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

NCT03377140 | Unknown DMC

• 1 other identifier: 6756
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Alcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• liver fibrosis

  assess by fibroscan

  12 weeks

Secondary Outcomes (1)

• body mass index

  12 weeks

Study Arms (2)

Hesperidin

ACTIVE COMPARATOR

2 capsuls of Hesperidin

Dietary Supplement: Hesperidin

control

PLACEBO COMPARATOR

2 capsuls of placebo

Other: control

Interventions

Hesperidin DIETARY_SUPPLEMENT

2 capsuls

Hesperidin

control OTHER

2 capsuls

control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Nutrition and Food Technology Institute: lead

Study Sites (1)

National Nutrition and Food Technology Research Institute

Tehran, Iran

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Hesperidin

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Flavanones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glycosides; Carbohydrates

Central Study Contacts

azita Hekmatdoost, MD.PhD

CONTACT

+98-21-22077424; a_hekmat2000@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 19, 2017
• Study Start: June 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: March 20, 2018
• Last Updated: December 19, 2017

Record last verified: 2017-04

Locations

IR (1)