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

Not Applicable

• Conditions: Nonalcoholic Fatty Liver Disease
• Interventions: Other: low free sugar diet

• Registration Number: NCT04369521
• Lead Sponsor: National Nutrition and Food Technology Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-23
• Status Verified: 2020-04
• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-04-27
• Last Update Submitted: 2020-04-27
• Study First Posted: 2020-04-30
• Last Update Posted: 2020-04-30
• Primary Completion: 2020-05-09
• Study Completion: 2020-07-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	low free sugar diet	low free sugar diet with nutrition and exercise recommendation

Primary Outcome Measures

Name	Time	Method
ALT	12 weeks	serum level of Alanine transaminase
LDL-c	12 weeks	serum level of LDL-Cholesterol
hs-CRP	12 weeks	Serum level of high-sensitive C-reactive protein
AST	12 weeks	serum level of Aspartate transaminase
GGT	12 weeks	serum level of Gamma glutaminase
TG	12 weeks	serum level of Triglyceride
HDL-c	12 weeks	serum level of HDL-Cholesterol
Insulin	12 weeks	serum level of Insulin
TNF-a	12 weeks	Serum level of Tumor necrosis factor-a
Liver fibrosis	12 weeks	Liver fibrosis according to fibroscan exam
FBS	12 weeks	serum level of Fasting blood sugar
NF-kb	12 weeks	Activity of Nuclear factor-B in peripheral monocellular cells
Total cholesterol	12 weeks	serum level of total cholesterol

Trial Locations

Locations (2)

Azita Hekmatdoost; 🇮🇷 Tehran, Middle East, Iran, Islamic Republic of

National Nutrition and Food Technology Research Institute; 🇮🇷 Tehran, Iran, Islamic Republic of