NCT07768956

Brief Summary

Non-alcoholic fatty liver disease (NAFLD) is a common liver condition associated with metabolic disorders and lifestyle factors. This study aims to evaluate the effects of Turkish coffee and green tea consumption in addition to a Mediterranean diet intervention on liver fat content, biochemical parameters, and anthropometric measurements in individuals with fatty liver disease. Participants received a 12-week Mediterranean diet program and were assigned to groups consuming Turkish coffee, green tea, or no additional beverage intervention. Changes in liver ultrasonography findings, liver enzymes, metabolic parameters, and body measurements were evaluated before and after the intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 17, 2026

Completed
Last Updated

August 17, 2026

Status Verified

July 1, 2026

Enrollment Period

11 months

First QC Date

August 4, 2026

Last Update Submit

August 12, 2026

Conditions

Keywords

non-alcoholic fatty liver disease, Turkish coffee, green tea, diet therapy

Outcome Measures

Primary Outcomes (1)

  • Change in liver steatozis grade by abdominal Ultrasonography

    Liver steatosis was assessed by abdominal ultrasonography and graded as Grade 0 (no steatosis), Grade 1 (mild steatosis), Grade 2 (moderate steatosis), and Grade 3 (severe steatosis). Higher grades indicate greater severity of hepatic steatosis.

    Baseline and 12 weeks

Secondary Outcomes (3)

  • Change in Alanine Aminotransferase (ALT) Level (U/L)

    Baseline and 12 Weeks

  • Change in Aspartate Aminotransferase (AST) Level (U/L)

    Baseline and Week 12

  • Change in Gamma-Glutamyl Transferase (GGT) Level (U/L)

    Baseline and Week 12

Other Outcomes (9)

  • Change in Body Weight (kg)

    Baseline and Week 12

  • Change in Body Mass Index (BMI) (kg/m²)

    Baseline and Week 12

  • Change in Waist Circumference (cm)

    Baseline and Week 12

  • +6 more other outcomes

Study Arms (3)

Mediterranean Diet + Green Tea

EXPERIMENTAL

Participants received a Mediterranean diet intervention and consumed green tea three times daily as an adjunct to the diet for 12 weeks.

Behavioral: green teaBehavioral: mediterranean diet

Mediterranean Diet + Turkish Coffee

EXPERIMENTAL

Participants received a Mediterranean diet intervention and consumed Turkish coffee twice daily for 12 weeks

Behavioral: Turkish CoffeeBehavioral: mediterranean diet

Mediterranean Diet Control

ACTIVE COMPARATOR

Participants received a Mediterranean diet intervention without additional Turkish coffee or green tea consumption for 12 weeks.

Behavioral: mediterranean diet

Interventions

green teaBEHAVIORAL

Participants consumed green tea three times daily as an adjunct to a Mediterranean diet intervention for 12 weeks.

Mediterranean Diet + Green Tea
Turkish CoffeeBEHAVIORAL

Participants consumed Turkish coffee twice daily as an adjunct to a Mediterranean diet intervention for 12 weeks.

Mediterranean Diet + Turkish Coffee

participants received a Mediterranean diet intervention without additional Turkish coffee or green tea consumption for 12 weeks.

Mediterranean Diet + Green TeaMediterranean Diet + Turkish CoffeeMediterranean Diet Control

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants aged 19-65 years with a diagnosis of non-alcoholic fatty liver disease (NAFLD).
  • Not using medications for diabetes, dyslipidemia, or rheumatoid arthritis.
  • Not using dietary supplements.
  • No dietary program followed within the previous month.
  • No severe psychiatric disorders.
  • Willingness to participate in the study and provide informed consent.

You may not qualify if:

  • Presence of diabetes, dyslipidemia, or rheumatoid arthritis.
  • Alcohol consumption.
  • Positive hepatitis B surface antigen (HBsAg), hepatitis C positivity, autoimmune hepatitis, liver cirrhosis, toxic hepatitis, or alanine aminotransferase (ALT) levels ≥10 times the upper limit of normal.
  • Presence of liver malignancy or hepatic decompensation.
  • Use of systemic corticosteroids or methotrexate within the previous 6 months.
  • Pregnancy or lactation.
  • Regular use of dietary supplements.
  • Following a dietary program within the previous month.
  • Presence of severe psychiatric disorders.
  • High daily consumption of tea and coffee.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Dr. Lutfi Kirdar City Hospital

Istanbul, Istanbul, 34865, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

TeaDiet, Mediterranean

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesDiet, Plant-BasedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological Phenomena

Study Officials

  • Hande Öngün Yılmaz, PhD

    BANDIRMA ONYEDI EYLUL UNIVERSITY, BANDIRMA VOCATIONAL SCHOOL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This is a 12-week, three-arm, parallel-group randomized controlled study. Participants were assigned to one of three groups: Turkish coffee group, green tea group, or control group. All participants received a Mediterranean diet intervention. In addition, the Turkish coffee group consumed Turkish coffee twice daily, and the green tea group consumed green tea three times daily. The control group received the Mediterranean diet intervention without additional beverage supplementation.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2026

First Posted

August 17, 2026

Study Start

September 25, 2024

Primary Completion

August 15, 2025

Study Completion

August 15, 2025

Last Updated

August 17, 2026

Record last verified: 2026-07

Locations