Analysis of the Impact of Used Probiotic Strains and Diet on Body Composition, Cardiopulmonary Efficiency and the Incidence of Gastrointestinal Disorders in Runners

NCT04530929 | Completed

• 1 other identifier: N/ST/MN/18/003/3316
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study was to assess the diet and the effect of probiotic therapy on reducing the incidence of gastrointestinal disorders and selected parameters determining the inflammation of the body, body composition, cardiopulmonary efficiency and selected serum biochemical parameters. 70 competitors took part in the study. The research was carried out at the Department of Dietetics and Clinical Nutrition (Medical University of Bialystok), Fitness Club Maniac Gym in Bialystok, as well as at the Hematological Diagnostics Department and the Biochemical Diagnostics Department of the University Teaching Hospital in Bialystok. The study was randomized using a double-blind trial. 35 persons selected in the draw were G1 group and the remaining G2 group (n=35). The intervention factor was the SANPROBI BARRIER multi-strain probiotic or placebo. Competitors used probiotic/ placebo for three months at a dose of 2x2 capsules daily (2.5 x 10 9 CFU / g (1 capsule)). The consent of the Bioethics Committee of the Medical University, no. RI-002/81/2017, was obtained for the study. The study consisted of two stages (W1 and W2), and each stage was associated with three visits by the participants. The first of these (W1) included qualification for the study, completing the questionnaire and 3-day nutrition diaries. At the second visit, body composition analysis and cardiopulmonary efficiency test on a medical treadmill were performed. For morphological tests (blood count with smear, lipid profile, fasting glucose, C-reactive protein and ionogram) at the third visit for each competitor was collected blood from the vein in the amount of 10 ml. The final stage (W2) included similar three visits, where the first visit was made after 3 months of taking product A or B. 66 competitors took part in it.

Conditions

Gastrointestinal Disorder, Functional

Keywords

probiotic; gastrointestinal disorder; long-distance running; body composition; cardiopulmonary efficiency

Outcome Measures

Primary Outcomes (5)

• Influence of probiotic Sanprobi Barrier on the occurrence of gastrointestinal disorders of long-distance runners.

  Subjective assessment (survey) of changes in the incidence and severity of gastrointestinal disorders in group of long-distance runners. Another survey at the beginning and end of the study.

  12 weeks (assessment at baseline and after 3 months of probiotic / placebo use)

• Influence of probiotic Sanprobi Barrier on the body composition of long-distance runners.

  Assessment of runner's body composition changes (body composition analysis used InBody 770 body composition analyzer). The following parameters were assessed: body weight (kg), body fat content in kilograms and percent, visceral fat content (cm2), skeletal muscle mass (kg), body water content (kg).

  12 weeks (assessment at baseline and after 3 months of probiotic / placebo use)

• Influence of probiotic Sanprobi Barrier on the cardiopulmonary efficiency of long-distance runners.

  Assessment of changes in cardiopulmonary efficiency of long-distance runners (testing the player's efficiency on a medical treadmill with the use of a sport tester and an oxygen mask. Bruce Test Protocol).

  12 weeks (assessment at baseline and after 3 months of probiotic / placebo use)

• Influence of probiotic Sanprobi Barrier on general inflammation of the body.

  Assessment of changes in parameters (C-reactive protein, TNF-alpha, IL-6) from blood.

  12 weeks (assessment at baseline and after 3 months of probiotic / placebo use)

• Influence of probiotic Sanprobi Barrier on blood biochemical parameters.

  Assessment of changes in parameters (complete blood count with smear, fasting glucose, total cholesterol, HDL, LDL and triglycerides, sodium, iron, potassium, magnesium, serum calcium) from blood.

  12 weeks (assessment at baseline and after 3 months of probiotic / placebo use)

Study Arms (2)

Group PROBIOTIC

ACTIVE COMPARATOR

The intervention factor was the SANPROBI BARRIER multi-strain probiotic (commonly available in pharmacies). Competitors used probiotic for three months at a dose of 2x2 capsules daily (2.5 x 109 CFU / g (1 capsule)).

Dietary Supplement: SANPROBI BARRIER

Group PLACEBO

PLACEBO COMPARATOR

Placebo created on the model of a probiotic capsule, specially for the needs of research, by Sanprobi Sp. z o.o.. Competitors used placebo for three months at a dose of 2x2 capsules daily.

Dietary Supplement: PLACEBO

Interventions

SANPROBI BARRIER DIETARY_SUPPLEMENT

Competitors used probiotic for three months at a dose of 2x2 capsules daily (2.5 x 109 CFU / g (1 capsule)).

Group PROBIOTIC

PLACEBO DIETARY_SUPPLEMENT

Competitors used placebo for three months at a dose of 2x2 capsules daily.

Group PLACEBO

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• women and men aged 20-60,
• running trainings over 5 km/day

You may not qualify if:

• use (other than in research) probiotics
• pacemaker

Sponsors & Collaborators

• Medical University of Bialystok: lead
• Maniac Gym Bialystok: collaborator
• University Teaching Hospital, Bialystok: collaborator

Study Sites (1)

Medical University of Bialystok

Bialystok, 15-089, Poland

Location

Related Publications (29)

• Videbaek S, Bueno AM, Nielsen RO, Rasmussen S. Incidence of Running-Related Injuries Per 1000 h of running in Different Types of Runners: A Systematic Review and Meta-Analysis. Sports Med. 2015 Jul;45(7):1017-26. doi: 10.1007/s40279-015-0333-8.

  PMID: 25951917 BACKGROUND

• Vitale K, Getzin A. Nutrition and Supplement Update for the Endurance Athlete: Review and Recommendations. Nutrients. 2019 Jun 7;11(6):1289. doi: 10.3390/nu11061289.

  PMID: 31181616 BACKGROUND

• Cox AJ, Pyne DB, Saunders PU, Fricker PA. Oral administration of the probiotic Lactobacillus fermentum VRI-003 and mucosal immunity in endurance athletes. Br J Sports Med. 2010 Mar;44(4):222-6. doi: 10.1136/bjsm.2007.044628. Epub 2008 Feb 13.

  PMID: 18272539 BACKGROUND

• Hill C, Guarner F, Reid G, Gibson GR, Merenstein DJ, Pot B, Morelli L, Canani RB, Flint HJ, Salminen S, Calder PC, Sanders ME. Expert consensus document. The International Scientific Association for Probiotics and Prebiotics consensus statement on the scope and appropriate use of the term probiotic. Nat Rev Gastroenterol Hepatol. 2014 Aug;11(8):506-14. doi: 10.1038/nrgastro.2014.66. Epub 2014 Jun 10.

  PMID: 24912386 BACKGROUND

• Huang WC, Lee MC, Lee CC, Ng KS, Hsu YJ, Tsai TY, Young SL, Lin JS, Huang CC. Effect of Lactobacillus plantarum TWK10 on Exercise Physiological Adaptation, Performance, and Body Composition in Healthy Humans. Nutrients. 2019 Nov 19;11(11):2836. doi: 10.3390/nu11112836.

  PMID: 31752370 BACKGROUND

• 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 BACKGROUND

• West NP, Pyne DB, Cripps AW, Hopkins WG, Eskesen DC, Jairath A, Christophersen CT, Conlon MA, Fricker PA. Lactobacillus fermentum (PCC(R)) supplementation and gastrointestinal and respiratory-tract illness symptoms: a randomised control trial in athletes. Nutr J. 2011 Apr 11;10:30. doi: 10.1186/1475-2891-10-30.

  PMID: 21477383 BACKGROUND

• Leite GSF, Resende Master Student AS, West NP, Lancha AH Jr. Probiotics and sports: A new magic bullet? Nutrition. 2019 Apr;60:152-160. doi: 10.1016/j.nut.2018.09.023. Epub 2018 Oct 22.

  PMID: 30590242 BACKGROUND

• Clark A, Mach N. Exercise-induced stress behavior, gut-microbiota-brain axis and diet: a systematic review for athletes. J Int Soc Sports Nutr. 2016 Nov 24;13:43. doi: 10.1186/s12970-016-0155-6. eCollection 2016.

  PMID: 27924137 BACKGROUND

• Holland AM, Hyatt HW, Smuder AJ, Sollanek KJ, Morton AB, Roberts MD, Kavazis AN. Influence of endurance exercise training on antioxidant enzymes, tight junction proteins, and inflammatory markers in the rat ileum. BMC Res Notes. 2015 Sep 30;8:514. doi: 10.1186/s13104-015-1500-6.

  PMID: 26423686 BACKGROUND

• Pugh JN, Sparks AS, Doran DA, Fleming SC, Langan-Evans C, Kirk B, Fearn R, Morton JP, Close GL. Four weeks of probiotic supplementation reduces GI symptoms during a marathon race. Eur J Appl Physiol. 2019 Jul;119(7):1491-1501. doi: 10.1007/s00421-019-04136-3. Epub 2019 Apr 13.

  PMID: 30982100 BACKGROUND

• Besselink MG, van Santvoort HC, Renooij W, de Smet MB, Boermeester MA, Fischer K, Timmerman HM, Ahmed Ali U, Cirkel GA, Bollen TL, van Ramshorst B, Schaapherder AF, Witteman BJ, Ploeg RJ, van Goor H, van Laarhoven CJ, Tan AC, Brink MA, van der Harst E, Wahab PJ, van Eijck CH, Dejong CH, van Erpecum KJ, Akkermans LM, Gooszen HG; Dutch Acute Pancreatitis Study Group. Intestinal barrier dysfunction in a randomized trial of a specific probiotic composition in acute pancreatitis. Ann Surg. 2009 Nov;250(5):712-9. doi: 10.1097/SLA.0b013e3181bce5bd.

  PMID: 19801929 BACKGROUND

• Schmitz L, Ferrari N, Schwiertz A, Rusch K, Woestmann U, Mahabir E, Graf C. Impact of endurance exercise and probiotic supplementation on the intestinal microbiota: a cross-over pilot study. Pilot Feasibility Stud. 2019 Jun 8;5:76. doi: 10.1186/s40814-019-0459-9. eCollection 2019.

  PMID: 31198580 BACKGROUND

• Clancy RL, Gleeson M, Cox A, Callister R, Dorrington M, D'Este C, Pang G, Pyne D, Fricker P, Henriksson A. Reversal in fatigued athletes of a defect in interferon gamma secretion after administration of Lactobacillus acidophilus. Br J Sports Med. 2006 Apr;40(4):351-4. doi: 10.1136/bjsm.2005.024364.

  PMID: 16556792 BACKGROUND

• West NP, Horn PL, Pyne DB, Gebski VJ, Lahtinen SJ, Fricker PA, Cripps AW. Probiotic supplementation for respiratory and gastrointestinal illness symptoms in healthy physically active individuals. Clin Nutr. 2014 Aug;33(4):581-7. doi: 10.1016/j.clnu.2013.10.002. Epub 2013 Oct 10.

  PMID: 24268677 BACKGROUND

• Strasser B, Geiger D, Schauer M, Gostner JM, Gatterer H, Burtscher M, Fuchs D. Probiotic Supplements Beneficially Affect Tryptophan-Kynurenine Metabolism and Reduce the Incidence of Upper Respiratory Tract Infections in Trained Athletes: A Randomized, Double-Blinded, Placebo-Controlled Trial. Nutrients. 2016 Nov 23;8(11):752. doi: 10.3390/nu8110752.

  PMID: 27886064 BACKGROUND

• Thomas DT, Erdman KA, Burke LM. Position of the Academy of Nutrition and Dietetics, Dietitians of Canada, and the American College of Sports Medicine: Nutrition and Athletic Performance. J Acad Nutr Diet. 2016 Mar;116(3):501-528. doi: 10.1016/j.jand.2015.12.006.

  PMID: 26920240 BACKGROUND

• Jang LG, Choi G, Kim SW, Kim BY, Lee S, Park H. The combination of sport and sport-specific diet is associated with characteristics of gut microbiota: an observational study. J Int Soc Sports Nutr. 2019 May 3;16(1):21. doi: 10.1186/s12970-019-0290-y.

  PMID: 31053143 BACKGROUND

• Cartee GD, Hepple RT, Bamman MM, Zierath JR. Exercise Promotes Healthy Aging of Skeletal Muscle. Cell Metab. 2016 Jun 14;23(6):1034-1047. doi: 10.1016/j.cmet.2016.05.007.

  PMID: 27304505 BACKGROUND

• Cheng J, Ouwehand AC. Gastroesophageal Reflux Disease and Probiotics: A Systematic Review. Nutrients. 2020 Jan 2;12(1):132. doi: 10.3390/nu12010132.

  PMID: 31906573 BACKGROUND

• Clarke SF, Murphy EF, O'Sullivan O, Lucey AJ, Humphreys M, Hogan A, Hayes P, O'Reilly M, Jeffery IB, Wood-Martin R, Kerins DM, Quigley E, Ross RP, O'Toole PW, Molloy MG, Falvey E, Shanahan F, Cotter PD. Exercise and associated dietary extremes impact on gut microbial diversity. Gut. 2014 Dec;63(12):1913-20. doi: 10.1136/gutjnl-2013-306541. Epub 2014 Jun 9.

  PMID: 25021423 BACKGROUND

• Lamprecht M, Bogner S, Schippinger G, Steinbauer K, Fankhauser F, Hallstroem S, Schuetz B, Greilberger JF. Probiotic supplementation affects markers of intestinal barrier, oxidation, and inflammation in trained men; a randomized, double-blinded, placebo-controlled trial. J Int Soc Sports Nutr. 2012 Sep 20;9(1):45. doi: 10.1186/1550-2783-9-45.

  PMID: 22992437 BACKGROUND

• Calero CDQ, Rincon EO, Marqueta PM. Probiotics, prebiotics and synbiotics: useful for athletes and active individuals? A systematic review. Benef Microbes. 2020 Mar 27;11(2):135-149. doi: 10.3920/BM2019.0076. Epub 2020 Feb 19.

  PMID: 32073297 BACKGROUND

• Shing CM, Peake JM, Lim CL, Briskey D, Walsh NP, Fortes MB, Ahuja KD, Vitetta L. Effects of probiotics supplementation on gastrointestinal permeability, inflammation and exercise performance in the heat. Eur J Appl Physiol. 2014 Jan;114(1):93-103. doi: 10.1007/s00421-013-2748-y. Epub 2013 Oct 23.

  PMID: 24150782 BACKGROUND

• Fedewa MV, Hathaway ED, Ward-Ritacco CL. Effect of exercise training on C reactive protein: a systematic review and meta-analysis of randomised and non-randomised controlled trials. Br J Sports Med. 2017 Apr;51(8):670-676. doi: 10.1136/bjsports-2016-095999. Epub 2016 Jul 21.

  PMID: 27445361 BACKGROUND

• Huang WC, Wei CC, Huang CC, Chen WL, Huang HY. The Beneficial Effects of Lactobacillus plantarum PS128 on High-Intensity, Exercise-Induced Oxidative Stress, Inflammation, and Performance in Triathletes. Nutrients. 2019 Feb 7;11(2):353. doi: 10.3390/nu11020353.

  PMID: 30736479 BACKGROUND

• Wosinska L, Cotter PD, O'Sullivan O, Guinane C. The Potential Impact of Probiotics on the Gut Microbiome of Athletes. Nutrients. 2019 Sep 21;11(10):2270. doi: 10.3390/nu11102270.

  PMID: 31546638 BACKGROUND

• Kim J, Yun JM, Kim MK, Kwon O, Cho B. Lactobacillus gasseri BNR17 Supplementation Reduces the Visceral Fat Accumulation and Waist Circumference in Obese Adults: A Randomized, Double-Blind, Placebo-Controlled Trial. J Med Food. 2018 May;21(5):454-461. doi: 10.1089/jmf.2017.3937. Epub 2018 Apr 24.

  PMID: 29688793 BACKGROUND

• Smarkusz-Zarzecka J, Ostrowska L, Leszczynska J, Cwalina U. Effect of a Multi-Strain Probiotic Supplement on Gastrointestinal Symptoms and Serum Biochemical Parameters of Long-Distance Runners: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Jul 30;19(15):9363. doi: 10.3390/ijerph19159363.

  PMID: 35954716 DERIVED

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Joanna Smarkusz-Zarzecka, PhD

  Department of Dietetics and Clinical Nutrition, Medical University of Bialystok

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 70 people meeting the inclusion criteria were included in the intervention and observational study. The study was randomized using a double-blind trial. 35 persons selected in the draw were G1 group and the remaining G2 group (n=35). The tests were completely anonymous, the competitors gave their informed written consent to carry them out. Interventional study was conducted using a probiotic or placebo. The intervention factor was the SANPROBI BARRIER multi-strain probiotic (commonly available in pharmacies) or placebo (created on the model of a probiotic capsule, specially for the needs of research, by Sanprobi Sp. z o.o.). Competitors used probiotic/ placebo for three months at a dose of 2x2 capsules daily (2.5 x 109 CFU / g (1 capsule)).

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 28, 2020
• Study Start: March 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: August 28, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)