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

NCT ID: NCT03377140

Last Updated: 2017-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-03-20

Brief Summary

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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.

Detailed Description

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Conditions

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Non Alcoholic Steatohepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Hesperidin

2 capsuls of Hesperidin

Group Type ACTIVE_COMPARATOR

Hesperidin

Intervention Type DIETARY_SUPPLEMENT

2 capsuls

control

2 capsuls of placebo

Group Type PLACEBO_COMPARATOR

control

Intervention Type OTHER

2 capsuls

Interventions

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Hesperidin

2 capsuls

Intervention Type DIETARY_SUPPLEMENT

control

2 capsuls

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Nutrition and Food Technology Institute

OTHER

Sponsor Role lead

Responsible Party

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Dr Azita Hekmatdoost

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Nutrition and Food Technology Research Institute

Tehran, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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azita Hekmatdoost, MD.PhD

Role: CONTACT

Phone: +98-21-22077424

Email: [email protected]

Facility Contacts

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Azits Hekmatdoost

Role: primary

Other Identifiers

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6756

Identifier Type: -

Identifier Source: org_study_id