- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07571720
Effect of Plant vs Animal Protein Supplementation on Body Composition in Youth Soccer Players (PLANT-ANIMAL-P)
A Prospective, Single-Blind, Randomized Controlled Trial Comparing Plant-Based and Animal-Based Protein Supplementation Effects on Body Composition and Lean Mass in Elite Male Youth Soccer Players: A 4-Week Intervention Study
Przegląd badań
Status
Warunki
Szczegółowy opis
BACKGROUND AND RATIONALE Protein supplementation is widely used in elite sports to support muscle protein synthesis and recovery. While animal-based proteins (particularly whey) have traditionally been considered superior due to their complete amino acid profile, plant-based proteins have gained attention for ethical, environmental, and health reasons. However, limited evidence exists comparing their efficacy in elite youth athletes during competitive periods with high training loads. This study addresses this gap by comparing isocaloric, iso-nitrogenous plant-based and animal-based protein supplements on body composition in elite male youth soccer players during a 4-week competitive phase.
STUDY DESIGN Prospective, single-blind, randomized controlled trial with three parallel arms (1:1:1 allocation). Participants are unaware of group assignment and cannot identify supplement content due to identical packaging and delivery methods.
POPULATION Male youth soccer players (ages 16-18.7 years) from Udinese Calcio's Primavera (U-19) category during the 2025-2026 season, maintaining regular training schedules (minimum 4 sessions/week) combining technical-tactical field training and strength conditioning.
INTERVENTION
Participants are randomized to three groups:
- Plant Protein Group (n=8): 330ml soy beverage + 22g plant protein powder = 17.4g total protein
- Animal Protein Group (n=9): 200ml rice beverage + 33g whey protein (22g neutral + 11g vanilla) = 17.3g total protein
- Placebo Group (n=8): 200ml rice beverage + vanilla flavoring = 0.2g total protein
Supplements are administered post-training (15-30 minutes) under direct nutrition staff supervision. Consumption is verified before participants leave the recovery area.
SUPPLEMENT PREPARATION Prepared 8 hours before consumption (09:00h) in individual labeled containers. Liquids measured with precision graduated containers, protein powder added via funnel (11g scoop). Containers manually shaken, refrigerated at 4°C, and re-shaken before consumption (17:00h).
BLINDING Single-blind design: participants unaware of three distinct groups; all containers and delivery identical. Nutrition staff aware of assignments (necessary for preparation and safety).
TRAINING CONTEXT Intervention occurs during competitive season with official matches every Saturday. Training microcycle features undulating workload with high-volume sessions (field + gym) on Tuesdays and Wednesdays. Following baseline assessment, players receive general nutritional guidelines but no strict dietary control (maintains ecological validity).
BODY COMPOSITION ASSESSMENT Multi-compartmental model maximizes precision. Participants maintain 8-hour fast and perform last urination 30 minutes before 07:00h assessment.
Assessment sequence:
- Bioelectrical Impedance Analysis (BIA 101 BIVA PRO): Verifies stable hydration via Bioelectrical Impedance Vector Analysis (BIVA)
Anthropometry (ISAK protocol): International Society for Advancement of Kinanthropometry standardized restricted profile. Same certified evaluator performs all measurements on right body side:
- 8 skinfolds: triceps, subscapular, biceps, iliac crest, supraspinal, abdominal, front thigh, medial calf
- 3 circumferences: relaxed arm, mid-thigh, calf
- Body fat via Faulkner formula: %FAT = [(triceps+subscapular+suprailiac+abdominal) × 0.153 + 5.783]
- Dual-Energy X-ray Absorptiometry (DEXA): Gold standard providing detailed fat mass, lean mass, bone mineral density, and regional distribution analysis
Assessment timeline: Baseline (Week 0) and Final (Week 4) with identical protocols.
STATISTICAL ANALYSIS Primary analysis: One-way ANOVA (or Kruskal-Wallis if non-normal) comparing mean fat-free mass changes between groups. Post-hoc tests (Bonferroni/Tukey HSD) for pairwise comparisons if significant. Secondary analyses use similar approaches. Intention-to-treat includes all randomized participants; per-protocol includes participants with ≥80% adherence. Baseline values, training load, and dietary intake may be covariates in ANCOVA models. Significance: α=0.05 (two-tailed).
SAMPLE SIZE N=25 (8-9 per group) based on feasibility given specialized population. This pilot study may detect moderate-large effects (Cohen's d≥0.6-0.8) using sensitive multi-compartmental methods.
SAFETY MONITORING Participants instructed to report adverse effects immediately. Regular check-ins during training, standardized adverse event documentation, classification by severity and relationship to intervention. Medical staff available during all sessions.
STUDY OBJECTIVES Primary: Compare effects of plant-based vs animal-based vs placebo protein supplementation on lean body mass changes in elite male youth soccer players over 4 weeks during competitive season.
Secondary: Compare effects on body fat percentage, total body mass, regional body composition, individual skinfold measurements, circumferences, adherence rates, and adverse events.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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-
Udine
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Udine, Udine, Włochy, 33100
- Udinese Calcio
-
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Active contract with Udinese Calcio's Primavera (U-19) category during the 2025-2026 season
- Regular participation in the team's technical-tactical and strength training program (minimum 4 sessions per week)
- Signed informed consent (parental consent for participants under 18 years)
- Commitment to adhere to measurement protocol requiring 8-hour fast and assessment at 07:00h
- Commitment to adhere to post-training supplementation protocol with administration at 17:00h
- Confirmed presence and availability for both baseline assessment (Week 0) and final assessment (Week 4)
Exclusion Criteria:
- Open injury records or currently in functional readaptation phase at study initiation
- Consumption of ergogenic or nutritional supplementation independently and external to the club-supervised protocol during the 4 weeks prior to study or during the study period
- Previous diagnosis or current symptomatology compatible with eating disorders
- Known allergies or intolerances to soy, rice, dairy-based proteins, or vanilla flavoring
- Current use of medications that may affect body composition or protein metabolism (anabolic steroids, growth hormone, corticosteroids, thyroid hormones)
- Diagnosed chronic diseases that may affect protein metabolism or body composition (diabetes mellitus, chronic kidney disease, liver disease, malabsorption syndromes)
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Plant Protein Group
Participants receive plant-based protein supplementation (17.4g protein per dose) consisting of 330ml soy beverage and 22g plant-based protein powder, administered within 15-30 minutes post-training under direct supervision for 4 weeks during competitive season.
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Composition per dose: 330ml soy beverage (10.8g protein) + 22g plant protein powder (6.6g protein) = 17.4g total protein.
Administered post-training (15-30 min after), prepared 8 hours before, stored at 4°C, supervised consumption verified by nutrition staff.
Inne nazwy:
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Aktywny komparator: Animal Protein Group
Participants receive animal-based protein supplementation (17.3g protein per dose) consisting of 200ml rice beverage and 33g whey protein powder blend, administered within 15-30 minutes post-training under direct supervision for 4 weeks during competitive season.
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Composition per dose: 200ml rice beverage (0.2g protein) + 22g neutral whey protein (12.0g protein) + 11g vanilla whey protein (5.1g protein) = 17.3g total protein.
Administered post-training (15-30 min after), prepared 8 hours before, stored at 4°C, supervised consumption verified by nutrition staff.
Inne nazwy:
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Komparator placebo: Placebo Group
Participants receive placebo supplementation (0.2g protein per dose) consisting of 200ml rice beverage and vanilla flavoring, administered within 15-30 minutes post-training under direct supervision for 4 weeks during competitive season.
Appearance and delivery identical to active interventions.
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Composition per dose: 200ml rice beverage (0.2g protein) + vanilla flavoring = 0.2g total protein.
Administered post-training (15-30 min after), prepared 8 hours before, stored at 4°C, supervised consumption verified by nutrition staff.
Identical appearance to active supplements to maintain blinding.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Fat-Free Mass (Lean Body Mass)
Ramy czasowe: Baseline (Week 0) and Final Assessment (Week 4)
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Change in fat-free mass (kg) from baseline to week 4, assessed using a multi-compartmental model combining bioelectrical impedance analysis (BIA), anthropometry according to ISAK protocol, and dual-energy X-ray absorptiometry (DEXA).
Fat-free mass represents total body mass minus fat mass.
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Baseline (Week 0) and Final Assessment (Week 4)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Body Fat Percentage
Ramy czasowe: Baseline (Week 0) and Final Assessment (Week 4)
|
Change in body fat percentage from baseline to week 4, calculated using the Faulkner formula from skinfold measurements and validated by DEXA assessment.
The Faulkner formula is: % FAT = (TR+SE+SI+AB) × 0.153 + 5.783, where TR=triceps, SE=subscapular, SI=suprailiac, AB=abdominal skinfolds in millimeters.
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Baseline (Week 0) and Final Assessment (Week 4)
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Change in Total Body Mass
Ramy czasowe: Baseline (Week 0) and Final Assessment (Week 4)
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Change in total body weight (kg) from baseline to week 4.
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Baseline (Week 0) and Final Assessment (Week 4)
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Change in Total Lean Mass by DEXA
Ramy czasowe: Baseline (Week 0) and Final Assessment (Week 4)
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Change in whole-body lean mass (kg) from baseline to week 4, assessed by dual-energy X-ray absorptiometry (DEXA) as a single composite measurement of total lean tissue.
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Baseline (Week 0) and Final Assessment (Week 4)
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Change in Sum of Skinfolds
Ramy czasowe: Baseline (Week 0) and Final Assessment (Week 4)
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Change in sum of 8 skinfolds from baseline to week 4, measured according to ISAK protocol.
The 8 individual skinfold measurements (triceps, subscapular, biceps, iliac crest, supraspinal, abdominal, front thigh, and medial calf in millimeters) will be summed to create a single aggregate value representing total subcutaneous adiposity.
Results will be reported as mean change in total sum of skinfolds ± standard deviation.
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Baseline (Week 0) and Final Assessment (Week 4)
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Change in Limb Circumferences
Ramy czasowe: Baseline (Week 0) and Final Assessment (Week 4)
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Changes in circumference measurements from baseline to week 4, measured according to ISAK protocol.
The 3 circumference measurements (relaxed arm, mid-thigh, and medial calf in centimeters) will be analyzed separately and reported as individual values for each site.
Results will show mean change ± standard deviation for each circumference measurement independently.
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Baseline (Week 0) and Final Assessment (Week 4)
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Supplementation Adherence Rate
Ramy czasowe: Throughout 4-week intervention period
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Percentage of prescribed supplement doses consumed throughout the 4-week intervention period, calculated as (number of doses consumed / number of doses prescribed) × 100.
Adherence is verified by direct observation and documentation by nutrition staff at each administration.
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Throughout 4-week intervention period
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Adverse Events
Ramy czasowe: Throughout 4-week intervention period and 1 week post-intervention
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Number and type of adverse events (gastrointestinal distress, allergic reactions, or any other adverse effects) related to supplement consumption.
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Throughout 4-week intervention period and 1 week post-intervention
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Antonio Blas Molina Lopez, Phd, CTS-595 Research Group, Centre for Research into Physical and Sporting Performance. Universidad Pablo de Olavide
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Aminokwasy, peptydy i białka
- Białka
- Żywność
- Dieta, żywność i odżywianie
- Zjawiska fizjologiczne
- Jedzenie i napoje
- Napoje
- Produkty mleczne
- Mleko
- Białka dietetyczne
- Białka roślinne
- Białka zwierzęce, dieta
- Żywność sojowa
- Produkty Warzywne
- Warzywa
- Serwatka
- Białka serwatki
- Białka Sojowe
- Plant Proteins, Dietary
- Milk Proteins
Inne numery identyfikacyjne badania
- UC-PLANTANIMAL-PROT-2026
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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