The Effect of Probiotics and Vitamin D Supplementation on Sport Performance in MMA Athletes.

NCT04759729 | Unknown

• 1 other identifier: MMA29012021
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The probiotics supplementation seems to be safety way to optimize the intestinal microbiota composition and thus modulate the immune system and reduce oxidative stress. Moreover it may enhance muscle protein synthesis, mitochondrial biogenesis and function, as well as muscle glycogen storage. Probiotics intake via reduce inflammatory markers and reactive oxygen species production may attenuate macromolecules damage and have some beneficial effect on aerobic and anaerobic performance. The combined probiotics and vitamin D supplementation may enhance this effect. The synergistic intestinal microbiota and vitamin D interaction towards muscle protein synthesis and mitochondrial function improvement may be manifested by mTOR and FOXO signaling influence on oxidative stress as well as immunological functions modulation. In the study investigators will assess if multistrain probiotic mixture in conjunction with vitamin D may have beneficial effect on sport performance among trained male mixed-martial arts athletes. The study protocol is designed as a randomized double-blind placebo-controlled clinical trial. Researchers are going to evaluate changes in the gut, including microbiome composition and epithelial permeability; differences in the blood parameters as well as direct influence on sport performance, expressed by anaerobic and aerobic fitness capacity. Researchers will provide an evidences, having both theoretical as well as practical aspect.

Conditions

Gut Microbiome; Sport Performance

Keywords

microbiota; sport performance; mixed-martial arts; microbiome; vitamin D

Outcome Measures

Primary Outcomes (8)

• Evaluation of changes in gut microbiome composition caused by intervention.

  Collected stool samples will be assessed with new generation sequencing method. Selected hypervariable regions of the 16SrRNA gene will be analyzed. The composition of the microbiome will be characterized primarily by alpha and beta diversity. Diversity of microbial communities in one sample (alpha) will be measured using several indicators, such as Chao1, ACE, Shannon and inverted Simpson. During the analysis investigators will assess presence of short-chain fatty acid.

  Participants will be obligated to deliver a stool samples at the baseline and follow up visit. The outcome measure will be assessed up to 9 months

• Evaluation of changes in the gut on epithelial permeability

  Collected stool samples will be assessed in the context intestine barrier permeability as zonulin, calprotectin and FABP.

  Participants will be obligated to deliver a stool samples at the baseline and follow up visit. The outcome measure will be assessed up to 9 months

• Assessment of changes in body composition c.used by intervention,

  The body composition analysis will be evaluated to detect potential changes within body fat mass and fat free mass. The level of each tissue will be compared to intestinal bacteria content. Investigators will try to explain if gut microbiome composition and vitamin D may affect body composition and which bacterial phyla are responsible for possible for this potential changes. This target will be obtain through multi-frequency bioelectrical impedance anap visit (before sport tests, before breakfast). The outcome measure will be assessed up to 1 month (BIA)

  The measurement will be perform in the morning, at baseline and follow up visit (before sport tests, before breakfast). The outcome measure will be assessed up to 1 month.

• The effect of probiotics and vitamin D supplementation on inflammatory state- the evaluation on changes between baseline and follow up visit.

  The collected venous blood samples will be subjected to analysis at the Medical The effect of probiotics and vitamin D supplementation on inflammatory state - the evaluation on changes between baseline and follow up visit. The outcome measure will be assessed up to 6 monthsUniversity of Gdańsk. Investigators will assess the level of serum pro-inflammatory cytokines (IL-6 and TNF-α) as well as anti-inflammatory cytokines (L-2 and IL-15) using a commercially available enzyme-linked immunosorbent assay (ELISA) kits.

  The arm vein blood will be collected at baseline as well as follow up visit at three time points - before breakfast and sport tests, 35 minutes after anaerobic tests and 24 hours after Wingate test. The outcome measure will be assessed up to 6 months

• The effect of probiotics and vitamin D supplementation on muscle damage - the evaluation on changes between baseline and follow up visit.

  The collected venous blood samples will be subjected to analysis at the Medical University of Gdańsk.Investigators will assess changes in creatine kinase level through kinetic method, using the commercially available kit.

  The arm vein blood will be collected at baseline visit at three time points - before breakfast and sport tests, 35 minutes after anaerobic tests and 24 hours after Wingate test. The outcome measure will be assessed up to 6 months .

• Effect of probiotics and vitamin D supplementation on aerobic sport performance - evaluation of changes

  To assess an effect on aerobic sport performance investigators will perform aerobic (cardio-pulmonary exercise test) as well as anaerobic test (triple Wingate test) using cycloergometer. Additionally the capillary blood will be collected to assess the level of lactate concentration as well as rate of lactate utilization.

  Aerobic test will be perform 3-5 days before/after anaerobic test. The outcome measure will be assessed up to 3 months.

• Effect of probiotics and vitamin D supplementation on anaerobic sport performance - evaluation of changes

  To assess an effect on sport performance investigators will perform anaerobic triple Wingate test using cycloergometer.

  The Wingate test will be perform at baseline and follow up visit. The outcome measure will be assessed up to 3 months .

• Effect of probiotics and vitamin D supplementation on lactate utilization - evaluation of changes

  The capillary blood will be collected to assess the level of lactate concentration as well as rate of lactate utilization.

  Capillary blood will be collected in 5 time points, directly before Wingate test, 3, 15, 30 and 60 minutes after test.The outcome measure will be assessed up to 3 months

Study Arms (2)

PRO+D group

EXPERIMENTAL

Participants will receive probiotic as well as vitamin D supplementation.

Combination Product: Probiotic and vitamin D

PL+D group

EXPERIMENTAL

Participants will receive placebo instead of probiotics and vitamin D supplementation.

Dietary Supplement: placebo and vitamin D

Interventions

Probiotic and vitamin D COMBINATION_PRODUCT

Participants enrolled to PRO + D group will receive probiotics and vitamin D supplements as a intervention product. Participants enrolled to probiotic group will receive probiotics as well as vitamin D supplements.

PRO+D group

placebo and vitamin D DIETARY_SUPPLEMENT

Participants enrolled to PL+D group will receive vitamin D. Additionally they will get placebo instead of probiotics.

PL+D group

Eligibility Criteria

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

You may qualify if:

• age ≥ 18
• male gender
• signed informed consent
• minimum 3 years of mixed martial arts training practice
• realization of minimum 5 workouts weekly
• participation in 2 competitions at least

You may not qualify if:

• age below 18
• female gender
• lack of signed informed consent
• antibiotic therapy during last 3 months
• diagnosed inflammatory bowel disease
• chronic musculoskeletal injuries within last 6 months
• heart failure or defects

Sponsors & Collaborators

• Medical University of Gdansk: lead
• Gdansk University of Physical Education and Sport: collaborator
• Pomeranian Medical University Szczecin: collaborator

Study Sites (1)

Medical University of Gdańsk

Gdansk, Pomeranian, 80-210, Poland

Location

MeSH Terms

Interventions

Probiotics; Vitamin D

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Katarzyna KP Przewłócka, MSc

  Medical University of Gdańsk, Gdańsk, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2021
• First Posted: February 18, 2021
• Study Start: December 1, 2020
• Primary Completion: February 28, 2021
• Study Completion: March 31, 2021
• Last Updated: February 18, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)