Evaluation of the Effects of a Low Free Sugar Diet in Patients With Nonalcoholic Fatty Liver Disease

National Nutrition and Food Technology Institute

Status: Unknown

Conditions: Nonalcoholic Fatty Liver Disease

Treatments: Other: low free sugar diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04369521

22300

Details and patient eligibility

About

To study the effects of a low free sugar diet on lipid profile, glycemic indices, liver enzymes, inflammatory factors and hepatic steatosis and fibrosis in patients with Nonalcoholic fatty liver disease, 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 2 and 3 will be randomly allocated to receive low free sugar diet or regular diet for 12 weeks; both groups will be advised to adherence the investigators' nutrition recommendation and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes,glycemic indices, some inflammatory markers, and liver fibrosis will be assessed and compared between groups.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age of 18 to 60 years
2. Body Mass Index (BMI) between 25-40
3. Sonographic findings compatible with hepatic steatosis (degree 2 or more)

Exclusion criteria

1. Alcohol consumption
2. pregnancy or lactation
3. Other liver disease (viral,cirrhosis,...)
4. Use of drugs such as phenytoin,tamoxifen,lithium
5. A history of Cancer, autoimmune disease,Renal disease & Celiac disease, hypothyroidism or Cushing's syndrome
6. Lack of desire to continue studying
7. Have to use antibiotics with hepatotoxic drugs while studying
8. Non-compliance with diet

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Intervention

Experimental group

Description:

low free sugar diet with nutrition and exercise recommendation

Treatment:

Other: low free sugar diet

control

No Intervention group

Description:

regular diet with nutrition and exercise recommendation