Formula Diet Treatment for NASH Patients.

West German Center of Diabetes and Health

Status: Active, not recruiting

Conditions: Steatohepatitis, Nonalcoholic

Treatments: Dietary Supplement: Formula diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04707651

NASH

Details and patient eligibility

About

Non-alcoholic steatohepatitis (NASH) - also called fatty liver - is medically a serious problem because the liver tissue becomes fatty and stiff, and inflammatory reactions occur. This increases the risk of liver fibrosis (= scarring of the liver), liver cirrhosis (= shrunken liver), a liver tumor or death. So far there is no recognized treatment option for this disease. However, there is evidence that a lifestyle change based on a reduced carbohydrate diet, more exercise and a significant weight loss that can improve NASH.

Full description

Outpatients with NASH will be included into this lifestyle intervention study. Patients will get nutritional advices and a formula diet for 12 weeks. Clinical visits will take place at baseline, after 4, 12 and after 52 weeks.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI>25 kg/qm

Exclusion criteria

• history of drug or alcohol abuse
• acute or chronic diseases (except type 2 diabetes)
• pregnancy or breast feeding

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Lifestyle intervention

Experimental group

Description:

Nutrition advices and formula diet

Treatment:

Dietary Supplement: Formula diet