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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03753321
Other study ID # WHEY vs SOY PROTEIN - UTH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 8, 2018
Est. completion date February 20, 2019

Study information

Verified date November 2020
Source University of Thessaly
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Description:

A randomized, three-trial (placebo vs. whey protein isolate vs. soy protein isolate consumption), cross-over, double-blind design. 1. Baseline performance testing: Initially, volunteers will participate in a performance testing procedure at University facilities. These measurements include: A) 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). B) 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)]. 2. 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. 3. 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). 4. Wash-out period: 2-week without any activity or supplementation. 5. 2nd trial: repeat of stages 3 and 4. 6. 3rd trial: repeat of stage 3.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date February 20, 2019
Est. primary completion date January 20, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - A known milk intolerance or allergy - A recent febrile illness - History of muscle lesion - Lower limb trauma - Metabolic diseases.

Study Design


Intervention

Dietary Supplement:
Whey protein
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 protein
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)
Isoenergetic placebo (maltodextrin) for 10 days (7 days pre-loading and 3 days during trials 1 and 2

Locations

Country Name City State
Greece Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly Tríkala

Sponsors (1)

Lead Sponsor Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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.
Primary 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
Primary 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
Primary 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
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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 Dietary intake Dietary intake will be assessed using 7-day diet recalls. Over a 7-day period at baseline.
Secondary Concentration of blood lactate Blood lactate will be measured using an automatic analyzer Pre- and Post-SEPT session 1 (Day 8), Pre- and Post-SEPT session 2 (Day 10)
Secondary Change in habitual physical activity Physical activity will be measured using 3-axial accelerometers Over a 7-day period at baseline
Secondary Change in resting metabolic rate (RMR) RMR will be measured using open-circuit indirect calorimeter with a ventilated hood system, after an overnight fast. At baseline.
Secondary Change in body composition Body composition will be assessed using dual-energy X-ray absorptiometry (DXA). At baseline.
Secondary 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. At baseline.
Secondary 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). At baseline.
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