Body Weight ChangesNCT04429581
Differences in Fat Mass Estimation Formulas in Physically Active Adult Population and Relation With Skinfold Sums.
An observational study of Body Weight Changes and Body Weight, run by Universidad Católica San Antonio de Murcia.
Trial summary
The objective of the present study was to analyze the differences between the formulas used to estimate fat mass and to establish the existing relationship with the skinfold sum in anthropometry. A total of 2,458 active subjects participated in the study (mean age: 27.98±7.43 years-old). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight Changes, Body Weight
- What is being tested?
- Anthropometry
- How many people
- 2,458 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2013to 20 Jun 2019
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The present study was conducted with a sample of 2,458 active subjects (mean age: 27,98±7,43 year-old), 1775 men (mean age: 27,99±7,46 years) and 681 women (mean age: 27,94±7,37 years) from Región de Murcia (Spain)
Who may be able to join
- To be between 18 and 50 years old and to practice any sport in a regular basis
Who cannot join
- To have overweight or obesity
About this study
The objective of the present study was to analyze the differences between the formulas used to estimate fat mass and to establish the existing relationship with the skinfold sum in anthropometry. A total of 2,458 active subjects participated in the study (mean age: 27.98±7.43 years-old). Basic measurements and skinfolds variables were measured following the guidelines of the International Society for the Advancement in Kinanthropometry (ISAK), and Kerr, Durnin-Womersley, Faulkner and Carter equations were used to assess fat mass. Significative differences were found between all the formulas for the percentage of fat mass and the fat mass in kilograms. The correlations among the skinfolds sums and the different equations were high and significative in all the cases. There were differences between all the formulas used to estimate the fat mass. The six or eight skinfold sums could be a valid and better alternative than the fat mass equations or the BMI to assess the subcutaneous fat mass in physically active adults.
- Conditions
- Body Weight Changes, Body Weight
- Being tested
- Anthropometry
- Keywords
- Fat mass, Body composition assessement, Health, Antropometry
- Medical subject headings
- Body Weight Changes, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnthropometryOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat mass weight
Fat mass weight was assessed with skinfold measurements and different prediction equations. Measured in kilograms
Measured: 6 years
Fat mass percentage
Fat mass percentage was assessed with skinfold measurements and different prediction equations. Measured in percentage of total weight.
Measured: 6 years
Six and eight skinfold sums
Skinfolds were measured with a caliper, using anthropometry technique describes by ISAK
Measured: 6 years
Secondary outcomes (3)
Body Mass Index
Weight and height will be combined to report BMI in kg/m^2
Measured: 6 years
Weight
Measured in kilograms
Measured: 6 years
Height
Measured in meters
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start2 Feb 2013
- Primary completion20 Jun 2019
- Study completion20 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Weight ChangesStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 2,458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Esparza Ros, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429581
- Sponsor's protocol ID
- 23/02/2013
- Status last verified
- Jun 2020
- First submitted
- 5 Jun 2020
- Last updated
- 12 Jun 2020
- 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 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Fat Mass Estimation Formulas in Physically Active Adult Population and Relation With Skinfold Sums.
- ClinicalTrials.gov ID
- NCT04429581
- Acronym / sponsor ID
- 23/02/2013
- Conditions
- Body Weight Changes, Body Weight
- Keywords
- Fat mass, Body composition assessement, Health, Antropometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,458 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 2 Feb 2013 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 12 Jun 2020 (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.
The objective of the present study was to analyze the differences between the formulas used to estimate fat mass and to establish the existing relationship with the skinfold sum in anthropometry. A total of 2,458 active subjects participated in the study (mean age: 27.98±7.43 years-old). Basic measurements and skinfolds variables were measured following the guidelines of the International Society for the Advancement in Kinanthropometry (ISAK), and Kerr, Durnin-Womersley, Faulkner and Carter equations were used to assess fat mass. Significative differences were found between all the formulas for the percentage of fat mass and the fat mass in kilograms. The correlations among the skinfolds sums and the different equations were high and significative in all the cases. There were differences between all the formulas used to estimate the fat mass. The six or eight skinfold sums could be a valid and better alternative than the fat mass equations or the BMI to assess the subcutaneous fat mass in physically active adults.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The present study was conducted with a sample of 2,458 active subjects (mean age: 27,98±7,43 year-old), 1775 men (mean age: 27,99±7,46 years) and 681 women (mean age: 27,94±7,37 years) from Región de Murcia (Spain)
Key inclusion criteria (1 listed)
- To be between 18 and 50 years old and to practice any sport in a regular basis
Key exclusion criteria (1 listed)
- To have overweight or obesity
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 |
|---|---|---|
| Anthropometry | Other | – |
Primary outcome
Fat mass weight
Time frame: 6 years
Fat mass weight was assessed with skinfold measurements and different prediction equations. Measured in kilograms
Fat mass percentage
Time frame: 6 years
Fat mass percentage was assessed with skinfold measurements and different prediction equations. Measured in percentage of total weight.
Six and eight skinfold sums
Time frame: 6 years
Skinfolds were measured with a caliper, using anthropometry technique describes by ISAK
3 secondary outcomes
Body Mass Index
Time frame: 6 years
Weight
Time frame: 6 years
Height
Time frame: 6 years
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 12 Jun 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Weight Changes and Body Weight, run by Universidad Católica San Antonio de Murcia.
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 1 inclusion and 1 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 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Fat mass weight (time frame: 6 years). The study lists 3 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 12 Jun 2020.