Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06428656
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-20
Brief Title:
Postbiotics Supplementation Gut Microbiota Composition and Exercise-induced Inflammation
Sponsor:
University of Thessaly
Organization:
University of Thessaly
Study Overview
Official Title:
The Effect of Postbiotics Supplementation on Gut Microbiota Composition and Exercise-induced Inflammation
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:
PostBioExIn
Brief Summary:
This study will investigate the effect of postbiotics supplementation on gut microbiota GM composition exercise-induced oxidative stress and performance following eccentrically biased 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 following exercise assessment of GM composition and metabolites short-chain fatty acids exercise induced muscle damage EIMD delayed onset of muscle soreness creatine kinase complete blood count CBC blood inflammatory status tumor necrosis factor alpha interleukin 6 C-reactive protein gut inflammatory status lipopolysacharides-binding protein zonulin blood redox status total antioxidant capacity catalase protein carbonyls reduced glutathione oxidized glutathione and performance knee-extensors and knee-flexors isometric concentric eccentric torque countermovement jump will be performed In addition metabolism lactic acid will be assessed before and 4 min following 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 CBC blood inflammatory status blood redox status and performance 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 to favorably change the gut microbiota composition and alleviate gut inflammation exercise-induced inflammation and oxidative stress and improve performance after intense exercise
Detailed Description:
Acute vigorous andor unaccustomed eccentric exercise can induce muscle injury and inflammatory reactions and oxidative stress but also reduced muscle performance 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 GM composition and function exercise-induced inflammation and redox status but also on performance after intense exercise
This study will investigate the potential of postbiotics supplementation to alter the GM composition and 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 regarding the study procedures as well as the benefits and possible risks and will 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 Participants will undergo baseline measurements 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 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 Participants will then be randomized in one of the two conditions i Postbiotics supplementation 50mgday of Heatkilled 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 Participants will then 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 exercise-induced muscle damage EIMD 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 At the same time points feces samples will be collected for the analysis of GM composition and function and GM metabolites as well as blood samples for the assessment of complete blood count CBC blood inflammatory status creatine kinase tumor necrosis factor alpha interleukin 6 C-reactive protein gut inflammatory status lipopolysacharides-binding protein zonulin and blood redox status reduced glutathione GSH oxidized glutathione GSSG GSHGSSG ratio total antioxidant capacity catalase protein carbonyls uric acid bilirubin Furthermore metabolism lactic acid will be assessed before and 4 min following exercise by analyzing capillary blood with a portable lactate analyzer Lactate Plus Nova Biomedical USA Afterwards the participants will receive the postbiotics supplement or the placebo for 4 weeks and will repeat the exercise protocol and measurements of EIMD CBC blood inflammatory status blood redox status and performance at the same time-points At the second cycle participants will repeat the exact same procedures for the remaining condition Between cycles a 14-days washout period will be applied Additionally the 7-day diet recall from the first cycle 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 GM composition and function exercise-induced inflammation and redox status but also on performance after intense exercise
This study will investigate the potential of postbiotics supplementation to alter the GM composition and 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 regarding the study procedures as well as the benefits and possible risks and will 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 Participants will undergo baseline measurements 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 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 Participants will then be randomized in one of the two conditions i Postbiotics supplementation 50mgday of Heatkilled 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 Participants will then 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 exercise-induced muscle damage EIMD 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 At the same time points feces samples will be collected for the analysis of GM composition and function and GM metabolites as well as blood samples for the assessment of complete blood count CBC blood inflammatory status creatine kinase tumor necrosis factor alpha interleukin 6 C-reactive protein gut inflammatory status lipopolysacharides-binding protein zonulin and blood redox status reduced glutathione GSH oxidized glutathione GSSG GSHGSSG ratio total antioxidant capacity catalase protein carbonyls uric acid bilirubin Furthermore metabolism lactic acid will be assessed before and 4 min following exercise by analyzing capillary blood with a portable lactate analyzer Lactate Plus Nova Biomedical USA Afterwards the participants will receive the postbiotics supplement or the placebo for 4 weeks and will repeat the exercise protocol and measurements of EIMD CBC blood inflammatory status blood redox status and performance at the same time-points At the second cycle participants will repeat the exact same procedures for the remaining condition Between cycles a 14-days washout period will be applied Additionally the 7-day diet recall from the first cycle 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