Impact of very low-calorie diets on liver health in obese individuals with 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

This study is testing if an 8-week very low-calorie diet can help improve liver health in obese adults with non-alcoholic fatty liver disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: University of Iowa (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Iowa City, Iowa)
• Trial ID: NCT04861571 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effects of an 8-week very low-calorie diet (VLCD) on liver steatosis and fibrosis in adults with obesity and non-alcoholic fatty liver disease (NAFLD). Participants will undergo a controlled, non-randomized, open-label intervention where their liver health will be assessed using non-invasive elastography before and after the VLCD. The study aims to determine if significant weight loss achieved through VLCD can improve liver conditions associated with obesity. The trial is conducted at the University of Iowa Health Care, focusing on individuals with specific eligibility criteria related to liver health and obesity.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with a BMI between 30 and 50 who have evidence of liver steatosis and fibrosis but do not have other significant health issues.

Not a fit: Patients with type 1 diabetes, severe heart or kidney disease, or other significant liver conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could provide a non-surgical option for improving liver health in obese patients with NAFLD.

How similar studies have performed: Previous studies have shown that dietary interventions can lead to significant improvements in liver health, suggesting potential success for this approach.

Eligibility criteria

Inclusion and Exclusion Criteria

The inclusion criteria for participation are as follows:

1. Male and female subjects with age ≥ 18 years old and \< 70 years old.
2. BMI ≥ 30 kg/m2 and ≤ 50 kg/m2
3. Negative tests for viral hepatitis C (hepatitis C antibody) and autoimmune hepatitis (anti-smooth muscle antibody)
4. 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:

1. Type 1 diabetes mellitus
2. Subjects with type 2 diabetes mellitus who use insulin
3. Heart failure
4. Myocardial infarction within last 6 months
5. Unstable angina
6. Chronic kidney disease with eGFR ≤ 30 mL/min/1.73 m²
7. Chronic obstructive pulmonary disease requiring O2 supplementation
8. Coexisting liver disease or end-stage liver disease
9. Severe or uncontrolled mental health disease, including eating disorders
10. Gout
11. History of uric acid nephrolithiasis
12. Porphyria
13. Conception attempts, confirmed pregnancy or breast feeding
14. Past or active cholecystitis without cholecystectomy
15. Uncontrolled hyperthyroidism
16. Uncontrolled hypothyroidism with TSH ≥ 10 mcIU/mL
17. Excessive alcohol consumption (that is, an AUDIT-C score ≥ 4 for men and ≥ 3 for women)
18. Use of warfarin, lithium, chronic use of prednisone (20mg or more daily)
19. Subjects with no elastography in the previous 12 months will be excluded from the study
20. Subjects with F0 and S0 on elastography will be excluded

Where this trial is running

Iowa City, Iowa

• University of Iowa Health Care — Iowa City, Iowa, United States (Recruiting)

Study contacts

• Principal investigator: Marcelo L Correia, MD PhD — University of Iowa
• Study coordinator: Marcelo L Correia, MD PhD

Conditions NAFLD