Athletic Performance EnhancementPLANT-ANIMAL-PNCT07571720
Effect of Plant vs Animal Protein Supplementation on Body Composition in Youth Soccer Players
A study testing Plant-Based Protein Supplement and Animal-Based Protein Supplement (Whey) in people with Athletic Performance Enhancement and Body Composition Optimization, run by Antonio Molina Lopez at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 19 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Athletic Performance Enhancement, Body Composition Optimization, Nutritional Supplementation in Athletes
- What is being tested?
- Plant-Based Protein Supplement and Animal-Based Protein Supplement (Whey)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 17 Jan 2026to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 19 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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).
Read the detailed description
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.
- Conditions
- Athletic Performance Enhancement, Body Composition Optimization, Nutritional Supplementation in Athletes
- Being tested
- Plant-Based Protein Supplement, Animal-Based Protein Supplement (Whey), Placebo
- Keywords
- Protein supplementation, Plant-based protein, Animal-based protein, Soy protein, Body composition, Lean mass, Fat-free mass, Soccer players, Youth athletes, Elite athletes, Sports nutrition, Post-exercise nutrition, Athletic performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant-Based Protein SupplementDietary supplement
Also called Soy protein, Plant protein blend, Vegetable protein
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.
Animal-Based Protein Supplement (Whey)Dietary supplement
Also called Whey protein, Dairy protein, Milk protein
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.
PlaceboDietary supplement
Also called Control, Placebo comparator
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0) and Final Assessment (Week 4)
Secondary outcomes (7)
Change in Body Fat Percentage
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.
Measured: Baseline (Week 0) and Final Assessment (Week 4)
Change in Total Body Mass
Change in total body weight (kg) from baseline to week 4.
Measured: Baseline (Week 0) and Final Assessment (Week 4)
Change in Total Lean Mass by DEXA
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.
Measured: Baseline (Week 0) and Final Assessment (Week 4)
Change in Sum of Skinfolds
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.
Measured: Baseline (Week 0) and Final Assessment (Week 4)
Change in Limb Circumferences
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.
Measured: Baseline (Week 0) and Final Assessment (Week 4)
Supplementation Adherence Rate
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.
Measured: Throughout 4-week intervention period
Adverse Events
Number and type of adverse events (gastrointestinal distress, allergic reactions, or any other adverse effects) related to supplement consumption.
Measured: Throughout 4-week intervention period and 1 week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start17 Jan 2026
- Primary completion18 Feb 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Athletic Performance EnhancementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm parallel group design with 1:1:1 randomization ratio
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antonio Molina Lopez
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Europea de Madrid, Universidad Pablo de Olavide
- Responsible party
- Sponsor-investigator, Antonio Molina Lopez, Universidad Pablo de Olavide
- Investigators
- Antonio Blas Molina Lopez, Phd, Principal investigator, CTS-595 Research Group, Centre for Research into Physical and Sporting Performance. Universidad Pablo de Olavide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571720
- Sponsor's protocol ID
- UC-PLANTANIMAL-PROT-2026
- Acronym
- PLANT-ANIMAL-P
- Status last verified
- May 2026
- First submitted
- 8 Mar 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07571720
- Acronym / sponsor ID
- PLANT-ANIMAL-P / UC-PLANTANIMAL-PROT-2026
- Conditions
- Athletic Performance Enhancement, Body Composition Optimization, Nutritional Supplementation in Athletes
- Keywords
- Protein supplementation, Plant-based protein, Animal-based protein, Soy protein, Body composition, Lean mass, Fat-free mass, Soccer players
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Antonio Molina LopezUniversity, hospital or other
- Collaborators
- Universidad Europea de Madrid, Universidad Pablo de Olavide
- Study start
- 17 Jan 2026 (actual)
- Primary completion
- 18 Feb 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm parallel group design with 1:1:1 randomization ratio
| Arm | Type | Receives |
|---|---|---|
| Plant Protein Group | Experimental | Dietary Supplement: Plant-Based Protein SupplementParticipants 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. |
| Animal Protein Group | Active comparator | Dietary Supplement: Animal-Based Protein Supplement (Whey)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. |
| Placebo Group | Placebo comparator | Dietary Supplement: PlaceboParticipants 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. |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plant-Based Protein SupplementAlso: Soy protein, Plant protein blend, Vegetable proteinComposition 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. | Dietary supplement | Plant Protein Group |
| Animal-Based Protein Supplement (Whey)Also: Whey protein, Dairy protein, Milk proteinComposition 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. | Dietary supplement | Animal Protein Group |
| PlaceboAlso: Control, Placebo comparatorComposition 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. | Dietary supplement | Placebo Group |
Primary outcome
Change in Fat-Free Mass (Lean Body Mass)
Time frame: 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.
7 secondary outcomes
Change in Body Fat Percentage
Time frame: Baseline (Week 0) and Final Assessment (Week 4)
Change in Total Body Mass
Time frame: Baseline (Week 0) and Final Assessment (Week 4)
Change in Total Lean Mass by DEXA
Time frame: Baseline (Week 0) and Final Assessment (Week 4)
Change in Sum of Skinfolds
Time frame: Baseline (Week 0) and Final Assessment (Week 4)
Change in Limb Circumferences
Time frame: Baseline (Week 0) and Final Assessment (Week 4)
Supplementation Adherence Rate
Time frame: Throughout 4-week intervention period
Adverse Events
Time frame: Throughout 4-week intervention period and 1 week post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Yes
Related trials for Athletic Performance Enhancement
Active, not recruiting
Effects of Blood Flow Restriction Training on Physical Function, Muscle Adaptations, and Performance in Roller Skaters
Athletic Performance Enhancement
Not yet recruiting
Effects of Blood Flow Restriction Training on Neuromuscular Function and Performance in Artistic Jump Rope Athletes
Neuromuscular Function, Athletic Performance Enhancement
Active, not recruiting
Effects of Microdosed Plyometric Training on Lower-Limb Neuromuscular Function and Sport-Specific Performance in Rope-Skipping Athletes
Athletic Performance Enhancement
Enrolling by invitation
Acute Effects of Bilateral Versus Unilateral Isometric Conditioning Activity on Jump Performance in Volleyball Players
Athletic Performance, Volleyball
Enrolling by invitation
NASM OPT for Pectoral Enhancement and Breast Firmness
Low Back Pain, Muscle Weakness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Blas Molina Lopez, Phd principal investigator
CTS-595 Research Group, Centre for Research into Physical and Sporting Performance. Universidad Pablo de Olavide
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant-Based Protein Supplement and Animal-Based Protein Supplement (Whey) in people with Athletic Performance Enhancement and Body Composition Optimization, run by Antonio Molina Lopez at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fat-Free Mass (Lean Body Mass) (time frame: Baseline (Week 0) and Final Assessment (Week 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.