NCT03753321

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

November 8, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 26, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2019

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

October 12, 2018

Last Update Submit

November 23, 2020

Conditions

Outcome Measures

Primary Outcomes (12)

  • 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

    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.

    Throughout the SEPT sessions in all trials

  • Change in creatine kinase in plasma

    Concentration of creatine kinase will be measured in plasma

    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

    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

    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.

    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

    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.

    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

    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

    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

    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.

    Baseline; Post-loading (Day 7); 24 hours (Day 9) following SEPT session 1

Secondary Outcomes (7)

  • Dietary intake

    Over a 7-day period at baseline.

  • Concentration of blood lactate

    Pre- and Post-SEPT session 1 (Day 8), Pre- and Post-SEPT session 2 (Day 10)

  • Change in habitual physical activity

    Over a 7-day period at baseline

  • Change in resting metabolic rate (RMR)

    At baseline.

  • Change in body composition

    At baseline.

  • +2 more secondary outcomes

Study Arms (3)

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.

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.

Dietary Supplement: Soy protein

Placebo (maltodextrin)

PLACEBO COMPARATOR

Isoenergetic, maltodextrin (7 day pre-loading phase and 3 day training phase)

Dietary Supplement: Placebo (maltodextrin)

Interventions

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)

Whey protein
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)

Soy protein
Placebo (maltodextrin)DIETARY_SUPPLEMENT

Isoenergetic placebo (maltodextrin) for 10 days (7 days pre-loading and 3 days during trials 1 and 2

Placebo (maltodextrin)

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • A known milk intolerance or allergy
  • A recent febrile illness
  • History of muscle lesion
  • Lower limb trauma
  • Metabolic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly

Trikala, 42100, Greece

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Whey ProteinsSoybean Proteinsmaltodextrin

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesPlant ProteinsPlant Proteins, DietarySoy FoodsVegetable ProductsVegetables

Study Officials

  • Savvas Kritikos, MScc

    UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 12, 2018

First Posted

November 26, 2018

Study Start

November 8, 2018

Primary Completion

January 20, 2019

Study Completion

February 20, 2019

Last Updated

November 24, 2020

Record last verified: 2020-11

Locations