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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03377140

Enrollment

Registered

2017-12-19

Start date

2017-06-01

Completion date

2018-03-20

Last updated

2017-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Alcoholic Steatohepatitis

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.

Interventions

DIETARY_SUPPLEMENTHesperidin

2 capsuls

OTHERcontrol

2 capsuls

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
liver fibrosis	12 weeks	assess by fibroscan

Secondary

Measure	Time frame	Description
body mass index	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.

Countries

Iran

Contacts

Primary Contactazita Hekmatdoost, MD.PhD

a_hekmat2000@yahoo.com+98-21-22077424

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026