The Effect of Postbiotics Supplementation on Exercise-induced Oxidative Stress.

NCT06417671 | Completed

• 1 other identifier: PostBiotics-Exercise
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Postbiotics Supplement

Outcome Measures

Primary Outcomes (14)

• Changes in PC

  Concentration of PC will be measured in plasma

  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

  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

  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

  At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise

• Changes in GSH/GSSG ratio

  GSH/GSSG ratio will be calculated

  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

  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

  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

  At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise

• Changes in bilirubin

  Concentration of bilirubin will be measured in plasma

  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

  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)

  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

  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

  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

  At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise

Study Arms (2)

Postbiotics supplementation

EXPERIMENTAL

Supplementation of postbiotics for 4 weeks

Dietary Supplement: Postbiotics supplementation

Placebo supplementation

PLACEBO COMPARATOR

Supplementation of placebo for 4 weeks

Dietary Supplement: Placebo supplementation

Interventions

Postbiotics supplementation DIETARY_SUPPLEMENT

The participants will consume one capsule per day.

Postbiotics supplementation

Placebo supplementation DIETARY_SUPPLEMENT

The participants will consume one capsule per day.

Placebo supplementation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

Department of Physical Education and Sport Science, Uninersity of Thessaly

Trikala, Thessaly, 42100, Greece

Location

Related Publications (8)

• 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.

  PMID: 24068487 RESULT

• Deli 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.

  PMID: 28203319 RESULT

• Deli 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.

  PMID: 29469654 RESULT

• Human Microbiome Project Consortium. Structure, function and diversity of the healthy human microbiome. Nature. 2012 Jun 13;486(7402):207-14. doi: 10.1038/nature11234.

  PMID: 22699609 RESULT

• Sales 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.

  PMID: 36089243 RESULT

• Jager 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.

  PMID: 31864419 RESULT

• Salminen 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.

  PMID: 33948025 RESULT

• Lee 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.

  PMID: 36363775 RESULT

Study Officials

• Chariklia K Deli, PhD

  University of Thessaly, DPESS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The randomization of the participants to the supplement or placebo condition will be performed via a random integer set generator (Random.org) available online. Neither the participants, nor the supplement provider will be aware of whether participants receive the postbiotic supplement or the placebo. Additionally, blood samples will be masked during the biochemical analysis, and during the statistical analysis.
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 16, 2024
• Study Start: May 15, 2024
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)