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

Primary Purpose

Nonalcoholic Fatty Liver Disease

Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
low free sugar diet
Sponsored by
National Nutrition and Food Technology Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonalcoholic Fatty Liver Disease

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Azita HekmatdoostRecruiting
  • National Nutrition and Food Technology Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

control

Arm Description

low free sugar diet with nutrition and exercise recommendation

regular diet with nutrition and exercise recommendation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 27, 2020
Last Updated
April 27, 2020
Sponsor
National Nutrition and Food Technology Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04369521
Brief Title
Evaluation of the Effects of a Low Free Sugar Diet in Patients With Nonalcoholic Fatty Liver Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 23, 2019 (Actual)
Primary Completion Date
May 9, 2020 (Anticipated)
Study Completion Date
July 21, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Nutrition and Food Technology Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Fatty Liver Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
low free sugar diet with nutrition and exercise recommendation
Arm Title
control
Arm Type
No Intervention
Arm Description
regular diet with nutrition and exercise recommendation
Intervention Type
Other
Intervention Name(s)
low free sugar diet
Intervention Description
low free sugar diet with nutrition and exercise recommendation
Primary Outcome Measure Information:
Title
ALT
Description
serum level of Alanine transaminase
Time Frame
12 weeks
Title
AST
Description
serum level of Aspartate transaminase
Time Frame
12 weeks
Title
GGT
Description
serum level of Gamma glutaminase
Time Frame
12 weeks
Title
TG
Description
serum level of Triglyceride
Time Frame
12 weeks
Title
Total cholesterol
Description
serum level of total cholesterol
Time Frame
12 weeks
Title
LDL-c
Description
serum level of LDL-Cholesterol
Time Frame
12 weeks
Title
HDL-c
Description
serum level of HDL-Cholesterol
Time Frame
12 weeks
Title
FBS
Description
serum level of Fasting blood sugar
Time Frame
12 weeks
Title
Insulin
Description
serum level of Insulin
Time Frame
12 weeks
Title
hs-CRP
Description
Serum level of high-sensitive C-reactive protein
Time Frame
12 weeks
Title
TNF-a
Description
Serum level of Tumor necrosis factor-a
Time Frame
12 weeks
Title
NF-kb
Description
Activity of Nuclear factor-B in peripheral monocellular cells
Time Frame
12 weeks
Title
Liver fibrosis
Description
Liver fibrosis according to fibroscan exam
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age of 18 to 60 years Body Mass Index (BMI) between 25-40 Sonographic findings compatible with hepatic steatosis (degree 2 or more) Exclusion Criteria: Alcohol consumption pregnancy or lactation Other liver disease (viral,cirrhosis,...) Use of drugs such as phenytoin,tamoxifen,lithium A history of Cancer, autoimmune disease,Renal disease & Celiac disease, hypothyroidism or Cushing's syndrome Lack of desire to continue studying Have to use antibiotics with hepatotoxic drugs while studying Non-compliance with diet
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Azita Hekmatdoost, MD,PhD
Phone
+989123065084
Email
a_hekmat2000@yahoo.com
Facility Information:
Facility Name
Azita Hekmatdoost
City
Tehran
State/Province
Middle East
ZIP/Postal Code
19835
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Azita Hekmatdoost, MD, PhD
Phone
+989123065084
Email
a_hekmat2000@yahoo.com
Facility Name
National Nutrition and Food Technology Research Institute
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Azita Hekmatdoost, MD, Ph.D

12. IPD Sharing Statement

Learn more about this trial

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

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