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

Nonalcoholic Fatty Liver Disease Clinical Trial

Official title:

Evaluation of 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04369521
• Other study ID #: 22300
• Status: Recruiting
• Phase: N/A
• Start date: October 23, 2019
• Est. completion date: July 21, 2020

Study information

• Verified date: April 2020
• Source: National Nutrition and Food Technology Institute
• Contact: Azita Hekmatdoost, MD,PhD
• Phone: +989123065084
• Email: a_hekmat2000[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 21, 2020
• Est. primary completion date: May 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease

Intervention

Other:
• low free sugar diet
low free sugar diet with nutrition and exercise recommendation

Locations

Country	Name	City	State
Iran, Islamic Republic of	Azita Hekmatdoost	Tehran	Middle East
Iran, Islamic Republic of	National Nutrition and Food Technology Research Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
National Nutrition and Food Technology Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

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