NCT04369521

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 23, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2020

Completed
Last Updated

April 30, 2020

Status Verified

April 1, 2020

Enrollment Period

7 months

First QC Date

April 27, 2020

Last Update Submit

April 27, 2020

Conditions

Nonalcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (13)

  • 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

Study Arms (2)

Intervention

EXPERIMENTAL

low free sugar diet with nutrition and exercise recommendation

Other: low free sugar diet

control

NO INTERVENTION

regular diet with nutrition and exercise recommendation

Interventions

low free sugar dietOTHER

low free sugar diet with nutrition and exercise recommendation

Intervention

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Azita Hekmatdoost

Tehran, Middle East, 19835, Iran

RECRUITING

National Nutrition and Food Technology Research Institute

Tehran, Iran

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Central Study Contacts

Azita Hekmatdoost, MD,PhD

CONTACT

+989123065084a_hekmat2000@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

April 27, 2020

First Posted

April 30, 2020

Study Start

October 23, 2019

Primary Completion

May 9, 2020

Study Completion

July 21, 2020

Last Updated

April 30, 2020

Record last verified: 2020-04

Locations

IR(2)