- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07569770
Comparing High-Protein and Low-Protein Multi-Ingredient Supplements for Body Composition and Performance in Elite Rugby Players
Comparison of High and Low Protein Dose With Multi-ingredient Supplementation for Body Composition and Exercise Performance in Elite Rugby Players
The purpose of this 12-week study is to compare the effects of two different post-exercise nutritional supplements on the body composition and exercise performance of elite male university rugby players. Athletes often consume very high amounts of protein to build muscle and recover, but excessive protein intake might pose potential health risks.
Study Hypothesis:
The researchers hypothesize that a multi-ingredient supplement with a lower total protein content (about 20 grams) will yield comparable or even superior improvements in body composition and physical performance compared to a standard high-dose whey protein supplement (40 grams).
Study Design:
Twenty elite male college rugby players will be randomly divided into two equal groups. One group will receive the high-dose whey protein, while the other group will receive the lower-dose multi-ingredient supplement (which includes protein, leucine, creatine, red amaranth, and elderberry). Participants will consume their assigned supplement immediately after their training sessions, four times a week for 12 weeks.
Assessments:
Before and after the 12-week intervention, the researchers will measure the participants' body composition (muscle and fat mass), maximum muscle strength, power, agility, and aerobic endurance. The overall goal is to determine if athletes can achieve optimal performance and muscle growth with a lower, more efficient protein intake strategy.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Taipei, Taiwan, 111036
- Institute of Sports Sciences, University of Taipei
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Elite rugby athletes in the university team
- No consumption of performance-enhancing supplements (e.g., creatine, protein supplements, or anabolic-androgenic steroids) one month prior to the study
- No current medication or major musculoskeletal injuries
Exclusion Criteria:
- Vegetarianism
- Whey protein allergy
- Body weight fluctuation of more than 10 kg in the past three months
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: High Protein Group
|
Participants consume 40 g of Whey Protein Concentrate (WPC-80), providing 166 kcal, 32 g of protein, 5 g of carbohydrate, and 2 g of fat per serving.
It is consumed immediately after training, four times per week for 12 weeks.
|
|
Eksperimentel: Low Protein Multi-Ingredient Group
|
Participants consume a single, pre-mixed formulated supplement powder containing approximately 20 g of protein (whey protein fortified with additional leucine and glycine), 30 g of carbohydrates, creatine, red amaranth extract, and elderberry extract (169 kcal).
It is consumed immediately after training, four times per week for 12 weeks.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Muscle Mass
Tidsramme: Baseline and Week 12
|
Muscle mass is assessed using Dual-energy X-ray Absorptiometry (DXA).
The change is evaluated by comparing the baseline values to the post-intervention values.
|
Baseline and Week 12
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB-2023-050
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Kropssammensætning
-
Kirsehir Ahi Evran UniversitesiRekrutteringBMI | Body Mass Index 25 eller højere | Body Mass Index, NormalKalkun
-
University Hospital, GenevaVBertoniMalufAktiv, ikke rekrutterendeLean Body MassSchweiz
-
CMH Lahore Medical College and Institute of DentistryLahore University of Management SciencesAfsluttetBody Mass Index, Normal | Body Mass Index 18,5 eller højerePakistan
-
University of Southern CaliforniaAfsluttetTotal Body Water AssessmentForenede Stater
-
Ankara Yildirim Beyazıt UniversityCyprus International UniversityAfsluttetFunktionel ydeevne | Kampsport | Body BuildingKalkun
-
Shanghai Zhongshan HospitalRekrutteringHigh Flow næsekanyle | Body Roundness IndexKina
-
Abcuro, Inc.Aktiv, ikke rekrutterendeInclusion Body Myositis (IBM)Forenede Stater, Australien
-
Oslo University HospitalThe Dam Foundation; The Norwegian Rheumatism AssociationAfsluttetForundersøgelse | Inclusion Body Myositis (IBM)Norge
-
Institut National de la Santé Et de la Recherche...AfsluttetInclusion Body Myositis (IBM)Frankrig
-
Ludwig-Maximilians - University of MunichAfsluttetInclusion Body Myositis, Sporadisk | Inclusion Body Myopati, Autosomal-recessiv | Inclusion Body Myopati, Autosomal-dominant | Medfødt grå stær, ansigtsdysmorfi og neuropatiTyskland
Kliniske forsøg med Whey Protein Concentrate
-
Maastricht University Medical CenterAfsluttetMuskelproteinsynteseHolland
-
University of ArkansasNational Dairy CouncilRekrutteringPrædiabetes / Type 2-diabetesForenede Stater
-
Société des Produits Nestlé (SPN)Afsluttet
-
University of ExeterRekrutteringSunde deltagereDet Forenede Kongerige
-
Wageningen University and ResearchAfsluttet
-
Wageningen University and ResearchAfsluttet
-
BIO-CAT, Inc.McGill UniversityAfsluttetAppetitiv adfærd | Gastrointestinal sundhed | FordøjelsessundhedCanada
-
GPLIFE HEALTHCARE PRIVATE LIMITEDAfsluttetMild kognitiv svækkelse | Aldersrelateret funktionsnedgangIndien
-
The University of Texas Medical Branch, GalvestonMeiji Co., Ltd.Afsluttet
-
Purdue UniversityAfsluttet