Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417671
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-07
Brief Title:
The Effect of Postbiotics Supplementation on Exercise-induced Oxidative Stress
Sponsor:
University of Thessaly
Organization:
University of Thessaly
Study Overview
Official Title:
The Effect of Postbiotics Supplementation on Exercise-induced Oxidative Stress
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PB-EIOS
Brief Summary:
Scientific data on the effect of supplementation of postbiotics on exercise-induced oxidative stress are scarce The main purpose of the research is to investigate the effect of postbiotics supplementation on exercise-induced oxidative stress and performance indicators after intense exercise The study will be a cross-over randomized double-blind controlled study that will be conducted in two cycles Participants will be randomly assigned into one of the two trials i Postbiotics supplementation for 4 weeks ii Placebo supplementation for 4 weeks Participants will then perform a 45-min treadmill running at -15 slope 70 VO2max followed by a time-trial 0 slope 95 VO2max until exhaustion Before as well as 24 h 48 h and 72 h after the exercise participants will undergo measurements of exercise-induced muscle damage EIMD delayed onset of muscle soreness DOMS creatine kinase blood redox status total antioxidant capacity catalase protein carbonyls reduced glutathione oxidized glutathione and isokinetic performance knee-extensors and knee-flexors isometric concentric eccentric torque evaluation In addition metabolism lactic acid will be assessed before and 4 min after exercise Afterwards the participants will receive the postbiotics supplement or the placebo for 4 weeks and will repeat the exercise protocol and measurements of EIMD blood redox status and performance indices at the same time-points At the second cycle the participants will repeat the above procedures under the remaining condition Between conditions there will be a 14-day washout period The results of the research will provide important information for coaches and physically active individuals regarding the effectiveness of postbiotics in alleviating oxidative stress and improving performance after intense exercise
Detailed Description:
Acute vigorous andor unaccustomed exercise can induce muscle injury and oxidative stress At moderate concentrations reactive oxygen and nitrogen species RONS act as signaling molecules and promote adaptations to systematic training Conversely excessive production of RONS may cause destructive effects due to the oxidation of important biomolecules such as lipids and proteins but also DNA Disruption of the redox balance can bring about adverse effects on exercise-induced adaptations such as muscle damage and fatigue For this reason many professional as well as amateur athletes often consume nutritional supplements such as antioxidants anticipating to reduce inflammation and oxidative stress after intense exercise
The human gastrointestinal tract is inhabited by various microorganisms called the gut microbiome GM GM among other things contributes to the normal functioning of the immune system contributes to the production of short-chain fatty acids SCFAs and vitamin synthesis as well as the digestion and absorption of food protects against enteropathogens and regulates inflammatory and redox responses Recent evidence also suggests that GM may be involved in athletic performance In contrast disruption of GM composition dysbiosis is characterized by reduced diversity reduced abundance of health-promoting bacteria and increased abundance of gram-negative and other pathogenic bacteria and is associated with various metabolic diseases such as obesity diabetes and various forms of cancer systemic inflammation oxidative stress and reduced performance Thus the supplementation of several biotics has been emerged as a means to regulate the GM in favor of health-promoting bacteria
Postbiotics is defined as a preparation of inanimate microorganisms andor their components that confers a health benefit on the host Evidence suggests that supplementation with postbiotics may regulate the GM and consequently strengthen the immune system reduce intestinal permeability improve antioxidant mechanisms as well as accelerate recovery after exercise-induced inflammation enhance adaptations to exercise and improve performance However the scientific data regarding the possible beneficial effect of supplemental administration of postbiotics is limited More research is needed in order to determine the role of postbiotics supplementation on exercise-induced inflammation and redox status but also on performance after intense exercise
This study will investigate the potential of postbiotics supplementation to affect the recovery of exercise-induced oxidative stress and performance following intense eccentrically biased acute exercise
The study will be cross-over randomized double-blind controlled and will be conducted in two cycles The participants will be primarily informed of the study procedures as well as the benefits and possible risks they will also sign an informed consent form for participation in the study Before the experimental procedure they will be involved in a week of familiarization to the evaluation tests and the exercise protocol at a low intensity In addition the participants will record their diet via a 7-days recall before their participation in the first experimental condition and dietary data will be analyzed with ScienceFit Diet 200A diet analysis program Science Technologies Athens Greece in order to estimate that they do not consume nutrients that may affect muscle injury inflammation and oxidative stress eg antioxidants etc Baseline measurements will take place at the Laboratory of Biochemistry Physiology and Nutrition of Exercise SmArT Lab Department of Physical Education and Sports University of Thessaly anthropometric characteristics body height body mass body mass index via a stadiometer-scale Stadiometer 208 Seca Birmingham UK body composition amount of body fat lean body mass fat mass bone density via by dual emission X-ray absorptiometry DXA GE-Healthcare Lunar DPX NT Belgium aerobic capacity VO2max via an automated online pulmonary gas analyzer Vmax Encore 29 BEBJO296 Yorba Linda CA USA during a graded exercise protocol on a treadmill Stex 8025T Korea isokinetic strength isometric concentric and eccentric torque of the knee extensors and knee flexors on an isokinetic dynamometer Cybex HUMAC NORM 360 Ronkonkoma NY and muscle power via the assessment of countermovement jump CMJ via an optical measurement system Optojump next Microgate USA Participants will then be randomized in one of the two conditions i Postbiotics supplementation 50mgday of Heat-killed Lactobacillus plantarum L-137 Immuno-LP20TM for 4 weeks or ii placebo supplementation for 4 weeks Randomization of the conditions will be done by a software generating random integers available on the internet Randomorg Seven days later participants will perform an exercise protocol comprised of 45 min downhill running -15 slope 70-75 VO2max on a treadmill followed by a time-trial 0 slope 95 VO2max until exhaustion Before the exercise protocol as well as 24 h 48 h and 72 h after exercise delayed onset of muscle soreness DOMS via palpation of the knee extensors and knee flexors on a scale of 1 to 10 1 no pain at all 10 extreme pain and muscle performance CMJ isometric concentric and eccentric torque of the knee extensors and knee flexors will be assessed Additionally blood samples will be collected at the same time-points for the assessment of creatine kinase CK and blood redox status reduced glutathione GSH oxidized glutathione GSSG GSHGSSG ratio total antioxidant capacity TAC catalase CAT protein carbonyls PC uric acid bilirubin Furthermore metabolism lactic acid will be assessed before and 4 min after exercise by analyzing capillary blood with a portable lactate analyzer Lactate Plus Nova Biomedical USA After a 14-days washout period participants will repeat the exact same procedures for the remaining condition in the second cycle Additionally the 7-day diet recall will be given to the participants to follow the same diet before the experimental exercise protocol at the second cycle
The human gastrointestinal tract is inhabited by various microorganisms called the gut microbiome GM GM among other things contributes to the normal functioning of the immune system contributes to the production of short-chain fatty acids SCFAs and vitamin synthesis as well as the digestion and absorption of food protects against enteropathogens and regulates inflammatory and redox responses Recent evidence also suggests that GM may be involved in athletic performance In contrast disruption of GM composition dysbiosis is characterized by reduced diversity reduced abundance of health-promoting bacteria and increased abundance of gram-negative and other pathogenic bacteria and is associated with various metabolic diseases such as obesity diabetes and various forms of cancer systemic inflammation oxidative stress and reduced performance Thus the supplementation of several biotics has been emerged as a means to regulate the GM in favor of health-promoting bacteria
Postbiotics is defined as a preparation of inanimate microorganisms andor their components that confers a health benefit on the host Evidence suggests that supplementation with postbiotics may regulate the GM and consequently strengthen the immune system reduce intestinal permeability improve antioxidant mechanisms as well as accelerate recovery after exercise-induced inflammation enhance adaptations to exercise and improve performance However the scientific data regarding the possible beneficial effect of supplemental administration of postbiotics is limited More research is needed in order to determine the role of postbiotics supplementation on exercise-induced inflammation and redox status but also on performance after intense exercise
This study will investigate the potential of postbiotics supplementation to affect the recovery of exercise-induced oxidative stress and performance following intense eccentrically biased acute exercise
The study will be cross-over randomized double-blind controlled and will be conducted in two cycles The participants will be primarily informed of the study procedures as well as the benefits and possible risks they will also sign an informed consent form for participation in the study Before the experimental procedure they will be involved in a week of familiarization to the evaluation tests and the exercise protocol at a low intensity In addition the participants will record their diet via a 7-days recall before their participation in the first experimental condition and dietary data will be analyzed with ScienceFit Diet 200A diet analysis program Science Technologies Athens Greece in order to estimate that they do not consume nutrients that may affect muscle injury inflammation and oxidative stress eg antioxidants etc Baseline measurements will take place at the Laboratory of Biochemistry Physiology and Nutrition of Exercise SmArT Lab Department of Physical Education and Sports University of Thessaly anthropometric characteristics body height body mass body mass index via a stadiometer-scale Stadiometer 208 Seca Birmingham UK body composition amount of body fat lean body mass fat mass bone density via by dual emission X-ray absorptiometry DXA GE-Healthcare Lunar DPX NT Belgium aerobic capacity VO2max via an automated online pulmonary gas analyzer Vmax Encore 29 BEBJO296 Yorba Linda CA USA during a graded exercise protocol on a treadmill Stex 8025T Korea isokinetic strength isometric concentric and eccentric torque of the knee extensors and knee flexors on an isokinetic dynamometer Cybex HUMAC NORM 360 Ronkonkoma NY and muscle power via the assessment of countermovement jump CMJ via an optical measurement system Optojump next Microgate USA Participants will then be randomized in one of the two conditions i Postbiotics supplementation 50mgday of Heat-killed Lactobacillus plantarum L-137 Immuno-LP20TM for 4 weeks or ii placebo supplementation for 4 weeks Randomization of the conditions will be done by a software generating random integers available on the internet Randomorg Seven days later participants will perform an exercise protocol comprised of 45 min downhill running -15 slope 70-75 VO2max on a treadmill followed by a time-trial 0 slope 95 VO2max until exhaustion Before the exercise protocol as well as 24 h 48 h and 72 h after exercise delayed onset of muscle soreness DOMS via palpation of the knee extensors and knee flexors on a scale of 1 to 10 1 no pain at all 10 extreme pain and muscle performance CMJ isometric concentric and eccentric torque of the knee extensors and knee flexors will be assessed Additionally blood samples will be collected at the same time-points for the assessment of creatine kinase CK and blood redox status reduced glutathione GSH oxidized glutathione GSSG GSHGSSG ratio total antioxidant capacity TAC catalase CAT protein carbonyls PC uric acid bilirubin Furthermore metabolism lactic acid will be assessed before and 4 min after exercise by analyzing capillary blood with a portable lactate analyzer Lactate Plus Nova Biomedical USA After a 14-days washout period participants will repeat the exact same procedures for the remaining condition in the second cycle Additionally the 7-day diet recall will be given to the participants to follow the same diet before the experimental exercise protocol at the second cycle
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None