Postbiotics Supplementation, Gut Microbiota Composition, and Exercise-induced Inflammation

NCT06428656 | Completed

• 1 other identifier: PB-GM-Exercise-Inflammation
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Postbiotics Supplementation

Outcome Measures

Primary Outcomes (24)

• Changes in gut microbiota composition

  Gut microbiota composition will be assessed in feces

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

• Changes in butyrate

  Butyrate will be assessed in feces

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

• Changes in propionate

  Propionate will be assessed in feces

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

• Changes in acetate

  Acetate will be assessed in feces

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

• Changes in complete blood count

  Complete blood count will be assessed in whole blood

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

• Changes in creatine kinase activity

  Creatine kinase activity will be assessed in serum

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

• Changes in TNF-α concentration

  TNF-α concentration will be assessed in serum

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

• Changes in IL-6 concentration

  IL-6 concentration will be assessed in serum

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

• Changes in high-sensitivity C-reactive protein concentration

  C-reactive protein concentration will be assessed in serum

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

• Changes in lipopolysacharides-binding protein concentration

  Lipopolysacharides-binding protein concentration will be assessed in serum

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

• Changes in zonulin concentration

  Zonulin concentration will be assessed in serum and in feces

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

• Changes in protein carbonyls concentration

  Protein carbonyls concentration will be assessed in plasma

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

• Changes in malondialdehyde concentration

  Malondialdehyde concentration will be assessed in plasma

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

• Changes in reduced glutathione concentration

  Glutathione concentration will be assessed in red blood cells lycate

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

• Changes in oxidized glutathione concentration

  Oxidized glutathione concentration will be assessed in red blood cells lycate

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

• Changes in GSH/GSSG ratio

  GSH/GSSG ratio will be assessed in red blood cells lycate

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

• Changes in catalase concentration

  Catalase concentration will be assessed in red blood cells lycate

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

• Changes in total antioxidant capacity

  Total antioxidant capacity will be assessed in red blood cells lycate

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

• Changes in uric acid concentration

  Uric acid concentration will be assessed in serum

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

• Changes in bilirubin concentration

  Bilirubin concentration will be assessed in serum

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

• Changes in blood lactate concentration

  Bilirubin concentration will be assessed in whole blood

  At baseline (pre), 4 min post-exercise

• Changes in delayed onset of muscle soreness in the knee flexors and extensors 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 countermovement jump height

  Countermovement jump 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 and knee flexors

  Isometric, concentric and eccentric peak torque of the knee extensors and knee flexors 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

Placebo supplementation DIETARY_SUPPLEMENT

The participants will consume one capsule of placebo per day

Placebo supplementation

Postbiotics supplementation DIETARY_SUPPLEMENT

The participants will consume one capsule of postbiotics supplement per day

Postbiotics 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

Study Officials

• Chariklia K Deli, PhD

  University of Thessaly

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, 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 care provider, nor the investigator 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 20, 2024
• First Posted: May 24, 2024
• Study Start: June 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

GR (1)