Effect of Caffeine Supplementation Compared to Placebo on Liver Fat Content and Scarring in Adults with Fatty Liver Disease: A Randomized Controlled Trial.

Randomized ,Quadruple-blind, Placebo-controlled, Clinical Trial to determine the effects of Coffee (caffeine) supplementation on Hepatic Steatosis and Fibrosis in Metabolic dysfunction-associated Steatotic Liver Disease(MASLD).

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2025/023

Enrollment

Unknown

Registered

2025-06-19

Start date

2025-06-22

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

MASLD

Interventions

The study will be conducted at the Department of Medicine, Faculty of Medicine, University of Kelaniya, in collaboration with the affiliated teaching hospital. Participants will be randomly assigned t

Eligibility

Inclusion criteria

Inclusion criteria: • Both male and non-pregnant, non-lactating female patients aged 18 - 65 years who provide written informed consent before starting the study • Patients meeting the diagnostic criteria for Metabolic dysfunction-associated steatotic liver disease (MASLD) (defined as hepatic steatosis on ultrasound [>=2 of the following: increased echogenicity vs. renal cortex, blurring of intrahepatic vessels, posterior beam attenuation] plus >=1 cardiometabolic risk factor [type 2 diabetes mellitus: Fasting Plasma Glucose (FPG) >=5.6 mmol/L, 2-hr post-load glucose >=7.8 mmol/L, Hemoglobin A1c(HbA1c) >=5.7%, or on antidiabetic treatment; Body Mass Index (BMI) >=23 kg/m²; hypertension >=130/85 mmHg or on antihypertensive medication; dyslipidemia: Triglycerides (TG) >=1.70 mmol/L or on lipid-lowering therapy, High-Density Lipoprotein Cholesterol (HDL-C) =94 cm (men) or >=80 cm (women)])) • Controlled Attenuation Parameter (CAP) score >263 • Fulfilling 2/3 USS criteria for fatty liver

Exclusion criteria

Exclusion criteria: • History of unsafe alcohol consumption ( Alcohol Use Disorders Identification Test -AUDIT score ?8) • Other liver disease (chronic viral/autoimmune/hereditary) • Use of steatogenic medications • History of drug dependence • Body mass index (BMI) >=35 kg/m2

Design outcomes

Primary

Measure	Time frame
The reduction in hepatic steatosis and hepatic fibrosis at 6 months compared to baseline, measured by the Controlled Attenuation Parameter (CAP) score using FibroScan, liver stiffness measurement via transient elastography (TE) using FibroScan, and FIB-4 scores. [Baseline, 6 months]	—

Secondary

Measure	Time frame
The reduction in AST and ALT levels in 6 months compared to baseline. [Baseline, 6 months]	—

Countries

Sri Lanka

Contacts

Public ContactAP De Silva

Vidyajothi Prof

apdsilva@yahoo.com

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 10, 2026