Postbiotics SupplementPB-EIOSNCT06417671
The Effect of Postbiotics Supplementation on Exercise-induced Oxidative Stress.
A study testing Postbiotics supplementation in people with Postbiotics Supplement, run by University of Thessaly at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Postbiotics Supplement
- What is being tested?
- Postbiotics supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteGreece
- Study dates
- 15 May 2024to 30 Aug 2024
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Physically active subjects (VO2max ≥35ml/kg/min)
- Absence of musculoskeletal injury (≥6 months)
- Abstinence from the use of ergogenic supplements (≥1 month)
- Abstinence from anti-inflammatory drugs (≥1 month)
- Abstinence from pre-pro-postbiotic supplements (≥6 months)
- Abstinence from participating in exercise with eccentric content for at least 7 days before exercise
- Abstinence from alcohol and energy drinks before exercise
Who cannot join
- Recent history of musculoskeletal injury (<6 months)
- Use of ergogenic performance supplements (<1 month)
- Taking anti-inflammatory drugs (<1 month)
- Taking pre-pro-postbiotic supplements (<6 months)
- Participation in exercise with eccentric content in the previous 7 days before exercise
- Consumption of alcohol and energy drinks before exercise
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Physical Education and Sport Science, Uninersity of Thessaly
Trikala, Thessaly, 42100
About this study
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.
Read the detailed description
Acute, vigorous and/or 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 and/or 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 (e.g. 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 (50mg/day 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 (Random.org). 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), GSH/GSSG 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.
- Conditions
- Postbiotics Supplement
- Being tested
- Postbiotics supplementation, Placebo supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postbiotics supplementationDietary supplement
The participants will consume one capsule per day.
Placebo supplementationDietary supplement
The participants will consume one capsule per day.
| Study group | Role | What they receive |
|---|---|---|
| Postbiotics supplementation | Experimental | Supplementation of postbiotics for 4 weeks Receives: Dietary Supplement: Postbiotics supplementation |
| Placebo supplementation | Placebo comparator | Supplementation of placebo for 4 weeks Receives: Dietary Supplement: Placebo supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in PC
Concentration of PC will be measured in plasma
Measured: At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
Changes in malondialdehyde (MDA)
Concentration of MDA will be measured in plasma
Measured: At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
Changes in reduced glutathione (GSH)
Concentration of GSH will be measured in red blood cells
Measured: At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
Changes in oxidized glutathione (GSSG)
Concentration of GSSG will be measured in red blood cells
Measured: At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
Changes in GSH/GSSG ratio
GSH/GSSG ratio will be calculated
Measured: At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
Changes in catalase
Concentration of catalase will be measured in red blood cells
Measured: At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
Changes in total antioxidant capacity (TAC)
TAC will be measured in plasma
Measured: At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
Changes in uric acid
Concentration of uric acid will be measured in plasma
Measured: At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
Changes in bilirubin
Concentration of bilirubin will be measured in plasma
Measured: At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
Changes in blood lactate
Concentration of lactate will be measured in capillary blood
Measured: At baseline (pre), and 4 min post-trial
Changes in in delayed onset of muscle soreness (DOMS) in the knee flexors (KF) and extensors (KE) of both limbs
Muscle soreness of the KF and KE will be assessed via palpation of the muscle belly and the distal regions following 3 squats, and the subjective pain will be recorded on a 10-point scale (1 = no pain, 10 = extreme pain)
Measured: At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
Changes in creatine kinase (CK)
CK will be will be measured in serum
Measured: At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
Changes in countermovement jump (CMJ) height
CMJ height will be measured with an optical system
Measured: At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
Changes in isokinetic strength of knee extensors (KE) and knee flexors (KF)
Isometric, concentric and eccentric peak torque of the KE and KF of both limbs will be assessed on an isokinetic dynamometer
Measured: At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start15 May 2024
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Postbiotics SupplementStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chariklia K. Deli, University of Thessaly
- Investigators
- Chariklia K Deli, PhD, Principal investigator, University of Thessaly, DPESS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417671
- Sponsor's protocol ID
- PostBiotics-Exercise
- Acronym
- PB-EIOS
- Status last verified
- Dec 2024
- First submitted
- 7 May 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jamurtas AZ, Garyfallopoulou A, Theodorou AA, Zalavras A, Paschalis V, Deli CK, Nikolaidis MG, Fatouros IG, Koutedakis Y. A single bout of downhill running transiently increases HOMA-IR without altering adipokine response in healthy adult women. Eur J Appl Physiol. 2013 Dec;113(12):2925-32. doi: 10.1007/s00421-013-2717-5. Epub 2013 Sep 26.
PubMed 24068487Deli CK, Fatouros IG, Paschalis V, Tsiokanos A, Georgakouli K, Zalavras A, Avloniti A, Koutedakis Y, Jamurtas AZ. Iron Supplementation Effects on Redox Status following Aseptic Skeletal Muscle Trauma in Adults and Children. Oxid Med Cell Longev. 2017;2017:4120421. doi: 10.1155/2017/4120421. Epub 2017 Jan 22.
PubMed 28203319Deli CK, Poulios A, Georgakouli K, Papanikolaou K, Papoutsis A, Selemekou M, Karathanos VT, Draganidis D, Tsiokanos A, Koutedakis Y, Fatouros IG, Jamurtas AZ. The effect of pre-exercise ingestion of corinthian currant on endurance performance and blood redox status. J Sports Sci. 2018 Oct;36(19):2172-2180. doi: 10.1080/02640414.2018.1442781. Epub 2018 Feb 22.
PubMed 29469654Human Microbiome Project Consortium. Structure, function and diversity of the healthy human microbiome. Nature. 2012 Jun 13;486(7402):207-14. doi: 10.1038/nature11234.
PubMed 22699609Sales KM, Reimer RA. Unlocking a novel determinant of athletic performance: The role of the gut microbiota, short-chain fatty acids, and "biotics" in exercise. J Sport Health Sci. 2023 Jan;12(1):36-44. doi: 10.1016/j.jshs.2022.09.002. Epub 2022 Sep 9.
PubMed 36089243Jager R, Mohr AE, Carpenter KC, Kerksick CM, Purpura M, Moussa A, Townsend JR, Lamprecht M, West NP, Black K, Gleeson M, Pyne DB, Wells SD, Arent SM, Smith-Ryan AE, Kreider RB, Campbell BI, Bannock L, Scheiman J, Wissent CJ, Pane M, Kalman DS, Pugh JN, Ter Haar JA, Antonio J. International Society of Sports Nutrition Position Stand: Probiotics. J Int Soc Sports Nutr. 2019 Dec 21;16(1):62. doi: 10.1186/s12970-019-0329-0.
PubMed 31864419Salminen S, Collado MC, Endo A, Hill C, Lebeer S, Quigley EMM, Sanders ME, Shamir R, Swann JR, Szajewska H, Vinderola G. The International Scientific Association of Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of postbiotics. Nat Rev Gastroenterol Hepatol. 2021 Sep;18(9):649-667. doi: 10.1038/s41575-021-00440-6. Epub 2021 May 4.
PubMed 33948025Lee CC, Liao YC, Lee MC, Cheng YC, Chiou SY, Lin JS, Huang CC, Watanabe K. Different Impacts of Heat-Killed and Viable Lactiplantibacillus plantarum TWK10 on Exercise Performance, Fatigue, Body Composition, and Gut Microbiota in Humans. Microorganisms. 2022 Nov 3;10(11):2181. doi: 10.3390/microorganisms10112181.
PubMed 36363775
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Postbiotics Supplementation on Exercise-induced Oxidative Stress.
- ClinicalTrials.gov ID
- NCT06417671
- Acronym / sponsor ID
- PB-EIOS / PostBiotics-Exercise
- Conditions
- Postbiotics Supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 16 May 2024 (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.
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 and/or 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 and/or 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 (e.g. 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 (50mg/day 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 (Random.org). 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), GSH/GSSG 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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postbiotics supplementation | Experimental | Dietary Supplement: Postbiotics supplementationSupplementation of postbiotics for 4 weeks |
| Placebo supplementation | Placebo comparator | Dietary Supplement: Placebo supplementationSupplementation of placebo for 4 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Physically active subjects (VO2max ≥35ml/kg/min)
- Absence of musculoskeletal injury (≥6 months)
- Abstinence from the use of ergogenic supplements (≥1 month)
- Abstinence from anti-inflammatory drugs (≥1 month)
- Abstinence from pre-pro-postbiotic supplements (≥6 months)
Key exclusion criteria (6 listed)
- Recent history of musculoskeletal injury (<6 months)
- Use of ergogenic performance supplements (<1 month)
- Taking anti-inflammatory drugs (<1 month)
- Taking pre-pro-postbiotic supplements (<6 months)
- Participation in exercise with eccentric content in the previous 7 days before exercise
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 |
|---|---|---|
| Postbiotics supplementationThe participants will consume one capsule per day. | Dietary supplement | Postbiotics supplementation |
| Placebo supplementationThe participants will consume one capsule per day. | Dietary supplement | Placebo supplementation |
Primary outcome
Changes in PC
Time frame: At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
Concentration of PC will be measured in plasma
Changes in malondialdehyde (MDA)
Time frame: At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
Concentration of MDA will be measured in plasma
Changes in reduced glutathione (GSH)
Time frame: At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
Concentration of GSH will be measured in red blood cells
Changes in oxidized glutathione (GSSG)
Time frame: At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
Concentration of GSSG will be measured in red blood cells
Changes in GSH/GSSG ratio
Time frame: At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
GSH/GSSG ratio will be calculated
Changes in catalase
Time frame: At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
Concentration of catalase will be measured in red blood cells
Changes in total antioxidant capacity (TAC)
Time frame: At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
TAC will be measured in plasma
Changes in uric acid
Time frame: At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
Concentration of uric acid will be measured in plasma
Changes in bilirubin
Time frame: At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
Concentration of bilirubin will be measured in plasma
Changes in blood lactate
Time frame: At baseline (pre), and 4 min post-trial
Concentration of lactate will be measured in capillary blood
Changes in in delayed onset of muscle soreness (DOMS) in the knee flexors (KF) and extensors (KE) of both limbs
Time frame: At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
Muscle soreness of the KF and KE will be assessed via palpation of the muscle belly and the distal regions following 3 squats, and the subjective pain will be recorded on a 10-point scale (1 = no pain, 10 = extreme pain)
Changes in creatine kinase (CK)
Time frame: At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
CK will be will be measured in serum
Changes in countermovement jump (CMJ) height
Time frame: At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
CMJ height will be measured with an optical system
Changes in isokinetic strength of knee extensors (KE) and knee flexors (KF)
Time frame: At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
Isometric, concentric and eccentric peak torque of the KE and KF of both limbs will be assessed on an isokinetic dynamometer
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 4 Dec 2024.
- Results publication: PubMed 24068487Jamurtas AZ, Garyfallopoulou A, Theodorou AA, Zalavras A, Paschalis V, Deli CK, Nikolaidis MG, Fatouros IG, Koutedakis Y. A single bout of downhill running transiently increases HOMA-IR without altering adipokine response in healthy adult women. Eur J Appl Physiol. 2013 Dec;113(12):2925-32. doi: 10.1007/s00421-013-2717-5. Epub 2013 Sep 26.
- Results publication: PubMed 28203319Deli CK, Fatouros IG, Paschalis V, Tsiokanos A, Georgakouli K, Zalavras A, Avloniti A, Koutedakis Y, Jamurtas AZ. Iron Supplementation Effects on Redox Status following Aseptic Skeletal Muscle Trauma in Adults and Children. Oxid Med Cell Longev. 2017;2017:4120421. doi: 10.1155/2017/4120421. Epub 2017 Jan 22.
- Results publication: PubMed 29469654Deli CK, Poulios A, Georgakouli K, Papanikolaou K, Papoutsis A, Selemekou M, Karathanos VT, Draganidis D, Tsiokanos A, Koutedakis Y, Fatouros IG, Jamurtas AZ. The effect of pre-exercise ingestion of corinthian currant on endurance performance and blood redox status. J Sports Sci. 2018 Oct;36(19):2172-2180. doi: 10.1080/02640414.2018.1442781. Epub 2018 Feb 22.
- Results publication: PubMed 22699609Human Microbiome Project Consortium. Structure, function and diversity of the healthy human microbiome. Nature. 2012 Jun 13;486(7402):207-14. doi: 10.1038/nature11234.
- Results publication: PubMed 36089243Sales KM, Reimer RA. Unlocking a novel determinant of athletic performance: The role of the gut microbiota, short-chain fatty acids, and "biotics" in exercise. J Sport Health Sci. 2023 Jan;12(1):36-44. doi: 10.1016/j.jshs.2022.09.002. Epub 2022 Sep 9.
- Results publication: PubMed 31864419Jager R, Mohr AE, Carpenter KC, Kerksick CM, Purpura M, Moussa A, Townsend JR, Lamprecht M, West NP, Black K, Gleeson M, Pyne DB, Wells SD, Arent SM, Smith-Ryan AE, Kreider RB, Campbell BI, Bannock L, Scheiman J, Wissent CJ, Pane M, Kalman DS, Pugh JN, Ter Haar JA, Antonio J. International Society of Sports Nutrition Position Stand: Probiotics. J Int Soc Sports Nutr. 2019 Dec 21;16(1):62. doi: 10.1186/s12970-019-0329-0.
- Results publication: PubMed 33948025Salminen S, Collado MC, Endo A, Hill C, Lebeer S, Quigley EMM, Sanders ME, Shamir R, Swann JR, Szajewska H, Vinderola G. The International Scientific Association of Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of postbiotics. Nat Rev Gastroenterol Hepatol. 2021 Sep;18(9):649-667. doi: 10.1038/s41575-021-00440-6. Epub 2021 May 4.
- Results publication: PubMed 36363775Lee CC, Liao YC, Lee MC, Cheng YC, Chiou SY, Lin JS, Huang CC, Watanabe K. Different Impacts of Heat-Killed and Viable Lactiplantibacillus plantarum TWK10 on Exercise Performance, Fatigue, Body Composition, and Gut Microbiota in Humans. Microorganisms. 2022 Nov 3;10(11):2181. doi: 10.3390/microorganisms10112181.
- Individual participant dataSharing planned: No
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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.
Chariklia K Deli, PhD principal investigator
University of Thessaly, DPESS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postbiotics supplementation in people with Postbiotics Supplement, 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 7 inclusion and 6 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 4 Dec 2024. 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?
Changes in PC (time frame: At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise). The study lists 14 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 NCT06417671, which also lists 8 linked publications.
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 4 Dec 2024.