Body WaterNCT07760753
Age and Body Water Distribution: A Bioimpedance Study
An observational study of Body Water and Aging, run by Medical University of Silesia at 1 site in Poland.
Trial summary
This study examines how body water distribution changes with age. Using a non-invasive body composition device (bioelectrical impedance analysis), researchers measured the amount of water inside and outside the body's cells, both for the whole body and separately for the arms, trunk, and legs, in adults aged 18 to 83. Read more about this study
- Who is it for?
- Ages 18 to 83 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Water, Aging
- How many people
- 568 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2013to Dec 2017
- Phase
- Observational
- 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 to 83 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers recruited between the beginning of 2013 and the end of 2017 from among students and employees of the Medical University of Silesia (Katowice, Poland), and their families and friends.
Who may be able to join
- Adults aged 18 years or older
- Completion of the study participation agreement (informed consent)
- General good health
Who cannot join
- Pregnancy
- Presence of a cardiac pacemaker or other implanted electronic medical device
- Presence of metal implants contraindicating bioelectrical impedance analysis
- Inability to stand or maintain the position required for measurement
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Basic Biomedical Science, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical University of Silesia, Katowice, Poland
Sosnowiec, 41--200
About this study
Official title: Age-Related Changes in Whole-Body and Segmental Extracellular-to-Total Body Water Ratio: A Cross-Sectional Bioelectrical Impedance Analysis Study
This study examines how body water distribution changes with age. Using a non-invasive body composition device (bioelectrical impedance analysis), researchers measured the amount of water inside and outside the body's cells, both for the whole body and separately for the arms, trunk, and legs, in adults aged 18 to 83. The study explores whether the balance between water inside and outside cells shifts as people get older, independent of their body weight, and whether this pattern differs between men and women or between different parts of the body.
Read the detailed description
This is a retrospectively registered, cross-sectional observational study based on body composition data collected using a bioelectrical impedance analyzer (InBody S10; BioSpace, Seoul, Republic of Korea). Whole-body and segmental (right arm, left arm, trunk, right leg, left leg) measures of intracellular water (ICW), extracellular water (ECW), total body water (TBW), and the ECW/TBW ratio were obtained. The primary aim is to characterize the relationship between age and the ECW/TBW ratio, a marker of cellular hydration status, both overall and after adjusting for body mass index (BMI). Secondary aims include evaluating whether this relationship differs by body segment, by sex, and whether it is better explained by body fat percentage or muscle mass than by BMI. Left-right asymmetry in segmental water and lean mass was also assessed.
- Conditions
- Body Water, Aging
- Keywords
- bioelectrical impedance analysis, extracellular water, intracellular water, ECW/TBW ratio, segmental body composition, cellular hydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults undergoing bioimpedance body composition analysis | Adult participants aged 18-83 years who underwent whole-body and segmental bioelectrical impedance analysis (InBody S10) as part of a single, non-interventional assessment of body water distribution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-Body ECW/TBW Ratio in Relation to Age
The extracellular-to-total body water ratio (ECW/TBW), a marker of cellular hydration status, was measured for the whole body using bioelectrical impedance analysis (InBody S10). Values were correlated with participant age, both unadjusted and adjusted for body mass index, to assess whether cellular hydration status changes with age independently of body mass.
Measured: At enrollment
Secondary outcomes (9)
Segmental ECW/TBW Ratio in Relation to Age
The extracellular-to-total body water ratio (ECW/TBW) was additionally calculated separately for five body segments (right arm, left arm, trunk, right leg, left leg) using bioelectrical impedance analysis. Correlations with age were assessed for each segment individually, unadjusted and adjusted for body mass index (BMI), to determine whether the age-related increase in extracellular water proportion is uniform across body regions or differs by segment.
Measured: At enrollment
Right-Left Difference in Segmental Water Content
Right-minus-left differences in segmental water content (kg) were calculated for the arm pair and the leg pair. Paired comparisons were used to assess whether these differences deviate significantly from zero, separately for men and women.
Measured: At enrollment
Right-Left Difference in Segmental Lean Mass
Right-minus-left differences in segmental lean (fat-free) mass (kg) were calculated for the arm pair and the leg pair. Paired comparisons were used to assess whether these differences deviate significantly from zero, separately for men and women.
Measured: At enrollment
Whole-Body Intracellular Water (ICW) in Relation to Age and Body Weight
Intracellular water (liters) was correlated with participant age and with body weight/BMI, to characterize the determinants of this water compartment and to contrast them with the determinants of the ECW/TBW ratio.
Measured: At enrollment
Whole-Body Extracellular Water (ECW) in Relation to Age and Body Weight
Extracellular water (liters) was correlated with participant age and with body weight/BMI, to characterize the determinants of this water compartment and to contrast them with the determinants of the ECW/TBW ratio.
Measured: At enrollment
Whole-Body Total Body Water (TBW) in Relation to Age and Body Weight
Total body water (liters), the sum of intracellular and extracellular water, was correlated with participant age and with body weight/BMI, to characterize the determinants of absolute water volume as distinct from the determinants of the ECW/TBW ratio.
Measured: At enrollment
ECW/TBW Ratio in Relation to BMI
The association between the whole-body extracellular-to-total body water ratio (ECW/TBW) and body mass index (BMI) was assessed, to evaluate BMI as a potential correlate of cellular hydration status.
Measured: At enrollment
ECW/TBW Ratio in Relation to Percent Body Fat
The association between the whole-body extracellular-to-total body water ratio (ECW/TBW) and percent body fat (PBF), derived from bioelectrical impedance analysis, was assessed as an alternative body composition correlate to body mass index (BMI).
Measured: At enrollment
ECW/TBW Ratio in Relation to Skeletal Muscle Mass
The association between the whole-body extracellular-to-total body water ratio (ECW/TBW) and skeletal muscle mass (SMM), derived from bioelectrical impedance analysis, was assessed as an alternative body composition correlate to body mass index (BMI).
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study startJan 2013
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body WaterStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 568 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara Błońska-Fajfrowska, Prof, Principal investigator, Medical University of Silesia, Katowice, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760753
- Sponsor's protocol ID
- KNW/0022/KB1/49/13
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing was not part of the original study protocol, which began enrollment in 2013, predating the International Committee of Medical Journal Editors (ICMJE) requirement for data sharing statements (applicable to trials enrolling participants from January 1, 2019 onward). The dataset has been and will continue to be used by the same research team for related analyses reported in separate publications. De-identified data may be made available from the corresponding author upon reasonable request.
Publications
Lebiedowska A, Hartman-Petrycka M, Blonska-Fajfrowska B. How reliable is BMI? Bioimpedance analysis of body composition in underweight, normal weight, overweight, and obese women. Ir J Med Sci. 2021 Aug;190(3):993-998. doi: 10.1007/s11845-020-02403-3. Epub 2020 Oct 21.
PubMed 33083960
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-Related Changes in Whole-Body and Segmental Extracellular-to-Total Body Water Ratio: A Cross-Sectional Bioelectrical Impedance Analysis Study
- ClinicalTrials.gov ID
- NCT07760753
- Acronym / sponsor ID
- KNW/0022/KB1/49/13
- Conditions
- Body Water, Aging
- Keywords
- bioelectrical impedance analysis, extracellular water, intracellular water, ECW/TBW ratio, segmental body composition, cellular hydration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 568 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 12 Aug 2026 (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 examines how body water distribution changes with age. Using a non-invasive body composition device (bioelectrical impedance analysis), researchers measured the amount of water inside and outside the body's cells, both for the whole body and separately for the arms, trunk, and legs, in adults aged 18 to 83. The study explores whether the balance between water inside and outside cells shifts as people get older, independent of their body weight, and whether this pattern differs between men and women or between different parts of the body.
Detailed description
This is a retrospectively registered, cross-sectional observational study based on body composition data collected using a bioelectrical impedance analyzer (InBody S10; BioSpace, Seoul, Republic of Korea). Whole-body and segmental (right arm, left arm, trunk, right leg, left leg) measures of intracellular water (ICW), extracellular water (ECW), total body water (TBW), and the ECW/TBW ratio were obtained. The primary aim is to characterize the relationship between age and the ECW/TBW ratio, a marker of cellular hydration status, both overall and after adjusting for body mass index (BMI). Secondary aims include evaluating whether this relationship differs by body segment, by sex, and whether it is better explained by body fat percentage or muscle mass than by BMI. Left-right asymmetry in segmental water and lean mass was also assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults undergoing bioimpedance body composition analysis | – | –Adult participants aged 18-83 years who underwent whole-body and segmental bioelectrical impedance analysis (InBody S10) as part of a single, non-interventional assessment of body water distribution. |
Who may qualify
- Ages
- 18 to 83 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers recruited between the beginning of 2013 and the end of 2017 from among students and employees of the Medical University of Silesia (Katowice, Poland), and their families and friends.
Key inclusion criteria (3 listed)
- Adults aged 18 years or older
- Completion of the study participation agreement (informed consent)
- General good health
Key exclusion criteria (4 listed)
- Pregnancy
- Presence of a cardiac pacemaker or other implanted electronic medical device
- Presence of metal implants contraindicating bioelectrical impedance analysis
- Inability to stand or maintain the position required for measurement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Whole-Body ECW/TBW Ratio in Relation to Age
Time frame: At enrollment
The extracellular-to-total body water ratio (ECW/TBW), a marker of cellular hydration status, was measured for the whole body using bioelectrical impedance analysis (InBody S10). Values were correlated with participant age, both unadjusted and adjusted for body mass index, to assess whether cellular hydration status changes with age independently of body mass.
9 secondary outcomes
Segmental ECW/TBW Ratio in Relation to Age
Time frame: At enrollment
Right-Left Difference in Segmental Water Content
Time frame: At enrollment
Right-Left Difference in Segmental Lean Mass
Time frame: At enrollment
Whole-Body Intracellular Water (ICW) in Relation to Age and Body Weight
Time frame: At enrollment
Whole-Body Extracellular Water (ECW) in Relation to Age and Body Weight
Time frame: At enrollment
Whole-Body Total Body Water (TBW) in Relation to Age and Body Weight
Time frame: At enrollment
ECW/TBW Ratio in Relation to BMI
Time frame: At enrollment
ECW/TBW Ratio in Relation to Percent Body Fat
Time frame: At enrollment
ECW/TBW Ratio in Relation to Skeletal Muscle Mass
Time frame: At enrollment
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 17 Sep 2026.
- Results publication: PubMed 33083960Lebiedowska A, Hartman-Petrycka M, Blonska-Fajfrowska B. How reliable is BMI? Bioimpedance analysis of body composition in underweight, normal weight, overweight, and obese women. Ir J Med Sci. 2021 Aug;190(3):993-998. doi: 10.1007/s11845-020-02403-3. Epub 2020 Oct 21.
- Individual participant dataSharing planned: No. Data sharing was not part of the original study protocol, which began enrollment in 2013, predating the International Committee of Medical Journal Editors (ICMJE) requirement for data sharing statements (applicable to trials enrolling participants from January 1, 2019 onward). The dataset has been and will continue to be used by the same research team for related analyses reported in separate publications. De-identified data may be made available from the corresponding author upon reasonable request.
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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.
Barbara Błońska-Fajfrowska, Prof principal investigator
Medical University of Silesia, Katowice, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Water and Aging, run by Medical University of Silesia at 1 site in Poland.
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 3 inclusion and 4 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 17 Sep 2026. 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 Poland. 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?
Whole-Body ECW/TBW Ratio in Relation to Age (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07760753, which also lists 1 linked publication.
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 17 Sep 2026.