- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07598786
Development and Strategic Research of Practical Applications in Sports Nutrition
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
With increasing awareness of regular exercise and health promotion, sports nutrition products have become a common supplementation choice among physically active populations. In real-world settings, these products are typically consumed continuously as part of daily life. Evaluating changes in physical status, functional physical performance, and users' subjective perceptions during actual use therefore requires research designs that closely reflect everyday living conditions.
This study recruits physically active adults aged 18-39 years and conducts an 8-week intervention involving the consumption of a dairy product enriched with high protein, calcium, and vitamin D. A pre-, mid-, and post-intervention design is employed, integrating subjective perception questionnaires, body composition analysis, and functional physical performance assessments to evaluate changes in physical status, functional capacity, and subjective experiences throughout the intervention period. Through this multi-dimensional evaluation approach, the study aims to examine the practical feasibility and application value of the product in real-life settings and to provide evidence to support sports nutrition practice and future research.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Yi-Ju Hsu
- Numero di telefono: +886-3-328-3201 #2430
- Email: ruby780202@ntsu.edu.tw
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Aged 18-39 years.
- Have regular exercise habits, defined as exercising at least three times per week, with each session lasting no less than 30 minutes. Exercise intensity should reach a heart rate of approximately ≥130 beats/min or a perceived intensity characterized by noticeable breathlessness and sweating.
- Preferably, at least one exercise session per week should include resistance training.
- Participants must be able to consume dairy products and have no lactose intolerance.
Exclusion Criteria:
- Individuals with lactose intolerance or an allergy to dairy products.
- Individuals who are pregnant, planning to become pregnant, or breastfeeding.
- Individuals with a smoking habit.
- Individuals diagnosed by a physician with cardiovascular disease, hypertension, metabolic disease, asthma, or kidney disease.
- Individuals with a body mass index (BMI) ≥27.
- Individuals who have experienced limb or neuromuscular exercise-related injuries within the past 6 months that prevent them from engaging in regular exercise.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Dairy intervention group
An 8-week high-protein, high-calcium, and vitamin D-enriched dairy intervention.
|
An 8-week high-protein, high-calcium, and vitamin D-enriched dairy intervention.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Questionnaire-based subjective assessment
Lasso di tempo: The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
|
Participants' subjective physical sensations, post-exercise fatigue, body image perceptions, and product use experience will be assessed using individual items from a self-administered questionnaire developed for this study.
Questionnaire items may include Likert-scale items, categorical response options, and open-ended responses.
Likert-scale items will be reported separately according to their original response scale, with the minimum and maximum values specified for each item.
Categorical items will be reported as the number and percentage of participants selecting each response option.
Open-ended responses will be summarized descriptively.
No overall questionnaire total score will be calculated.
|
The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
|
|
Handgrip Strength Test
Lasso di tempo: The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
|
Participants performed the test in a standing position with their arms naturally hanging down.
They held the handgrip dynamometer with one hand and applied maximal force continuously for at least 3 seconds.
Each hand was tested three times, and the best value was recorded.
|
The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
|
|
Push-Up Test
Lasso di tempo: The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
|
Participants performed the push-up test on an exercise mat, with both hands placed shoulder-width apart to support the body.
The fingers pointed forward, the elbows were fully extended, and the feet were approximately 10 cm apart.
Male participants performed the test with support from the feet, whereas female participants performed the modified version with support from the knees.
Participants were instructed to complete as many repetitions as possible while maintaining proper form.
The test was terminated when the movement no longer met the required standard or could not be continued.
|
The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
|
|
Curl-Up Test
Lasso di tempo: The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
|
Participants lay supine on an exercise mat with both knees bent and feet flat on the floor. They performed curl-ups according to a fixed rhythm. Participants were instructed to complete as many repetitions as possible while maintaining proper form. When a participant failed to perform the movement correctly once, the examiner raised one hand and indicated the number "one." If the participant failed a second time, the examiner indicated the number "two." The test was terminated when the participant failed twice or completed 75 repetitions. If the participant was unable to maintain the required rhythm or perform the movement according to the standard criteria, the test was stopped. |
The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
|
|
Three-Minute Progressive Step-in-Place Test
Lasso di tempo: The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
|
Participants performed step-in-place movements according to the instructions and raised their knees to the designated height. The test lasted for 3 minutes, with an initial cadence of 96 beats per minute, which was progressively increased each minute. During the test, heart rate was recorded using a heart rate monitor before exercise, during exercise, and during the post-exercise recovery period. |
The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Body weight
Lasso di tempo: The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
|
Body weight will be measured using the InBody 570 bioelectrical impedance analyzer (InBody, Seoul, South Korea) and reported in kilograms (kg).
|
The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
|
|
Body mass index
Lasso di tempo: The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
|
Body mass index (BMI) will be calculated from body weight and height and reported in kilograms per square meter (kg/m^2).
|
The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
|
|
Body fat percentage
Lasso di tempo: The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
|
Body fat percentage will be measured using the InBody 570 bioelectrical impedance analyzer (InBody, Seoul, South Korea) and reported as a percentage (%).
|
The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
|
|
Fat mass
Lasso di tempo: The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
|
Fat mass will be measured using the InBody 570 bioelectrical impedance analyzer (InBody, Seoul, South Korea) and reported in kilograms (kg).
|
The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
|
|
Skeletal muscle mass
Lasso di tempo: The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
|
Skeletal muscle mass will be measured using the InBody 570 bioelectrical impedance analyzer (InBody, Seoul, South Korea) and reported in kilograms (kg).
|
The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
|
|
Skeletal muscle percentage
Lasso di tempo: The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
|
Skeletal muscle percentage will be measured using the InBody 570 bioelectrical impedance analyzer (InBody, Seoul, South Korea) and reported as a percentage (%).
|
The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
|
|
Waist-to-hip ratio
Lasso di tempo: The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
|
Waist-to-hip ratio will be measured using the InBody 570 bioelectrical impedance analyzer (InBody, Seoul, South Korea) and reported as a ratio.
|
The testing time points are set as follows: before the intervention, after 4 weeks of intervention, and after 8 weeks of intervention.
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Yi-Ju Hsu, Professor, National Taiwan Sport University
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- NTSUIRB-115-010
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Dairy intervention
-
University of ZurichETH Zurich (Switzerland)Reclutamento
-
Oregon Health and Science UniversityNational Institute of Mental Health (NIMH); University of Connecticut; University... e altri collaboratoriNon ancora reclutamento
-
Superior UniversityAttivo, non reclutanteArtrosi al ginocchioPakistan
-
KK Women's and Children's HospitalCompletatoCambio di pesoSingapore
-
Ege Miray TopcuCompletatoAnsia | Terapia di supporto gestita da infermiere | Interventi infermieristiciTurchia (Türkiye)
-
Johns Hopkins UniversityNational Institute on Minority Health and Health Disparities (NIMHD); American...ReclutamentoIpertensione | Ipertensione complicata con il diabete di tipo 2Stati Uniti
-
UNC Lineberger Comprehensive Cancer CenterNational Cancer Institute (NCI); Virginia Commonwealth UniversityReclutamentoObesità | Cancro | Attività fisica | Dieta | Sopravvivenza al cancroStati Uniti
-
University of PittsburghCompletatoDistrofia muscolare di DuchenneStati Uniti
-
University of AarhusIscrizione su invito
-
PeriPharmNon ancora reclutamentoEczema | Dermatite atopica | Caregiver | Fardello | Eczema Dermatite Atopica