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
National Nutrition and Food Technology Institute
Information provided by (Responsible Party):
Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
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.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
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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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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Age of 18 to 70 years
Body Mass Index (BMI) between 25-40
Sonographic findings compatible with hepatic steatosis (degree 2 or more)
Taking any kind of antibiotics two weeks before recruitment
History of alcohol consumption
pregnancy or lactation
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