NCT06754748

Brief Summary

This study investigates how caffeinated coffee, decaffeinated coffee, and water affect body composition, as measured by BIA. Participants were divided into three groups, consuming their respective beverages, with measurements taken over a 120-minute period. The study aimed to determine if caffeine or fluid intake is the primary driver of changes in body composition parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

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

February 25, 2023

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 1, 2025

Completed
Last Updated

January 1, 2025

Status Verified

December 1, 2024

Enrollment Period

28 days

First QC Date

December 23, 2024

Last Update Submit

December 23, 2024

Conditions

Body Composition Measurement

Keywords

Bioelectrical Impedance AnalysisCaffeineHydrationBody Composition

Outcome Measures

Primary Outcomes (5)

  • Change in Body Fat Mass

    BIA measurements were recorded for the body fat mass (kg) at baseline, 30, 60, 90, and 120 minutes.

    Baseline, 30, 60, 90 and 120 minutes

  • Change in body fat percentage

    BIA measurements were recorded for the body fat percentage (%) at baseline, 30, 60, 90, and 120 minutes.

    Baseline and 30, 60, 90, and 120 minutes.

  • Change in fat-free mass

    BIA measurements were recorded for the fat-free mass (kg) at baseline, 30, 60, 90, and 120 minutes.

    Baseline and 30, 60, 90, and 120 minutes.

  • Change in muscle mass

    BIA measurements were recorded for the muscle mass (kg) at baseline, 30, 60, 90, and 120 minutes.

    Baseline and 30, 60, 90, and 120 minutes.

  • Change in total body water

    BIA measurements were recorded for the total body water (kg) at baseline, 30, 60, 90, and 120 minutes.

    Baseline and 30, 60, 90, and 120 minutes.

Secondary Outcomes (2)

  • Change in Body Weight

    Baseline, 30, 60, 90 and 120 minutes

  • Change in Body Mass Index

    Baseline, 30, 60, 90 and 120 minutes

Study Arms (3)

Caffeinated coffee

EXPERIMENTAL

Coffee made with 11 g caffeinated coffee and 200 ml water was given to participants. BIA measurement was done before and after coffee intake every 30 minutes up to 120 minutes.

Other: Caffeinated coffee

Decaffeinated coffee

EXPERIMENTAL

Coffee made with 11 g decaffeinated coffee and 200 ml water was given to participants. BIA measurement was done before and after coffee intake every 30 minutes up to 120 minutes.

Other: Decaffeinated coffee

Water

EXPERIMENTAL

200 ml water was given to participants. BIA measurement was done before and after coffee intake every 30 minutes up to 120 minutes.

Other: Water

Interventions

Caffeinated coffeeOTHER

11 g caffeinated coffee made with 200 ml water was given to participants.

Caffeinated coffee
Decaffeinated coffeeOTHER

11 g decaffeinated coffee made with 200 ml water was given to participants.

Decaffeinated coffee
WaterOTHER

200 ml water was given to participants.

Water

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adults aged ≥18 years.
  • BMI between 18.5 and 29.9 kg/m².
  • Regular coffee consumers.
  • Participants providing written informed consent.

You may not qualify if:

  • Individuals on medication or hormone therapy within the last 6 months.
  • Medical conditions affecting caffeine metabolism (e.g., allergies or intolerances).
  • Chronic or acute diseases.
  • Significant appetite or eating disturbances in the past 6 months.
  • Participants menstruating on the day of analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University, Faculty of Health Sciences

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Guleren Sabuncular, PhD

    Marmara University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 23, 2024

First Posted

January 1, 2025

Study Start

February 25, 2023

Primary Completion

March 25, 2023

Study Completion

May 20, 2023

Last Updated

January 1, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)