Gastrointestinal Microbiome Clinical Trial
— KOMSOfficial title:
Sauerkraut Supplementation in Athletes for Gut Microbiome Optimization: Case Series and Literature Review (Project KOMS)
Verified date | November 2023 |
Source | The Gut Microbiome Center (Centar za crijevni mikrobiom) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | November 29, 2023 |
Est. primary completion date | November 13, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - regularly engaging in professional sports activities 1. categorized athlete by HOO 2. playing sports as a source of income (bodybuilding) - older than 18 years old - general general state of health - written understanding of the English language Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Croatia | Gut Microbiome Center | Zagreb |
Lead Sponsor | Collaborator |
---|---|
The Gut Microbiome Center (Centar za crijevni mikrobiom) | University of Zagreb |
Croatia,
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: 10.1 — View Citation
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. — View Citation
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. — View Citation
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, Te — View Citation
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- — View Citation
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 Nut — View Citation
Nichols AW. Probiotics and athletic performance: a systematic review. Curr Sports Med Rep. 2007 Jul;6(4):269-73. — View Citation
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 At — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Future | -long term gut microbiota change-
After two months from the last stool sample,the respondents takes again a stool sample from the subject, and the analysis of the intestinal microbiota is performed again as described in the previous section. -comparison with similar study- During data processing, the results of this research will be compared with the results of the previous research, which is different from this one research used prebiotics and not synbiotics in the intervention. Previous research registered in the ClinicalTrials.gov registry under no NCT05726435 was designed as a randomized placebo-controlled intervention study. The respondents, professional athletes, were during the 4 weeks, one group received either prebiotics, NUTRIOSE fibers, or a placebo in the amount of 20g divided into two doses of 10g each. |
three months |
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