Clinical trial

Effect of VLCD on the Reduction of Liver Steatosis and Fibrosis in Subjects With Obesity and NAFLD

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT04861571

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionNAFLD

Full registry 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

Treatments and study arms

Dietary intervention with very low calorie diet (VLCD)

Dietary Supplement

The VLCD program will last 8 weeks. The only sources of nutrition during this phase are the Optifast® products providing up to 800 kcal per day. Two liters (67.63 fl oz) of water should also be consumed each day. Participants will be instructed to use 5 replacement meals per day (800 kcal total) with 40% of calories as protein, 40% as carbohydrate, and 20% as fat.

Control Arm

Other

The control group will consume a lower calorie diet and will be instructed to reduce their usual intake of normally consumed foods by up to 500 kcal per day but no less than 1200 kcal per day.

Primary outcomes

Liver steatosis8 weeks

The investigators will assess the effect of VLCD on liver steatosis using transient elastography. The elastography parameter of interest is the controlled attenuation parameter (CAP) reported as a continuous variable in decibel per meter (dB/m).

Liver fibrosis8 weeks

The investigators will assess the effect of VLCD on liver fibrosis using transient elastography. The elastography parameter of interest is the liver stiffness measurement (LFM) reported as a continuous variable in kilopascal (kPa).

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Iowa Health Care🇺🇸 Iowa City, Iowa, United States

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