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The Effects of Hesperidin on Biochemical Factors and Hepatic Fibrosis in Nonalcoholic Fatty Liver Disease

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ClinicalTrials.gov Identifier: NCT03377140
Recruitment Status : Unknown
Verified April 2017 by Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute.
Recruitment status was:  Recruiting
First Posted : December 19, 2017
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute

Brief Summary:
To study the effects of Hesperidin supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 2 and 3 will be randomly allocated to receive placebos or 2 capsules Hesperidin for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory markers, and liver fibrosis will be assessed and compared between groups.

Condition or disease Intervention/treatment Phase
Non Alcoholic Steatohepatitis Dietary Supplement: Hesperidin Other: control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Effects of Hesperidin Supplementation on Hepatic Enzymes, Inflammatory Factors, Lipid Profile, Blood Glucose, Insulin Sensitivity, and Hepatic Steatosis Grade in Patients With Non-alcoholic Fatty Liver Disease
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : February 1, 2018
Estimated Study Completion Date : March 20, 2018


Arm Intervention/treatment
Active Comparator: Hesperidin
2 capsuls of Hesperidin
Dietary Supplement: Hesperidin
2 capsuls

Placebo Comparator: control
2 capsuls of placebo
Other: control
2 capsuls




Primary Outcome Measures :
  1. liver fibrosis [ Time Frame: 12 weeks ]
    assess by fibroscan


Secondary Outcome Measures :
  1. body mass index [ Time Frame: 12 weeks ]
    The body mass index (BMI) or Quetelet index is a value derived from the mass (weight) and height of an individual. The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age of 18 to 70 years
  • Body Mass Index (BMI) between 25-40
  • Sonographic findings compatible with hepatic steatosis (degree 2 or more)

Exclusion Criteria:

  • Diabetes
  • Taking any kind of antibiotics two weeks before recruitment
  • History of alcohol consumption
  • pregnancy or lactation
  • Professional athletes
  • Other liver disease (viral/etc)
  • Use of drugs such as calcium channel blockers, high dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs, lipid-lowering agents, metformin and vitamin E
  • A history of Hypertension, Cardiovascular disease, Pulmonary disease, Renal disease & Celiac disease; Cirrhosis
  • History of Upper GI surgery / Prior surgical procedures such as jejunoileal or jejunocolic bypass, gastroplasty
  • Following program to lose weight in recent 3 mo
  • A history of hypothyroidism or Cushing's syndrome

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): NCT03377140


Contacts
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Contact: azita Hekmatdoost, MD.PhD +98-21-22077424 a_hekmat2000@yahoo.com

Locations
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Iran, Islamic Republic of
National Nutrition and Food Technology Research Institute Recruiting
Tehran, Iran, Islamic Republic of
Contact: Azits Hekmatdoost         
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: NCT03377140     History of Changes
Other Study ID Numbers: 6756
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: April 2017

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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