NCT07133373

Brief Summary

This randomized controlled trial aims to evaluate the short-term effects of daily unfiltered Turkish coffee consumption on cardiovascular parameters, appetite-regulating hormones, glucose metabolism, inflammatory markers, and sleep quality in healthy young women. Forty participants will be randomly assigned to an intervention group, consuming standardized servings of Turkish coffee for four weeks, or to a control group abstaining from coffee during the same period. Measurements will be taken at baseline and after the intervention, including blood pressure, lipid profile, leptin, ghrelin, glucose metabolism markers, inflammatory biomarkers, body composition, and sleep quality indices.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

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

August 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 21, 2025

Completed
Last Updated

August 21, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

August 5, 2025

Last Update Submit

August 13, 2025

Conditions

Keywords

Turkish coffeecaffeineyoung femalecardiovascular healthinsomniaappetite

Outcome Measures

Primary Outcomes (1)

  • Change in systolic and diastolic blood pressure after 4 weeks of Turkish coffee consumption

    Systolic and diastolic blood pressure were measured at baseline and after 4 weeks using a validated electronic monitor (Omron M6). Participants were seated in a relaxed position, and the average of two readings was recorded. The change in blood pressure levels was used to assess cardiovascular effects of Turkish coffee consumption.

    Baseline and Week 4

Secondary Outcomes (1)

  • Change in serum leptin and ghrelin levels after 4 week

    Baseline and Week 4

Study Arms (2)

Intervention

EXPERIMENTAL

Standardized Turkish coffee (unfiltered and boiled) was administered once daily for 4 weeks. Each serving was approximately 75 mL, prepared using a consistent protocol without added sugar or milk. The coffee was sourced from the same batch and brewed in a traditional cezve. Compliance and adverse effects were monitored throughout the intervention.

Other: Turkish Coffee (unfiltered, boiled)

control

NO INTERVENTION

Participants assigned to the control group were instructed to avoid all forms of coffee for the duration of the 4-week intervention period. They did not receive any dietary or behavioral instructions beyond abstaining from coffee consumption.

Interventions

Standardized Turkish coffee (unfiltered and boiled) was administered once daily for 4 weeks. Each serving was approximately 75 mL, prepared using a consistent protocol without added sugar or milk. The coffee was sourced from the same batch and brewed in a traditional cezve. Compliance and adverse effects were monitored throughout the intervention.

Also known as: case group
Intervention

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy female participants aged between 18 and 35 years
  • Body Mass Index (BMI) between 18.5 and 29.9 kg/m²
  • Habitual coffee consumers (1-2 cups/day)
  • Not on a weight-loss or special medical diet
  • Not taking medications or supplements that affect sleep, appetite, metabolism, or cardiovascular function
  • Non-smokers and not using recreational drugs
  • Willing to comply with study protocol and attend all assessments

You may not qualify if:

  • Pregnancy or lactation
  • Diagnosed chronic diseases (e.g., diabetes, hypertension, cardiovascular disease)
  • Known sleep disorders or psychological conditions
  • Allergy or sensitivity to coffee or caffeine
  • Irregular menstrual cycle or hormonal disorders
  • Shift workers or frequent travelers across time zones
  • Participation in other clinical trials within the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UOP

Amman, 961343, Jordan

Location

MeSH Terms

Conditions

InflammationSleep Initiation and Maintenance Disorders

Interventions

Diagnosis-Related Groups

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Prospective Payment SystemReimbursement MechanismsInsurance, Health, ReimbursementFinancing, OrganizedEconomicsHealth Care Economics and Organizations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No blinding was implemented. Both participants and researchers were aware of group assignment due to the nature of the intervention (coffee consumption).
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a two-arm parallel randomized controlled trial. Participants were randomly assigned to either the intervention group (consuming Turkish coffee daily for 4 weeks) or the control group (no coffee consumption). Both groups were followed in parallel during the study period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Amman. Jordan

Study Record Dates

First Submitted

August 5, 2025

First Posted

August 21, 2025

Study Start

August 1, 2024

Primary Completion

October 30, 2024

Study Completion

October 30, 2024

Last Updated

August 21, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

The individual participant data (IPD) will not be shared due to confidentiality concerns and ethical limitations related to the nature of the data collected. The data include sensitive health and behavioral variables that cannot be adequately de-identified.

Locations