Skeletal Muscle DamageNCT03753321
Whey and Soy Protein Supplementation in Football Players
A study testing Whey protein and Soy protein in people with Skeletal Muscle Damage and Muscle Damage, run by University of Thessaly at 1 site in Greece.
Trial summary
In a constant effort to find ways to make a quicker recovery between demanding workouts and football matches, this study is the first to investigate the benefits of protein supplementation, and compares two types of proteins, an animal-derived (whey) and a plant-derived (soy) protein, after an exercise-induced muscle… Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Skeletal Muscle Damage, Muscle Damage, Athletic Performance
- What is being tested?
- Whey protein and Soy protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteGreece
- Study dates
- 8 Nov 2018to 20 Feb 2019
- 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 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Playing at a competitive level (top three divisions) for ≥3 years
- Free of any recent history of illnesses, musculoskeletal problems and metabolic diseases
- No use of supplements and medications (for ≤6 months prior to the study)
- Non-smokers
Who cannot join
- A known milk intolerance or allergy
- A recent febrile illness
- History of muscle lesion
- Lower limb trauma
- Metabolic diseases.
Trial locations and contacts
1 site in 1 country.
Greece1 site
Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly
Trikala, 42100
About this study
Official title: Comparison of the Effect of Whey and Soy Protein Supplementation on Muscle Damage Markers and Performance After a Speed Endurance Training Protocol in Football Players
In a constant effort to find ways to make a quicker recovery between demanding workouts and football matches, this study is the first to investigate the benefits of protein supplementation, and compares two types of proteins, an animal-derived (whey) and a plant-derived (soy) protein, after an exercise-induced muscle injury caused by a speed endurance training protocol. Soy protein could be a cheaper and more environment-friendly alternative for athletes involved in high-velocity strength training.
Read the detailed description
A randomized, three-trial (placebo vs. whey protein isolate vs. soy protein isolate consumption), cross-over, double-blind design.
- Baseline performance testing: Initially, volunteers will participate in a performance testing procedure at University facilities. These measurements include:
- measurement of descriptor variables: a) body composition (DXA), b) VO2max, c) Yo-Yo intermittent endurance level 2 (Yo-Yo IE2), d) Yo-Yo intermittent recovery test level 2 (Yo-Yo IR2), e) technical skill level, f) daily dietary intake profile (over a 7-day period), g) gabitual physical activity level (over a 7-day period) and h) resting mtabolic rate (RMR).
- Measurement of dependent variables: a) isokinetic strength (concentric, eccentric) and maximal voluntary isometric contraction (MVIC) of knee extensors and flexors of both lower limbs, b) counter movement jump height (CMJ), c) repeated sprint ability (RSA), d) speed (10 and 30 m), e) delayed onset of muscle soreness (DOMS), f) blood sampling for measurement of lactate concentration, creatine kinase activity (CK) and inflammatory markers [i.e.Glutathione (GSH), total antioxidant capacity (TAC) and protein carbonyls (PC)].
- A 1-week adaptive period: based on a dietary analysis, participants will be given a dietary plan [taking into account the resting metabolic rate (RMR) and total daily physical activity related energy expenditure], providing a standard protein intake of 0.8-1 g protein/kg/day over the 1-week adaptive period. This protein intake is accepted as the average and population-safe protein intake during periods of very low physical activity and/or exercise levels. RMR, daily dietary intake and physical activity will be measured before the adaptive period. Familiarization with the training protocol will take place during this phase.
- Participants will randomly participate in three trials including: whey protein (WP), soy protein (SP) and placebo (PL) supplementation:
- A 7-day pre-loading phase: A 7-day pre-loading phase will be applied prior to each trial, during which volunteers will receive the respective supplement (placebo, whey protein or soy protein). In WP and SP trials, participants will consume daily the appropriate amount of protein to reach a total protein intake of 1.5 g protein/kg body weight (BW).
- On the 7th day (end of pre-loading phase), participants will repeat performance testing (assessment of all dependent variables according to baseline testing) and blood sampling.
- On the 8th day, participants will perform the speed-endurance production training (SEPT) session 1 (1st trial). During training, participants internal (heart rate) and external load (total distance, speed zones, acceleration and decelerations, impacts) will be continuously monitored using heart rate monitors and global positioning system (GPS) instrumentation.
- Immediately after the training protocol: Determination of blood lactate concentration (3-4 minutes post-training) and assessment of MVIC (1 hour, 2 hours and 3 hours post-training).
- 1-Day post-training (9th day; 24 hours post-training): Blood sampling (for the determination of CK, GSH, TAC and PC) and measurement of dependent variables (i.e. isokinetic strength, MVIC, Speed, RSA, CMJ and DOMS).
- 2-Days post-training (10th day; 48 hours post-training): Blood sampling (for the determination of CK, GSH, TAC and PC) and assessment of DOMS. Thereafter, the SEPT session 2 will take place during which the particpants' internal and external load will be continuously monitored (as described in SEPT session 1).
- Wash-out period: 2-week without any activity or supplementation.
- 2nd trial: repeat of stages 3 and 4.
- 3rd trial: repeat of stage 3.
- Conditions
- Skeletal Muscle Damage, Muscle Damage, Athletic Performance
- Being tested
- Whey protein, Soy protein, Placebo (maltodextrin)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey proteinDietary supplement
Whey protein isolate supplementation, individually adjusted to reach a total protein intake of 1.5 g/kg body weight/day for 10 days (7 days pre-loading and 3 days during trials 1 and 2)
Soy proteinDietary supplement
Soy protein isolate supplementation, individually adjusted to reach a total protein intake of 1.5 g/kg body weight/day for 10 days (7 days pre-loading and 3 days during trials 1 and 2)
Placebo (maltodextrin)Dietary supplement
Isoenergetic placebo (maltodextrin) for 10 days (7 days pre-loading and 3 days during trials 1 and 2
| Study group | Role | What they receive |
|---|---|---|
| Whey protein | Experimental | Whey protein isolate supplementation (7 day pre-loading phase and 3 day training phase). The protein dose will be individually adjusted to reach a total protein intake of 1.5 g protein/kg body mass/day. Receives: Dietary Supplement: Whey protein |
| Soy protein | Experimental | Soy protein isolate supplementation (7 day pre-loading phase and 3 day training phase). The protein dose will be individually adjusted to reach a total protein intake of 1.5 g protein/kg body mass/day. Receives: Dietary Supplement: Soy protein |
| Placebo (maltodextrin) | Placebo comparator | Isoenergetic, maltodextrin (7 day pre-loading phase and 3 day training phase) Receives: Dietary Supplement: Placebo (maltodextrin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in field activity during the speed-endurance production training (SEPT)
Field activity will be continuously recorded during both SEPT sessions using global positioning system (GPS) technology
Measured: Throughout the SEPT sessions in all trials
Change in heart rate during the speed-endurance production training (SEPT)
Heart rate will be continuously recorded during both SEPT sessions using heart rate monitors.
Measured: Throughout the SEPT sessions in all trials
Change in creatine kinase in plasma
Concentration of creatine kinase will be measured in plasma
Measured: Baseline; Post-loading (Day 7); 24 hours (Day 9) and 48 hours (Day 10) following SEPT session 1.
Change in repeated sprint ability (RSA)
5 x 30 m sprints will be performed with 25 seconds rest in-between
Measured: Baseline; Post-loading (Day 7); 24 hours (Day 9) following SEPT session 1
Change in countermovement jump (jump height in centimeters)
Countermovement jump will be assessed on a contact platform
Measured: Baseline; Post-loading (Day 7); 24 hours (Day 9) following SEPT session 1
Change in isokinetic strength of lower limbs
Isokinetic strength will be assessed on an isokinetic dynamometer for both knee extensors and knee flexors at 60 degrees.
Measured: Baseline; Post-loading (Day 7); 24 hours (Day 9) following SEPT session 1
Change in maximal voluntary isometric contraction (MVIC) of lower limbs
MVIC will be assessed on an isokinetic dynamometer for knee extensors at 90 degrees and knee flexors at 30 degrees
Measured: Baseline; Post-loading (Day 7); 1, 2 and 3 hours post-SEPT session 1; 24 hours (Day 9) and 48 hours (Day 10) following SEPT session 1.
Change in delayed onset of muscle soreness
Muscle soreness will assessed during palpation of the muscle belly and the distal region of relaxed vastus medialis, vastus lateralis and rectus femoris following three repetitions of of a full squat. Subjects will rate their DOMS on a visual analogue scale (0-10). A score of O indicates no sign or symptom of DOMS, a score of 10 indicated severe signs and symptoms of delayed onset muscle soreness (DOMS). These signs and symptoms include dull, diffuse pain and tenderness; stiffness; swelling; and decreased strength of the exercised muscle.
Measured: Baseline; Post-loading (Day 7); 24 hours (Day 9) and 48 hours (Day 10) following SEPT session 1.
Change in total antioxidant capacity in plasma
Total antioxidant capacity will be measured in plasma
Measured: Baseline; Post-loading (Day 7); 24 hours (Day 9) and 48 hours (Day 10) following SEPT session 1.
Change in protein carbonyl levels in plasma
Protein carbonyl levels will be measured in plasma
Measured: Baseline; Post-loading (Day 7); 24 hours (Day 9) and 48 hours (Day 10) following SEPT session 1.
Change in GSH levels in red blood cell lysate
GSH will be measured in red blood cell lysate
Measured: Baseline; Post-loading (Day 7); 24 hours (Day 9) and 48 hours (Day 10) following SEPT session 1.
Change in sprint time
Sprint time will be assessed over a 10m and 30m distance using light cells.
Measured: Baseline; Post-loading (Day 7); 24 hours (Day 9) following SEPT session 1
Secondary outcomes (7)
Dietary intake
Dietary intake will be assessed using 7-day diet recalls.
Measured: Over a 7-day period at baseline.
Concentration of blood lactate
Blood lactate will be measured using an automatic analyzer
Measured: Pre- and Post-SEPT session 1 (Day 8), Pre- and Post-SEPT session 2 (Day 10)
Change in habitual physical activity
Physical activity will be measured using 3-axial accelerometers
Measured: Over a 7-day period at baseline
Change in resting metabolic rate (RMR)
RMR will be measured using open-circuit indirect calorimeter with a ventilated hood system, after an overnight fast.
Measured: At baseline.
Change in body composition
Body composition will be assessed using dual-energy X-ray absorptiometry (DXA).
Measured: At baseline.
Change in maximal oxygen uptake
Maximal oxygen uptake (VO2max) will be measured during a graded exercise testing on a treadmill, by using open-circuit spirometry with an automated online pulmonary gas exchange system, via breath-by-breath analysis.
Measured: At baseline.
Change in soccer-specific conditioning.
Soccer-specific conditioning will be assessed using the the Yo-Yo intermittent endurance level 2 test (Yo-Yo IE2) and the Yo-Yo intermittent recovery level 2 test (Yo-Yo IR2).
Measured: At baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start8 Nov 2018
- Primary completion20 Jan 2019
- Study completion20 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skeletal Muscle DamageStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ioannis G. Fatouros, University of Thessaly
- Investigators
- Savvas Kritikos, MScc, Principal investigator, UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753321
- Sponsor's protocol ID
- WHEY vs SOY PROTEIN - UTH
- Status last verified
- Nov 2020
- First submitted
- 12 Oct 2018
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kritikos S, Papanikolaou K, Draganidis D, Poulios A, Georgakouli K, Tsimeas P, Tzatzakis T, Batsilas D, Batrakoulis A, Deli CK, Chatzinikolaou A, Mohr M, Jamurtas AZ, Fatouros IG. Effect of whey vs. soy protein supplementation on recovery kinetics following speed endurance training in competitive male soccer players: a randomized controlled trial. J Int Soc Sports Nutr. 2021 Mar 16;18(1):23. doi: 10.1186/s12970-021-00420-w.
PubMed 33726784
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Whey and Soy Protein Supplementation on Muscle Damage Markers and Performance After a Speed Endurance Training Protocol in Football Players
- ClinicalTrials.gov ID
- NCT03753321
- Acronym / sponsor ID
- WHEY vs SOY PROTEIN - UTH
- Conditions
- Skeletal Muscle Damage, Muscle Damage, Athletic Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 20 Jan 2019 (actual)
- Study completion
- 20 Feb 2019 (actual)
- First posted
- 26 Nov 2018 (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.
In a constant effort to find ways to make a quicker recovery between demanding workouts and football matches, this study is the first to investigate the benefits of protein supplementation, and compares two types of proteins, an animal-derived (whey) and a plant-derived (soy) protein, after an exercise-induced muscle injury caused by a speed endurance training protocol. Soy protein could be a cheaper and more environment-friendly alternative for athletes involved in high-velocity strength training.
Detailed description
A randomized, three-trial (placebo vs. whey protein isolate vs. soy protein isolate consumption), cross-over, double-blind design.
- Baseline performance testing: Initially, volunteers will participate in a performance testing procedure at University facilities. These measurements include:
- measurement of descriptor variables: a) body composition (DXA), b) VO2max, c) Yo-Yo intermittent endurance level 2 (Yo-Yo IE2), d) Yo-Yo intermittent recovery test level 2 (Yo-Yo IR2), e) technical skill level, f) daily dietary intake profile (over a 7-day period), g) gabitual physical activity level (over a 7-day period) and h) resting mtabolic rate (RMR).
- Measurement of dependent variables: a) isokinetic strength (concentric, eccentric) and maximal voluntary isometric contraction (MVIC) of knee extensors and flexors of both lower limbs, b) counter movement jump height (CMJ), c) repeated sprint ability (RSA), d) speed (10 and 30 m), e) delayed onset of muscle soreness (DOMS), f) blood sampling for measurement of lactate concentration, creatine kinase activity (CK) and inflammatory markers [i.e.Glutathione (GSH), total antioxidant capacity (TAC) and protein carbonyls (PC)].
- A 1-week adaptive period: based on a dietary analysis, participants will be given a dietary plan [taking into account the resting metabolic rate (RMR) and total daily physical activity related energy expenditure], providing a standard protein intake of 0.8-1 g protein/kg/day over the 1-week adaptive period. This protein intake is accepted as the average and population-safe protein intake during periods of very low physical activity and/or exercise levels. RMR, daily dietary intake and physical activity will be measured before the adaptive period. Familiarization with the training protocol will take place during this phase.
- Participants will randomly participate in three trials including: whey protein (WP), soy protein (SP) and placebo (PL) supplementation:
- A 7-day pre-loading phase: A 7-day pre-loading phase will be applied prior to each trial, during which volunteers will receive the respective supplement (placebo, whey protein or soy protein). In WP and SP trials, participants will consume daily the appropriate amount of protein to reach a total protein intake of 1.5 g protein/kg body weight (BW).
- On the 7th day (end of pre-loading phase), participants will repeat performance testing (assessment of all dependent variables according to baseline testing) and blood sampling.
- On the 8th day, participants will perform the speed-endurance production training (SEPT) session 1 (1st trial). During training, participants internal (heart rate) and external load (total distance, speed zones, acceleration and decelerations, impacts) will be continuously monitored using heart rate monitors and global positioning system (GPS) instrumentation.
- Immediately after the training protocol: Determination of blood lactate concentration (3-4 minutes post-training) and assessment of MVIC (1 hour, 2 hours and 3 hours post-training).
- 1-Day post-training (9th day; 24 hours post-training): Blood sampling (for the determination of CK, GSH, TAC and PC) and measurement of dependent variables (i.e. isokinetic strength, MVIC, Speed, RSA, CMJ and DOMS).
- 2-Days post-training (10th day; 48 hours post-training): Blood sampling (for the determination of CK, GSH, TAC and PC) and assessment of DOMS. Thereafter, the SEPT session 2 will take place during which the particpants' internal and external load will be continuously monitored (as described in SEPT session 1).
- Wash-out period: 2-week without any activity or supplementation.
- 2nd trial: repeat of stages 3 and 4.
- 3rd trial: repeat of stage 3.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whey protein | Experimental | Dietary Supplement: Whey proteinWhey protein isolate supplementation (7 day pre-loading phase and 3 day training phase). The protein dose will be individually adjusted to reach a total protein intake of 1.5 g protein/kg body mass/day. |
| Soy protein | Experimental | Dietary Supplement: Soy proteinSoy protein isolate supplementation (7 day pre-loading phase and 3 day training phase). The protein dose will be individually adjusted to reach a total protein intake of 1.5 g protein/kg body mass/day. |
| Placebo (maltodextrin) | Placebo comparator | Dietary Supplement: Placebo (maltodextrin)Isoenergetic, maltodextrin (7 day pre-loading phase and 3 day training phase) |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Playing at a competitive level (top three divisions) for ≥3 years
- Free of any recent history of illnesses, musculoskeletal problems and metabolic diseases
- No use of supplements and medications (for ≤6 months prior to the study)
- Non-smokers
Key exclusion criteria (5 listed)
- A known milk intolerance or allergy
- A recent febrile illness
- History of muscle lesion
- Lower limb trauma
- Metabolic diseases.
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 |
|---|---|---|
| Whey proteinWhey protein isolate supplementation, individually adjusted to reach a total protein intake of 1.5 g/kg body weight/day for 10 days (7 days pre-loading and 3 days during trials 1 and 2) | Dietary supplement | Whey protein |
| Soy proteinSoy protein isolate supplementation, individually adjusted to reach a total protein intake of 1.5 g/kg body weight/day for 10 days (7 days pre-loading and 3 days during trials 1 and 2) | Dietary supplement | Soy protein |
| Placebo (maltodextrin)Isoenergetic placebo (maltodextrin) for 10 days (7 days pre-loading and 3 days during trials 1 and 2 | Dietary supplement | Placebo (maltodextrin) |
Primary outcome
Change in field activity during the speed-endurance production training (SEPT)
Time frame: Throughout the SEPT sessions in all trials
Field activity will be continuously recorded during both SEPT sessions using global positioning system (GPS) technology
Change in heart rate during the speed-endurance production training (SEPT)
Time frame: Throughout the SEPT sessions in all trials
Heart rate will be continuously recorded during both SEPT sessions using heart rate monitors.
Change in creatine kinase in plasma
Time frame: Baseline; Post-loading (Day 7); 24 hours (Day 9) and 48 hours (Day 10) following SEPT session 1.
Concentration of creatine kinase will be measured in plasma
Change in repeated sprint ability (RSA)
Time frame: Baseline; Post-loading (Day 7); 24 hours (Day 9) following SEPT session 1
5 x 30 m sprints will be performed with 25 seconds rest in-between
Change in countermovement jump (jump height in centimeters)
Time frame: Baseline; Post-loading (Day 7); 24 hours (Day 9) following SEPT session 1
Countermovement jump will be assessed on a contact platform
Change in isokinetic strength of lower limbs
Time frame: Baseline; Post-loading (Day 7); 24 hours (Day 9) following SEPT session 1
Isokinetic strength will be assessed on an isokinetic dynamometer for both knee extensors and knee flexors at 60 degrees.
Change in maximal voluntary isometric contraction (MVIC) of lower limbs
Time frame: Baseline; Post-loading (Day 7); 1, 2 and 3 hours post-SEPT session 1; 24 hours (Day 9) and 48 hours (Day 10) following SEPT session 1.
MVIC will be assessed on an isokinetic dynamometer for knee extensors at 90 degrees and knee flexors at 30 degrees
Change in delayed onset of muscle soreness
Time frame: Baseline; Post-loading (Day 7); 24 hours (Day 9) and 48 hours (Day 10) following SEPT session 1.
Muscle soreness will assessed during palpation of the muscle belly and the distal region of relaxed vastus medialis, vastus lateralis and rectus femoris following three repetitions of of a full squat. Subjects will rate their DOMS on a visual analogue scale (0-10). A score of O indicates no sign or symptom of DOMS, a score of 10 indicated severe signs and symptoms of delayed onset muscle soreness (DOMS). These signs and symptoms include dull, diffuse pain and tenderness; stiffness; swelling; and decreased strength of the exercised muscle.
Change in total antioxidant capacity in plasma
Time frame: Baseline; Post-loading (Day 7); 24 hours (Day 9) and 48 hours (Day 10) following SEPT session 1.
Total antioxidant capacity will be measured in plasma
Change in protein carbonyl levels in plasma
Time frame: Baseline; Post-loading (Day 7); 24 hours (Day 9) and 48 hours (Day 10) following SEPT session 1.
Protein carbonyl levels will be measured in plasma
Change in GSH levels in red blood cell lysate
Time frame: Baseline; Post-loading (Day 7); 24 hours (Day 9) and 48 hours (Day 10) following SEPT session 1.
GSH will be measured in red blood cell lysate
Change in sprint time
Time frame: Baseline; Post-loading (Day 7); 24 hours (Day 9) following SEPT session 1
Sprint time will be assessed over a 10m and 30m distance using light cells.
7 secondary outcomes
Dietary intake
Time frame: Over a 7-day period at baseline.
Concentration of blood lactate
Time frame: Pre- and Post-SEPT session 1 (Day 8), Pre- and Post-SEPT session 2 (Day 10)
Change in habitual physical activity
Time frame: Over a 7-day period at baseline
Change in resting metabolic rate (RMR)
Time frame: At baseline.
Change in body composition
Time frame: At baseline.
Change in maximal oxygen uptake
Time frame: At baseline.
Change in soccer-specific conditioning.
Time frame: At baseline.
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 24 Nov 2020.
- Derived from this study: PubMed 33726784Kritikos S, Papanikolaou K, Draganidis D, Poulios A, Georgakouli K, Tsimeas P, Tzatzakis T, Batsilas D, Batrakoulis A, Deli CK, Chatzinikolaou A, Mohr M, Jamurtas AZ, Fatouros IG. Effect of whey vs. soy protein supplementation on recovery kinetics following speed endurance training in competitive male soccer players: a randomized controlled trial. J Int Soc Sports Nutr. 2021 Mar 16;18(1):23. doi: 10.1186/s12970-021-00420-w.
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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.
Savvas Kritikos, MScc principal investigator
UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein and Soy protein in people with Skeletal Muscle Damage and Muscle Damage, run by University of Thessaly at 1 site in Greece.
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 4 inclusion and 5 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 24 Nov 2020. 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 Greece. 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 field activity during the speed-endurance production training (SEPT) (time frame: Throughout the SEPT sessions in all trials). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03753321, which also lists 1 linked publication.
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 24 Nov 2020.