NCT07571720

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2026

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2026

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

1 month

First QC Date

March 8, 2026

Last Update Submit

May 2, 2026

Conditions

Athletic Performance EnhancementBody Composition OptimizationNutritional Supplementation in Athletes

Keywords

Protein supplementationPlant-based proteinAnimal-based proteinSoy proteinBody compositionLean massFat-free massSoccer playersYouth athletesElite athletesSports nutritionPost-exercise nutritionAthletic performance

Outcome Measures

Primary Outcomes (1)

  • Change in Fat-Free Mass (Lean Body Mass)

    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.

    Baseline (Week 0) and Final Assessment (Week 4)

Secondary Outcomes (7)

  • 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)

  • +2 more secondary outcomes

Study Arms (3)

Plant Protein Group

EXPERIMENTAL

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.

Dietary Supplement: Plant-Based Protein Supplement

Animal Protein Group

ACTIVE COMPARATOR

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.

Dietary Supplement: Animal-Based Protein Supplement (Whey)

Placebo Group

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

Animal-Based Protein Supplement (Whey)DIETARY_SUPPLEMENT

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.

Also known as: Whey protein, Dairy protein, Milk protein
Animal Protein Group
PlaceboDIETARY_SUPPLEMENT

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.

Also known as: Control, Placebo comparator
Placebo Group
Plant-Based Protein SupplementDIETARY_SUPPLEMENT

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.

Also known as: Soy protein, Plant protein blend, Vegetable protein
Plant Protein Group

Eligibility Criteria

Age16 Years - 19 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Udinese Calcio

Udine, Udine, 33100, Italy

Location

MeSH Terms

Interventions

Soybean ProteinsPlant Proteins, DietaryWheyWhey ProteinsMilk Proteins

Intervention Hierarchy (Ancestors)

Plant ProteinsProteinsAmino Acids, Peptides, and ProteinsDietary ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaSoy FoodsVegetable ProductsVegetablesFood and BeveragesMilkBeveragesDairy ProductsAnimal Proteins, Dietary

Study Officials

  • Antonio Blas Molina Lopez, Phd

    CTS-595 Research Group, Centre for Research into Physical and Sporting Performance. Universidad Pablo de Olavide

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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).
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Three-arm parallel group design with 1:1:1 randomization ratio
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Investigator, PhD, CTS-595 Research Group, Centre for Research into Physical and Sporting Performance Affiliation: Universidad Pablo de Olavide

Study Record Dates

First Submitted

March 8, 2026

First Posted

May 6, 2026

Study Start

January 17, 2026

Primary Completion

February 18, 2026

Study Completion

March 30, 2026

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Individual participant data will be available immediately following publication of the primary manuscript and will remain available for at least 5 years. Supporting documents (study protocol and statistical analysis plan) will be available indefinitely.
Access Criteria
De-identified individual participant data will be shared with researchers who provide a methodologically sound proposal for academic purposes. Requests should be directed to the corresponding author at antoniomolina@centrosnutrifarma.es. Requestors will need to sign a data access agreement and specify the intended use of the data. Data will be provided in anonymized CSV format via secure file transfer within 30 days of approval.

Locations

IT(1)