- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06754748
Acute Effects of Caffeinated and Decaffeinated Coffee on Bioelectrical Impedance Analysis
Investigating the Acute Impacts of Caffeinated Coffee, Decaffeinated Coffee, and Water on Body Composition Parameters Measured Via Bioelectrical Impedance Analysis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study aims to address these gaps by examining how caffeinated coffee, decaffeinated coffee, and water influence BIA measurements at multiple intervals post-consumption (baseline, 30, 60, 90, and 120 minutes). By incorporating a controlled study design with separate water-only and caffeine-free groups, this methodology overcomes the limitations of previous studies that lacked comprehensive control conditions. By determining whether caffeine or fluid volume primarily drives changes in BIA parameters and identifying the timing of these effects, this research seeks to improve the understanding of external factors affecting BIA, providing valuable insights for accurate body composition assessments.
Participants were divided into three groups based on their average daily caffeine consumption: caffeinated coffee, decaffeinated coffee, and water.
To standardize caffeine and fluid intake, filter coffee was chosen for its consistency in caffeine content and fluid volume. Both caffeinated and decaffeinated Arabic coffee were prepared using 11 g of coffee per 200 ml of water. The coffee was weighed using a precision balance and brewed with a filter coffee machine to ensure uniform preparation.
Participants were instructed to adhere to the following restrictions prior to the analysis day: a 12-hour fast, avoidance of excessive fluids, abstinence from caffeine-containing beverages, no showering or sauna use, no alcohol consumption for 48 hours, and no heavy exercise for 4-12 hours before the measurement. These restrictions minimized potential confounding effects on hydration or metabolic state, ensuring reliable BIA measurements.
The first BIA measurements were taken before any beverage consumption. Subsequently, participants consumed 200 ml of caffeinated coffee, decaffeinated coffee, or water, depending on their group. BIA measurements were repeated at 30, 60, 90, and 120 minutes post-consumption.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maltepe
-
Istanbul, Maltepe, Turkey, 34854
- Marmara University, Faculty of Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy adults aged ≥18 years.
- BMI between 18.5 and 29.9 kg/m².
- Regular coffee consumers.
- Participants providing written informed consent.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Caffeinated coffee
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.
|
11 g caffeinated coffee made with 200 ml water was given to participants.
|
|
Experimental: Decaffeinated coffee
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.
|
11 g decaffeinated coffee made with 200 ml water was given to participants.
|
|
Experimental: Water
200 ml water was given to participants.
BIA measurement was done before and after coffee intake every 30 minutes up to 120 minutes.
|
200 ml water was given to participants.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Body Fat Mass
Time Frame: Baseline, 30, 60, 90 and 120 minutes
|
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
Time Frame: Baseline and 30, 60, 90, and 120 minutes.
|
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
Time Frame: Baseline and 30, 60, 90, and 120 minutes.
|
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
Time Frame: Baseline and 30, 60, 90, and 120 minutes.
|
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
Time Frame: Baseline and 30, 60, 90, and 120 minutes.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Body Weight
Time Frame: Baseline, 30, 60, 90 and 120 minutes
|
Body weight (kg) was measured with BIA at baseline, 30, 60, 90 and 120 minutes and recorded.
|
Baseline, 30, 60, 90 and 120 minutes
|
|
Change in Body Mass Index
Time Frame: Baseline, 30, 60, 90 and 120 minutes
|
Body mass index was calculated from weight and height and presented as kg/m² at baseline, 30, 60, 90 and 120 minutes and recorded.
|
Baseline, 30, 60, 90 and 120 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Guleren Sabuncular, PhD, Marmara University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- GS_1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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