Treatment of non-alcoholic fatty liver disease

The effect of genistein supplementation on inflammatory and oxidative indices and lipid profile in non-alcoholic fatty liver patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201312132480N5

Enrollment

100

Registered

2015-07-11

Start date

2015-07-06

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Non alcoholic fatty liver. Fatty (change of) liver, not elsewhere classified

Interventions

Intervention 1: Intervention group: 250 mg genistein as capsule once per day for 8 weeksmanufacture company: BOC SCI. Intervention 2: Control group: wheat starch in capsule once a day for 8 weeks.

Treatment - Drugs

Placebo

Intervention group: 250 mg genistein as capsule once per day for 8 weeksmanufacture company: BOC SCI

Control group: wheat starch in capsule once a day for 8 weeks

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Volunteers whom their fatty liver were confirmed by ultrasonography; Don't have any Acute or chronic disease of the liver or bile ducts Exclusion criteria: Severe weight loss or gain; Pregnancy; ALT serum level 10 times more than normal range.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Malondialdehyde. Timepoint: Before intervention and two months after intervention inception. Method of measurement: By serum analysis.;Liver steatosis. Timepoint: Before intervention and two months after intervention inception. Method of measurement: By fibroscan device.;TNF- alpha. Timepoint: Before intervention and two months after intervention inception. Method of measurement: By serum analysis.;IL-6. Timepoint: Before intervention and two months after intervention inception. Method of measurement: By serum analysis.;ALT. Timepoint: Before intervention and two months after intervention inception. Method of measurement: By serum analysis.;AST. Timepoint: Before intervention and two months after intervention inception. Method of measurement: By serum analysis.;HDL. Timepoint: Before intervention and two months after intervention inception. Method of measurement: By serum analysis.;LDL. Timepoint: Before intervention and two months after intervention inception. Method of measurement: By serum analysis.;Total cholesetrol. Timepoint: Before intervention and two months after intervention inception. Method of measurement: By serum analysis.;Triglyceride. Timepoint: Before intervention and two months after intervention inception. Method of measurement: By serum analysis.	—

Measure

Time frame

Malondialdehyde. Timepoint: Before intervention and two months after intervention inception. Method of measurement: By serum analysis.;Liver steatosis. Timepoint: Before intervention and two months after intervention inception. Method of measurement: By fibroscan device.;TNF- alpha. Timepoint: Before intervention and two months after intervention inception. Method of measurement: By serum analysis.;IL-6. Timepoint: Before intervention and two months after intervention inception. Method of measurement: By serum analysis.;ALT. Timepoint: Before intervention and two months after intervention inception. Method of measurement: By serum analysis.;AST. Timepoint: Before intervention and two months after intervention inception. Method of measurement: By serum analysis.;HDL. Timepoint: Before intervention and two months after intervention inception. Method of measurement: By serum analysis.;LDL. Timepoint: Before intervention and two months after intervention inception. Method of measurement: By serum analysis.;Total cholesetrol. Timepoint: Before intervention and two months after intervention inception. Method of measurement: By serum analysis.;Triglyceride. Timepoint: Before intervention and two months after intervention inception. Method of measurement: By serum analysis.

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Secondary

Measure	Time frame
Waist circumference. Timepoint: Before and two months after intervention inception. Method of measurement: By tapeline in cm.;Waist circumference. Timepoint: Before and two months after intervention inception. Method of measurement: By scale in KG.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSasan Amanat

Shiraz University of Medical Sciences

snatm69@gmail.com+98 717251008

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026