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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in Fat-Free Mass (Lean Body Mass)
研究概览
简要总结
This prospective, single-blind, randomized controlled trial investigates the comparative effects of plant-based protein (soy and rice blend) versus animal-based protein (whey) supplementation on body composition parameters in elite male youth soccer players. Twenty-five players (ages 16-18.7 years) from Udinese Calcio's Primavera (U-19) category are randomized into three groups: Plant Protein Group (n=8), Animal Protein Group (n=9), and Placebo Group (n=8). The intervention consists of post-training protein supplementation (17g protein/dose) administered within 15-30 minutes after each training session over a 4-week microcycle during the competitive season. Body composition is assessed using a multi-compartmental model including anthropometry (ISAK protocol), bioelectrical impedance analysis (BIA), and dual-energy X-ray absorptiometry (DEXA).
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants are blinded to group assignment and the existence of three distinct intervention groups. All supplements are prepared and delivered in identical containers. Nutrition staff administering supplements are not blinded (necessary for proper preparation).
入排标准
- 年龄范围
- 16 Years 至 19 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Plant-Based Protein Supplement (Dietary Supplement)
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.
干预措施: Animal-Based Protein Supplement (Whey) (Dietary Supplement)
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.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in Fat-Free Mass (Lean Body Mass)
时间窗: Baseline (Week 0) and Final Assessment (Week 4)
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.
次要结局
- Change in Body Fat Percentage(Baseline (Week 0) and Final Assessment (Week 4))
- Change in Total Body Mass(Baseline (Week 0) and Final Assessment (Week 4))
- Change in Total Lean Mass by DEXA(Baseline (Week 0) and Final Assessment (Week 4))
- Change in Sum of Skinfolds(Baseline (Week 0) and Final Assessment (Week 4))
- Change in Limb Circumferences(Baseline (Week 0) and Final Assessment (Week 4))
- Supplementation Adherence Rate(Throughout 4-week intervention period)
- Adverse Events(Throughout 4-week intervention period and 1 week post-intervention)
研究者
Antonio Molina Lopez
Investigator, PhD, CTS-595 Research Group, Centre for Research into Physical and Sporting Performance Affiliation: Universidad Pablo de Olavide
Universidad Pablo de Olavide