NCT06087146

Brief Summary

Literature on the topic of athlete gut microbiota is scarce, and even more on the topic of its modulation. To address these issues a prospective cohort study was conceived. The cohort included young, male generally healthy professional athletes. The cohort will first be exposed to a course of sauerkraut supplementation as a synbiotic. Then the cohort will be observed without any intention for gut microbiota modulation. Before and after each study phase a gut microbiota analysis will be performed for its parameters. The aim of this study is to assess whether the intervention leads to significant changes in the gut microbiota parameters in all subjects and if yes what the signal of the intervention was, meaning whether the changes were consistent among all subjects regarding the analyzed parameter and its direction of effect. The results will be compared with data from earlier research on gut microbiota modulation in professional athletes with soluble fiber as prebiotics and a placebo. The study will provide valuable data on the athlete gut microbiota and its potential modulation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

October 31, 2023

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2023

Completed
Last Updated

December 5, 2023

Status Verified

November 1, 2023

Enrollment Period

13 days

First QC Date

October 11, 2023

Last Update Submit

November 29, 2023

Conditions

Keywords

MicrobiotaSportsAthletesNutrition SurveysProbiotics

Outcome Measures

Primary Outcomes (1)

  • Current

    -short term gut microbiota change- The impact of sauerkraut on gut microbiome shall assessed through monitoring of relative taxonomic abundance of bacteria that compose gut microbiota from samples taken day before the intervention and immediately after the intervention. The composition of the intestinal microbiota will be determined by sequencing the 16s rRNA bacteria in the stool sample. Subjects take a sample with a sterile cotton swab by wiping stool with toilet paper in their home on a given day research. The sample is stored in a tube with a buffer liquid so that the sample can be stored and transported at room temperature temperature. The test sample is transported by air to the laboratory of Biomes NGS Gesellschaft mit beschränkter Haftung, Wildau, Germany. The laboratory performs independently

    one month

Secondary Outcomes (1)

  • Future

    three months

Study Arms (1)

Athletes supplemented with sauerkraut

EXPERIMENTAL

10 professional athletes (9 male) who will during 10 days consume approximately 250 g of sauerkraut (Brassica oleracea v. capitata) daily.

Other: Sauerkraut (Brassica oleracea v. capitata)

Interventions

The research material is a donation from the company Eko Bio Zrnje, Vrbovec, Croatia. It's grated pickle cabbage produced by fermentation in a saline solution (NaCl) in which the fermentation was stopped by pasteurization and was packed in glass 500g jars. The nutritional and microbiological composition was tested by the laboratories of the Faculty of Food and Biotechnology, as well as by the cultural laboratory approach confirmed the presence of bacteria that produce lactic acid (4.82·103 (±2.31) CFU/mL)

Athletes supplemented with sauerkraut

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • regularly engaging in professional sports activities
  • categorized athlete by HOO
  • playing sports as a source of income (bodybuilding)
  • older than 18 years old
  • general general state of health
  • written understanding of the English language

You may not qualify if:

  • use of antibiotics for a period of at least six months before participating in the study application of nutritional supplements with the potential to modulate intestinal microbiota (probiotics, prebiotics, postbiotics) in the period from
  • at least six months before participating in the study
  • chronic drug therapy
  • intolerance of one of the interventions (sauerkraut, fasting, probiotics and their additives)
  • chronic medical therapy (except for vitamins, thyroid hormones and antihistamines)
  • kidney function disorder
  • liver function disorder
  • history of digestive problems at the time before the study (diarrhea, dyspepsia, constipation)
  • hormonal disorder (except hypothyroidism)
  • psychological or mental disorder
  • involvement in other research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gut Microbiome Center

Zagreb, 10000, Croatia

Location

Related Publications (9)

  • Nichols AW. Probiotics and athletic performance: a systematic review. Curr Sports Med Rep. 2007 Jul;6(4):269-73.

  • 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.

  • Toohey JC, Townsend JR, Johnson SB, Toy AM, Vantrease WC, Bender D, Crimi CC, Stowers KL, Ruiz MD, VanDusseldorp TA, Feito Y, Mangine GT. Effects of Probiotic (Bacillus subtilis) Supplementation During Offseason Resistance Training in Female Division I Athletes. J Strength Cond Res. 2020 Nov;34(11):3173-3181. doi: 10.1519/JSC.0000000000002675.

  • Mohr AE, Pugh J, O'Sullivan O, Black K, Townsend JR, Pyne DB, Wardenaar FC, West NP, Whisner CM, McFarland LV. Best Practices for Probiotic Research in Athletic and Physically Active Populations: Guidance for Future Randomized Controlled Trials. Front Nutr. 2022 Mar 8;9:809983. doi: 10.3389/fnut.2022.809983. eCollection 2022.

  • Marco ML, Hutkins R, Hill C, Fulgoni VL, Cifelli CJ, Gahche J, Slavin JL, Merenstein D, Tancredi DJ, Sanders ME. A Classification System for Defining and Estimating Dietary Intake of Live Microbes in US Adults and Children. J Nutr. 2022 Jul 6;152(7):1729-1736. doi: 10.1093/jn/nxac074.

  • Dimidi E, Cox SR, Rossi M, Whelan K. Fermented Foods: Definitions and Characteristics, Impact on the Gut Microbiota and Effects on Gastrointestinal Health and Disease. Nutrients. 2019 Aug 5;11(8):1806. doi: 10.3390/nu11081806.

  • Touret T, Oliveira M, Semedo-Lemsaddek T. Putative probiotic lactic acid bacteria isolated from sauerkraut fermentations. PLoS One. 2018 Sep 7;13(9):e0203501. doi: 10.1371/journal.pone.0203501. eCollection 2018.

  • Costa MS, Toscano LT, Toscano LLT, Luna VR, Torres RA, Silva JA, Silva AS. Ergogenic potential of foods for performance and recovery: a new alternative in sports supplementation? A systematic review. Crit Rev Food Sci Nutr. 2022;62(6):1480-1501. doi: 10.1080/10408398.2020.1844137. Epub 2020 Nov 23.

  • Hughes RL, Holscher HD. Fueling Gut Microbes: A Review of the Interaction between Diet, Exercise, and the Gut Microbiota in Athletes. Adv Nutr. 2021 Dec 1;12(6):2190-2215. doi: 10.1093/advances/nmab077.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2023

First Posted

October 17, 2023

Study Start

October 31, 2023

Primary Completion

November 13, 2023

Study Completion

November 29, 2023

Last Updated

December 5, 2023

Record last verified: 2023-11

Locations