Body Composition MeasurementNCT06754748
Acute Effects of Caffeinated and Decaffeinated Coffee on Bioelectrical Impedance Analysis
A study testing Caffeinated coffee, Decaffeinated coffee and Water in people with Body Composition Measurement, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Composition Measurement
- What is being tested?
- Caffeinated coffee, Decaffeinated coffee and Water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2023to 20 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults aged ≥18 years.
- BMI between 18.5 and 29.9 kg/m².
- Regular coffee consumers.
- Participants providing written informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University, Faculty of Health Sciences
Istanbul, Maltepe, 34854
About this study
Official title: Investigating the Acute Impacts of Caffeinated Coffee, Decaffeinated Coffee, and Water on Body Composition Parameters Measured Via Bioelectrical Impedance Analysis
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.
Read the 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.
- Conditions
- Body Composition Measurement
- Being tested
- Caffeinated coffee, Decaffeinated coffee, Water
- Keywords
- Bioelectrical Impedance Analysis, Caffeine, Hydration, Body Composition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeinated coffeeOther
11 g caffeinated coffee made with 200 ml water was given to participants.
Decaffeinated coffeeOther
11 g decaffeinated coffee made with 200 ml water was given to participants.
WaterOther
200 ml water was given to participants.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Fat Mass
BIA measurements were recorded for the body fat mass (kg) at baseline, 30, 60, 90, and 120 minutes.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 30, 60, 90, and 120 minutes.
Secondary outcomes (2)
Change in Body Weight
Body weight (kg) was measured with BIA at baseline, 30, 60, 90 and 120 minutes and recorded.
Measured: Baseline, 30, 60, 90 and 120 minutes
Change in Body Mass Index
Body mass index was calculated from weight and height and presented as kg/m² at baseline, 30, 60, 90 and 120 minutes and recorded.
Measured: Baseline, 30, 60, 90 and 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start25 Feb 2023
- Primary completion25 Mar 2023
- Study completion20 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Composition MeasurementStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guleren Sabuncular, Marmara University
- Investigators
- Guleren Sabuncular, PhD, Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754748
- Sponsor's protocol ID
- GS_1
- Status last verified
- Dec 2024
- First submitted
- 23 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Acute Impacts of Caffeinated Coffee, Decaffeinated Coffee, and Water on Body Composition Parameters Measured Via Bioelectrical Impedance Analysis
- ClinicalTrials.gov ID
- NCT06754748
- Acronym / sponsor ID
- GS_1
- Conditions
- Body Composition Measurement
- Keywords
- Bioelectrical Impedance Analysis, Caffeine, Hydration, Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 25 Feb 2023 (actual)
- Primary completion
- 25 Mar 2023 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Caffeinated coffee | Experimental | Other: Caffeinated coffeeCoffee 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. |
| Decaffeinated coffee | Experimental | Other: Decaffeinated coffeeCoffee 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. |
| Water | Experimental | Other: Water200 ml water was given to participants. BIA measurement was done before and after coffee intake every 30 minutes up to 120 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy adults aged ≥18 years.
- BMI between 18.5 and 29.9 kg/m².
- Regular coffee consumers.
- Participants providing written informed consent.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeinated coffee11 g caffeinated coffee made with 200 ml water was given to participants. | Other | Caffeinated coffee |
| Decaffeinated coffee11 g decaffeinated coffee made with 200 ml water was given to participants. | Other | Decaffeinated coffee |
| Water200 ml water was given to participants. | Other | Water |
Primary outcome
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.
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.
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.
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.
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.
2 secondary outcomes
Change in Body Weight
Time frame: Baseline, 30, 60, 90 and 120 minutes
Change in Body Mass Index
Time frame: Baseline, 30, 60, 90 and 120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Body Composition Measurement
RecruitingObservational study
Multimodal Assessment of Sarcopenia Using Shear Wave Elastography, Dual-Energy X-ray Absorptiometry, Bioelectrical Impedance Analysis, and Physical Performance Measures
Sacropenia
Recruiting
How a Mediterranean Diet With Potatoes Impacts Heart and Metabolic Health in Adults With Pre-Diabetes
Prediabetes, Lipid Profile
RecruitingObservational study
100-Year Human Aging Study
Aging, Aging Well
Recruiting
Wild Blueberries for Gut, Brain, and Heart Health in Adults With High Blood Pressure
Hypertension (Without Type 2 Diabetes Mellitus), High Blood Pressure
Active, not recruitingObservational study
A Multifaceted Assessment of Eating Behaviors, Anthropometric Measurements and Body Composition in Pediatric Patients With Drug-resistant Epilepsy on a Ketogenic Diet and Healthy Children
Epilepsy Intractable
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guleren Sabuncular, PhD study director
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeinated coffee, Decaffeinated coffee and Water in people with Body Composition Measurement, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Fat Mass (time frame: Baseline, 30, 60, 90 and 120 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2025.