Effect of green coffee bean extract supplementation on nonalcoholic fatty liver disease

Supplementation effect of green coffee bean extract on lipid profile, inflammatory and oxidative stress biomarkers, insulin resistance and liver enzymes in overweight and obese patients with nonalcoholic fatty liver disease(NAFLD).

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016030626941N1

Enrollment

Registered

2016-04-19

Start date

2016-03-24

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

Nonalcoholic Fatty Liver Disease. Fatty (change of) liver, not elsewhere classified

Interventions

Intervention 1: Intervention group: All patients will receive 1g green coffee bean extract capsules once daily for 8 weeks. Intervention 2: Control group: All patients will receive 1g placebo capsule

Treatment - Drugs

Intervention group: All patients will receive 1g green coffee bean extract capsules once daily for 8 weeks.

Control group: All patients will receive 1g placebo capsules (Nokhodchi flour) once daily for 8 weeks.

Eligibility

Sex/Gender

All

Age

20 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Men or women aged between 20 to 70 years old who will be diagnosed with NAFLD by ultrasonography scan (with steatosis score equal or greater than 1) and increased levels of liver enzymes (serum levels of alanine aminotransferase and aspartate aminotransferase more than 40 U/L); and Body Mass Index (BMI) of them is grater than 24.9 and lower than 35. Exclusion criteria: Alcohol consumption; Pregnant and lactating women; Any known forms of hepatic or metabolic disease except NAFLD, such as hereditary hemochromatosis, Wilson’s disease, cirosis, diabetes and other metabolic disease; Any history of gastric bypass or intestine surgery; Taking hepatotoxic drugs such as calcium channel blocker, methotrexate, amiodarone, chloroquine and anti inflammatory drugs; Using nutrition supplements; Hormone Therapy; and Patients with a history of hypothyroidism, Cushing’s syndrome, renal failure, and kidney stones.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Liver steatosis index. Timepoint: Before and after intervention. Method of measurement: Sonography.;Insulin Resistance (IR). Timepoint: Before and after intervention. Method of measurement: Based on HOMA IR equation.;Liver enzymes (ALT, AST, ALP). Timepoint: Before and after intervention. Method of measurement: Microgram/ml - laboratory kit.;Tomor necrosis factor alpha (TNF alpha). Timepoint: Before and after intervention. Method of measurement: ELISA.;Serum Total Anti Oxidant Capacity (TAOC). Timepoint: Before and after intervention. Method of measurement: ELISA.;High sensitive C reactive protein. Timepoint: Before and after intervention. Method of measurement: ELISA.;Blood free fatty acids. Timepoint: Before and after intervention. Method of measurement: ELISA.;Lipid profile (TG, LDL, HDL, Total cholestrol). Timepoint: Before and after intervention. Method of measurement: laboratory kit.;Fasting Blood Sugar (FBS). Timepoint: Before and after intervention. Method of measurement: Colorimetric enzymatic method.;Insulin. Timepoint: Before and after intervention. Method of measurement: ELISA.	—

Measure

Time frame

Liver steatosis index. Timepoint: Before and after intervention. Method of measurement: Sonography.;Insulin Resistance (IR). Timepoint: Before and after intervention. Method of measurement: Based on HOMA IR equation.;Liver enzymes (ALT, AST, ALP). Timepoint: Before and after intervention. Method of measurement: Microgram/ml - laboratory kit.;Tomor necrosis factor alpha (TNF alpha). Timepoint: Before and after intervention. Method of measurement: ELISA.;Serum Total Anti Oxidant Capacity (TAOC). Timepoint: Before and after intervention. Method of measurement: ELISA.;High sensitive C reactive protein. Timepoint: Before and after intervention. Method of measurement: ELISA.;Blood free fatty acids. Timepoint: Before and after intervention. Method of measurement: ELISA.;Lipid profile (TG, LDL, HDL, Total cholestrol). Timepoint: Before and after intervention. Method of measurement: laboratory kit.;Fasting Blood Sugar (FBS). Timepoint: Before and after intervention. Method of measurement: Colorimetric enzymatic method.;Insulin. Timepoint: Before and after intervention. Method of measurement: ELISA.

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Secondary

Measure	Time frame
Waist to hip ratio. Timepoint: Before and after intervention. Method of measurement: Non-stretchable tape without any pressure.;Body Mass Index (BMI). Timepoint: Before and after intervention. Method of measurement: Weight (kilograms) divided by the square of height (meters).;Sistolic and diastolic blood pressure. Timepoint: Before and after intervention. Method of measurement: By mercury sphygmomanometer.	—

Measure

Time frame

Waist to hip ratio. Timepoint: Before and after intervention. Method of measurement: Non-stretchable tape without any pressure.;Body Mass Index (BMI). Timepoint: Before and after intervention. Method of measurement: Weight (kilograms) divided by the square of height (meters).;Sistolic and diastolic blood pressure. Timepoint: Before and after intervention. Method of measurement: By mercury sphygmomanometer.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHedayat allah shahmohammadi

Ahvaz Jundishapur University of Medical Sciences

shahmohammadi.h@ajums.ac.ir+98 61 3333 3050

Outcome results

None listed

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