smooth muscle antibody)
- Evidence of liver steatosis on an image method such as ultrasound, CT scan or MRI, or subjects with elastography score F1 and above and/or S1 and above can be included
- The exclusion criteria are as follows:
- Type 1 diabetes mellitus
- Subjects with type 2 diabetes mellitus who use insulin
- Heart failure
- Myocardial infarction within last 6 months
- Unstable angina
- Chronic kidney disease with eGFR ≤ 30 mL/min/1.73 m²
- Chronic obstructive pulmonary disease requiring O2 supplementation
- Coexisting liver disease or end-stage liver disease
- Severe or uncontrolled mental health disease, including eating disorders
- Gout
- History of uric acid nephrolithiasis
- Porphyria
- Conception attempts, confirmed pregnancy or breast feeding
- Past or active cholecystitis without cholecystectomy
- Uncontrolled hyperthyroidism
- Uncontrolled hypothyroidism with TSH ≥ 10 mcIU/mL
- Excessive alcohol consumption (that is, an AUDIT-C score ≥ 4 for men and ≥ 3 for women)
- Use of warfarin, lithium, chronic use of prednisone (20mg or more daily)
- Subjects with no elastography in the previous 12 months will be excluded from the study
- Subjects with F0 and S0 on elastography will be excluded
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Iowa Health Care Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.