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

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

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.

Study Overview

• Status: Unknown
• Conditions: Nonalcoholic Fatty Liver Disease
• Intervention / Treatment: Other: low free sugar diet

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Azita Hekmatdoost, MD,PhD; Phone Number: +989123065084; Email: a_hekmat2000@yahoo.com

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Recruiting
    • National Nutrition and Food Technology Research Institute
    • Contact: Azita Hekmatdoost, MD, Ph.D
  • Middle East
    • Tehran, Middle East, Iran, Islamic Republic of, 19835
      • Recruiting
      • Azita Hekmatdoost
      • Contact: Azita Hekmatdoost, MD, PhD; Phone Number: +989123065084; Email: a_hekmat2000@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; low free sugar diet with nutrition and exercise recommendation	Other: low free sugar diet; low free sugar diet with nutrition and exercise recommendation
No Intervention: control; regular diet with nutrition and exercise recommendation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Nutrition and Food Technology Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2019
• Primary Completion (Anticipated): May 9, 2020
• Study Completion (Anticipated): July 21, 2020

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 30, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 22300

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No