The Effect of Postbiotics Supplementation on Exercise-induced Oxidative Stress. (PB-EIOS)

May 25, 2024 updated by: Chariklia K. Deli, University of Thessaly
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Athanasios Z Jamurtas, PhD
  • Phone Number: +302431047054
  • Email: ajamurt@pe.uth.gr

Study Locations

  • Greece
    • Thessaly
      • Trikala, Thessaly, Greece, 42100
        • Recruiting
        • Department of Physical Education and Sport Science, Uninersity of Thessaly
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Postbiotics supplementation
Supplementation of postbiotics for 4 weeks
Dietary supplement: Postbiotics supplementation
The participants will consume one capsule per day.
Placebo Comparator: Placebo supplementation
Supplementation of placebo for 4 weeks
Dietary supplement: Placebo supplementation
The participants will consume one capsule per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
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
At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
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
At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
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
At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
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
At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
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
At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
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
At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
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
At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
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
At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
Changes in blood lactate
Time Frame: At baseline (pre), and 4 min post-trial
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
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)
At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
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
At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise
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
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)
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
At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Thessaly

Investigators

  • Principal Investigator: Chariklia K Deli, PhD, University of Thessaly, DPESS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2024

Primary Completion (Estimated)

August 30, 2024

Study Completion (Estimated)

August 30, 2024

Study Registration Dates

First Submitted

May 7, 2024

First Submitted That Met QC Criteria

May 11, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2024

Last Update Submitted That Met QC Criteria

May 25, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • PostBiotics-Exercise

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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