Diet HabitsPADESNCT07464899
Body Composition and Lifestyles in Athletes With Disabilities
An observational study of Diet Habits and Body Composition, run by University of Alicante at 1 site in Spain.
Trial summary
Disability involves limitations that affect mobility and the ability to perform daily activities and achieve competitive goals. It is expected that disability has a significant impact on body composition, including reductions in lean mass and bone mineral content, and increases in fat mass and its distribution. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diet Habits, Body Composition, Athlete Assessment
- What is being tested?
- Diet, body composition and Physical activity
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2024to 30 Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Athletes with disabilities from the different sports disciplines that belong to the Spanish Federation of Sports for People with Physical Disabilities (FEDDF), the Spanish Federation of Sports for the Blind (FEDC), and the Spanish Federation of Sports for the Deaf (FEDS).
Who may be able to join
- Acceptation of informed consent
- Have a federation license and at least two years of experience practicing the sport in which they will be classified.
- Follow a training program with a minimum frequency of three days per week.
- Have maintained training continuity for at least one month without absences.
- Any type of disability.
Who cannot join
- No attendance to the evaluations
- Reporting less than 80% of assistance to physical activity sessions reported by trainer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
David Romero García, Dr contact
Spain1 site, 1 recruiting
- Recruiting
Faculty of Health Sciences. University of Alicante
San Vicent del Raspeig, Alicante, 03690
Manuel Fernández Alcántara, Dr, +34965903400 ext. Ext. 2236, mfernandeza@ua.es
About this study
Official title: Anthropometric, Dietary, Exercise, and Supplementation Profile in Athletes With Disabilities (PADES)
Disability involves limitations that affect mobility and the ability to perform daily activities and achieve competitive goals. It is expected that disability has a significant impact on body composition, including reductions in lean mass and bone mineral content, and increases in fat mass and its distribution. Additionally, the assessment of food and dietary supplement intake among athletes with disabilities remains poorly described, despite its relevance in both sports and health contexts due to the potential benefits of individualized nutritional strategies.
This research project, entitled Anthropometric, Dietary, Exercise, and Supplementation Profile in Athletes with Disabilities (PADES), aims to describe the anthropometric characteristics, physical exercise practices, and food and supplement intake in Spanish athletes with disabilities. The study seeks to address the current lack of standardized anthropometric data and the limited information on dietary and supplementation patterns in this population, which hinders a comprehensive understanding of the physiological, nutritional, and biomechanical aspects essential for their health and athletic performance. A cross-sectional, descriptive-correlational study will be conducted in Spanish athletes with disabilities recruited through the Spanish Federation of Sports for People with Physical Disabilities (FEDDF), the Spanish Federation of Sports for the Blind (FEDC), and the Spanish Federation of Sports for the Deaf (FEDS).
Read the detailed description
The field of disability, there is a notable lack of standardized data on anthropometric measurements, physical activity practices, and food and/or supplement intake among athletes with disabilities. This gap limits our understanding of key physiological, nutritional, and biomechanical aspects of this population, making it difficult to generate evidence-based knowledge applicable to their health, athletic performance, and overall well-being. In the absence of specific data, designing personalized and effective nutrition or training programs becomes more challenging and imprecise.
The diversity in types of disabilities, functional classifications, and levels of physical activity demands an evidence-based approach to ensure that interventions are safe, effective, and tailored to the individual needs of athletes. Anthropometric assessment, dietary and supplement intake evaluation, as well as physical activity practices are measurable factors related to the nutritional health status of athletes with disabilities, directly influencing their physical performance and contributing to safer and more effective sports participation.
Establishing reference tables or consumption patterns will allow for comparisons between different types of disabilities and/or functional classes. These comparisons are essential to identify trends and develop targeted intervention strategies that benefit the broader population of athletes with disabilities.
- Conditions
- Diet Habits, Body Composition, Athlete Assessment, Sport Nutrition
- Being tested
- Diet, body composition, Physical activity, health status
- Keywords
- sport nutrition, questionnaries, athletes, dietary-nutritional assessment, body composition, disability
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
frequency of food and supplement consumption
body compositionOther
body composition assessment
Physical activityOther
Physical activity level
health statusOther
perception of health status
| Study group | Role | What they receive |
|---|---|---|
| Male | adult male athletes with disabilities Receives: Other: Diet; Other: body composition; Other: Physical activity; Other: health status | |
| Female | adult female athletes with disabilities Receives: Other: Diet; Other: body composition; Other: Physical activity; Other: health status |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass
Measure: body mass.
Unit of Measure: kilograms (kg).
Description: measured using a SECA 862 scale or SECA 676 wheelchair scale according to the ISAK protocol.
Measured: 4 years
Linear Dimensions (Stature, Girths, Lengths and Breadths)
Measures: stretch stature, sitting height, arm span, girths, lengths and breadths.
Unit of Measure: centimeters (cm).
Description: stretch stature and sitting height will be measured using a SECA 217 stadiometer; arm span will be measured using a Smartmet arm-span device; girths will be measured using an inextensible Smartmet metal tape; breadths will be measured using a Holtain small sliding caliper and a Realmet large sliding caliper; and lengths will be determined using a Smartmet segmometer according to the ISAK protocol.
Measured: 4 years
Skinfolds
Measure: skinfolds (triceps, subscapular, biceps, iliac crest, supraspinale, abdominal, thigh and calf).
Unit of Measure: millimeters (mm).
Description: measured with a Holtain skinfold caliper following the ISAK protocol.
Measured: 4 years
Body Composition Variables
Measures: fat mass, fat-free mass, adipose mass, muscle mass, and bone mass.
Unit of Measure: kilograms (kg).
Description: fat mass will be estimated using the Katch-McArdle (1973) equation, based on body mass and selected skinfolds; fat-free mass will be estimated as the difference between body mass and fat mass; adipose mass will be estimated using the Kerr (1991) equation, based on stretch stature and selected skinfolds; muscle mass will be estimated using the Lee (2000) equation, based on stretch stature and corrected girths; and bone mass will be estimated using the Rocha (1974) equation, based on stretch stature and selected breadths.
Measured: 4 years
Secondary outcomes (3)
Dietary intake assessed using the Food4Me FFQ
A questionnaire validated in terms of content, applicability, structure, and presentation by University College Dublin and Crème Software Ltd. will be used (Food4Me FFQ). It is a self-administered, online, semi-quantitative food frequency questionnaire. It comprises a total of 24 questions divided into two main sections. The first section collects the participant's age, the team they play for (which identifies the participant's sex), and playing position. The second section includes 21 questions assessing the intake of various food and beverage groups over the previous month (average intake of 157 foods). Consumption frequency is assessed by selecting one of the following options: never or less than once per month; 1-3 times per month; once per week; 2-4 times per week; 5-6 times per week; once per day; 2-3 times per day; 5-6 times per day; and >6 times per day.
Measured: 4 years
Supplement consumption assessed using the Sports Supplement Intake Questionnaire
A questionnaire validated using qualitative methodology and self-administered either in person or online will be used. The questionnaire comprises a total of 34 questions divided into three main sections. The first section, comprising 6 questions, collects anthropometric data such as age, body mass, and height; personal data such as sex and date of birth; and sociodemographic information such as the autonomous community of residence. The second section includes 10 questions covering sport participation and its context, including the team/sports club, competition level, years of practice, and training and competition schedules. The final section, consisting of 14 questions, focuses on sports supplement consumption, namely which sports supplements participants consume, why they consume them, who advises them to consume them, where they purchase them, when they take them, and their perceived effects after consumption.
Measured: 4 years
Physical Activity Level assessed using the short form of the International Physical Activity Questionnaire (IPAQ-SF)
The IPAQ-SF comprises 9 items and records the activity of four intensity levels: vigorous-intensity acitivity, moderate-intensity acitivity, walking and sitting. This version does not allow for a detailed assessment of physical activity across each domain of daily life; however, it integrates aspects of all domains, enabling the recording of total time and energy expenditure. Both versions assess three specific characteristics of activity: intensity (light, moderate, or vigorous), frequency (measured in days per week), and duration (time per day).
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start1 Feb 2024
- Primary completion23 Feb 2024
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diet HabitsStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alicante
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Miguel Martinez Sanz, University of Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464899
- Sponsor's protocol ID
- UA-2025-02-14
- Acronym
- PADES
- Status last verified
- Mar 2026
- First submitted
- 5 Aug 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data are available from the authors on request from the IP JMMS (josemiguel.ms@ua.es).
Publications
Flueck JL. Body Composition in Swiss Elite Wheelchair Athletes. Front Nutr. 2020 Jan 22;7:1. doi: 10.3389/fnut.2020.00001. eCollection 2020.
PubMed 32039228Cavedon V, Zancanaro C, Milanese C. Body composition assessment in athletes with physical impairment who have been practicing a wheelchair sport regularly and for a prolonged period. Disabil Health J. 2020 Oct;13(4):100933. doi: 10.1016/j.dhjo.2020.100933. Epub 2020 Apr 22.
PubMed 32402793Bernardi M, Guerra E, Di Giacinto B, Di Cesare A, Castellano V, Bhambhani Y. Field evaluation of paralympic athletes in selected sports: implications for training. Med Sci Sports Exerc. 2010 Jun;42(6):1200-8. doi: 10.1249/MSS.0b013e3181c67d82.
PubMed 19997027Capling L, Beck KL, Gifford JA, Slater G, Flood VM, O'Connor H. Validity of Dietary Assessment in Athletes: A Systematic Review. Nutrients. 2017 Dec 2;9(12):1313. doi: 10.3390/nu9121313.
PubMed 29207495Serafini S, Charrier D, Izzicupo P, Esparza-Ros F, Vaquero-Cristobal R, Petri C, Mecherques-Carini M, Baglietto N, Holway F, Tinsley G, Paoli A, Campa F. Anthropometric-based predictive equations developed with multi-component models for estimating body composition in athletes. Eur J Appl Physiol. 2025 Mar;125(3):595-610. doi: 10.1007/s00421-024-05672-3. Epub 2024 Dec 6.
PubMed 39641837Lachat C, Hawwash D, Ocke MC, Berg C, Forsum E, Hornell A, Larsson C, Sonestedt E, Wirfalt E, Akesson A, Kolsteren P, Byrnes G, De Keyzer W, Van Camp J, Cade JE, Slimani N, Cevallos M, Egger M, Huybrechts I. Strengthening the Reporting of Observational Studies in Epidemiology-Nutritional Epidemiology (STROBE-nut): An Extension of the STROBE Statement. PLoS Med. 2016 Jun 7;13(6):e1002036. doi: 10.1371/journal.pmed.1002036. eCollection 2016 Jun.
PubMed 27270749
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anthropometric, Dietary, Exercise, and Supplementation Profile in Athletes With Disabilities (PADES)
- ClinicalTrials.gov ID
- NCT07464899
- Acronym / sponsor ID
- PADES / UA-2025-02-14
- Conditions
- Diet Habits, Body Composition, Athlete Assessment, Sport Nutrition
- Keywords
- sport nutrition, questionnaries, athletes, dietary-nutritional assessment, body composition, disability
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of AlicanteUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 11 Mar 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.
Disability involves limitations that affect mobility and the ability to perform daily activities and achieve competitive goals. It is expected that disability has a significant impact on body composition, including reductions in lean mass and bone mineral content, and increases in fat mass and its distribution. Additionally, the assessment of food and dietary supplement intake among athletes with disabilities remains poorly described, despite its relevance in both sports and health contexts due to the potential benefits of individualized nutritional strategies.
This research project, entitled Anthropometric, Dietary, Exercise, and Supplementation Profile in Athletes with Disabilities (PADES), aims to describe the anthropometric characteristics, physical exercise practices, and food and supplement intake in Spanish athletes with disabilities. The study seeks to address the current lack of standardized anthropometric data and the limited information on dietary and supplementation patterns in this population, which hinders a comprehensive understanding of the physiological, nutritional, and biomechanical aspects essential for their health and athletic performance. A cross-sectional, descriptive-correlational study will be conducted in Spanish athletes with disabilities recruited through the Spanish Federation of Sports for People with Physical Disabilities (FEDDF), the Spanish Federation of Sports for the Blind (FEDC), and the Spanish Federation of Sports for the Deaf (FEDS).
Detailed description
The field of disability, there is a notable lack of standardized data on anthropometric measurements, physical activity practices, and food and/or supplement intake among athletes with disabilities. This gap limits our understanding of key physiological, nutritional, and biomechanical aspects of this population, making it difficult to generate evidence-based knowledge applicable to their health, athletic performance, and overall well-being. In the absence of specific data, designing personalized and effective nutrition or training programs becomes more challenging and imprecise.
The diversity in types of disabilities, functional classifications, and levels of physical activity demands an evidence-based approach to ensure that interventions are safe, effective, and tailored to the individual needs of athletes. Anthropometric assessment, dietary and supplement intake evaluation, as well as physical activity practices are measurable factors related to the nutritional health status of athletes with disabilities, directly influencing their physical performance and contributing to safer and more effective sports participation.
Establishing reference tables or consumption patterns will allow for comparisons between different types of disabilities and/or functional classes. These comparisons are essential to identify trends and develop targeted intervention strategies that benefit the broader population of athletes with disabilities.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Male | – | Other: Diet, Other: body composition, Other: Physical activity, Other: health statusadult male athletes with disabilities |
| Female | – | Other: Diet, Other: body composition, Other: Physical activity, Other: health statusadult female athletes with disabilities |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Athletes with disabilities from the different sports disciplines that belong to the Spanish Federation of Sports for People with Physical Disabilities (FEDDF), the Spanish Federation of Sports for the Blind (FEDC), and the Spanish Federation of Sports for the Deaf (FEDS).
Key inclusion criteria (5 listed)
- Acceptation of informed consent
- Have a federation license and at least two years of experience practicing the sport in which they will be classified.
- Follow a training program with a minimum frequency of three days per week.
- Have maintained training continuity for at least one month without absences.
- Any type of disability.
Key exclusion criteria (2 listed)
- No attendance to the evaluations
- Reporting less than 80% of assistance to physical activity sessions reported by trainer
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 |
|---|---|---|
| Dietfrequency of food and supplement consumption | Other | Female, Male |
| body compositionbody composition assessment | Other | Female, Male |
| Physical activityPhysical activity level | Other | Female, Male |
| health statusperception of health status | Other | Female, Male |
Primary outcome
Body Mass
Time frame: 4 years
Measure: body mass. Unit of Measure: kilograms (kg). Description: measured using a SECA 862 scale or SECA 676 wheelchair scale according to the ISAK protocol.
Linear Dimensions (Stature, Girths, Lengths and Breadths)
Time frame: 4 years
Measures: stretch stature, sitting height, arm span, girths, lengths and breadths. Unit of Measure: centimeters (cm). Description: stretch stature and sitting height will be measured using a SECA 217 stadiometer; arm span will be measured using a Smartmet arm-span device; girths will be measured using an inextensible Smartmet metal tape; breadths will be measured using a Holtain small sliding caliper and a Realmet large sliding caliper; and lengths will be determined using a Smartmet segmometer according to the ISAK protocol.
Skinfolds
Time frame: 4 years
Measure: skinfolds (triceps, subscapular, biceps, iliac crest, supraspinale, abdominal, thigh and calf). Unit of Measure: millimeters (mm). Description: measured with a Holtain skinfold caliper following the ISAK protocol.
Body Composition Variables
Time frame: 4 years
Measures: fat mass, fat-free mass, adipose mass, muscle mass, and bone mass. Unit of Measure: kilograms (kg). Description: fat mass will be estimated using the Katch-McArdle (1973) equation, based on body mass and selected skinfolds; fat-free mass will be estimated as the difference between body mass and fat mass; adipose mass will be estimated using the Kerr (1991) equation, based on stretch stature and selected skinfolds; muscle mass will be estimated using the Lee (2000) equation, based on stretch stature and corrected girths; and bone mass will be estimated using the Rocha (1974) equation, based on stretch stature and selected breadths.
3 secondary outcomes
Dietary intake assessed using the Food4Me FFQ
Time frame: 4 years
Supplement consumption assessed using the Sports Supplement Intake Questionnaire
Time frame: 4 years
Physical Activity Level assessed using the short form of the International Physical Activity Questionnaire (IPAQ-SF)
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Background: PubMed 32039228Flueck JL. Body Composition in Swiss Elite Wheelchair Athletes. Front Nutr. 2020 Jan 22;7:1. doi: 10.3389/fnut.2020.00001. eCollection 2020.
- Background: PubMed 32402793Cavedon V, Zancanaro C, Milanese C. Body composition assessment in athletes with physical impairment who have been practicing a wheelchair sport regularly and for a prolonged period. Disabil Health J. 2020 Oct;13(4):100933. doi: 10.1016/j.dhjo.2020.100933. Epub 2020 Apr 22.
- Background: PubMed 19997027Bernardi M, Guerra E, Di Giacinto B, Di Cesare A, Castellano V, Bhambhani Y. Field evaluation of paralympic athletes in selected sports: implications for training. Med Sci Sports Exerc. 2010 Jun;42(6):1200-8. doi: 10.1249/MSS.0b013e3181c67d82.
- Background: PubMed 29207495Capling L, Beck KL, Gifford JA, Slater G, Flood VM, O'Connor H. Validity of Dietary Assessment in Athletes: A Systematic Review. Nutrients. 2017 Dec 2;9(12):1313. doi: 10.3390/nu9121313.
- Background: PubMed 39641837Serafini S, Charrier D, Izzicupo P, Esparza-Ros F, Vaquero-Cristobal R, Petri C, Mecherques-Carini M, Baglietto N, Holway F, Tinsley G, Paoli A, Campa F. Anthropometric-based predictive equations developed with multi-component models for estimating body composition in athletes. Eur J Appl Physiol. 2025 Mar;125(3):595-610. doi: 10.1007/s00421-024-05672-3. Epub 2024 Dec 6.
- Background: PubMed 27270749Lachat C, Hawwash D, Ocke MC, Berg C, Forsum E, Hornell A, Larsson C, Sonestedt E, Wirfalt E, Akesson A, Kolsteren P, Byrnes G, De Keyzer W, Van Camp J, Cade JE, Slimani N, Cevallos M, Egger M, Huybrechts I. Strengthening the Reporting of Observational Studies in Epidemiology-Nutritional Epidemiology (STROBE-nut): An Extension of the STROBE Statement. PLoS Med. 2016 Jun 7;13(6):e1002036. doi: 10.1371/journal.pmed.1002036. eCollection 2016 Jun.
- Individual participant dataSharing planned: No. The data are available from the authors on request from the IP JMMS (josemiguel.ms@ua.es).
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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.
David Romero García, Dr contact
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 Diet Habits and Body Composition, run by University of Alicante at 1 site in Spain.
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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 11 Mar 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jose Miguel Martinez Sanz, Dr (+34 620420726, josemiguel.ms@ua.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass (time frame: 4 years). The study lists 4 primary outcomes in all. 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 NCT07464899, which also lists 6 linked publications.
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 11 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.