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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369521
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Dr Azita Hekmatdoost, 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.

Condition or disease Intervention/treatment Phase
Nonalcoholic Fatty Liver Disease Other: low free sugar diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 23, 2019
Estimated Primary Completion Date : May 9, 2020
Estimated Study Completion Date : July 21, 2020


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



Primary Outcome Measures :
  1. ALT [ Time Frame: 12 weeks ]
    serum level of Alanine transaminase

  2. AST [ Time Frame: 12 weeks ]
    serum level of Aspartate transaminase

  3. GGT [ Time Frame: 12 weeks ]
    serum level of Gamma glutaminase

  4. TG [ Time Frame: 12 weeks ]
    serum level of Triglyceride

  5. Total cholesterol [ Time Frame: 12 weeks ]
    serum level of total cholesterol

  6. LDL-c [ Time Frame: 12 weeks ]
    serum level of LDL-Cholesterol

  7. HDL-c [ Time Frame: 12 weeks ]
    serum level of HDL-Cholesterol

  8. FBS [ Time Frame: 12 weeks ]
    serum level of Fasting blood sugar

  9. Insulin [ Time Frame: 12 weeks ]
    serum level of Insulin

  10. hs-CRP [ Time Frame: 12 weeks ]
    Serum level of high-sensitive C-reactive protein

  11. TNF-a [ Time Frame: 12 weeks ]
    Serum level of Tumor necrosis factor-a

  12. NF-kb [ Time Frame: 12 weeks ]
    Activity of Nuclear factor-B in peripheral monocellular cells

  13. Liver fibrosis [ Time Frame: 12 weeks ]
    Liver fibrosis according to fibroscan exam



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369521


Contacts
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Contact: Azita Hekmatdoost, MD,PhD +989123065084 a_hekmat2000@yahoo.com

Locations
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Iran, Islamic Republic of
Azita Hekmatdoost Recruiting
Tehran, Middle East, Iran, Islamic Republic of, 19835
Contact: Azita Hekmatdoost, MD, PhD    +989123065084    a_hekmat2000@yahoo.com   
National Nutrition and Food Technology Research Institute Recruiting
Tehran, Iran, Islamic Republic of
Contact: Azita Hekmatdoost, MD, Ph.D         
Sponsors and Collaborators
National Nutrition and Food Technology Institute
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Responsible Party: Dr Azita Hekmatdoost, principal investigator, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier: NCT04369521    
Other Study ID Numbers: 22300
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases