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The study will evaluate the change in gastrointestinal (GI) flora following probiotic supplementation, and expected to lead to an increase in the intestinal epithelial integrity and to improvement in its health. Concurrently with the reduction in the amount of toxins in the GI tract following an intensive exercise, a lower incidence of symptoms of discomfort will improve the quality of the training sessions which will be exhibited by an improvement in endurance capacity and in physiological responses to rigorous exercise. Half of the participants will receive probiotic supplement while the other half will receive a placebo.
Masters runners and professional competitive cyclists will be recruited, as follows: 30 young road cyclists ages 18-39 years, 60 masters runners ages 40-60 years
Sample Size: 90 subjects will be recruited, following the first set of tests and experiments will randomly be divided into two matched groups experimental and experimental groups. The rational for sample size calculation is based on detecting a defined effect size with 5% statistical significance and 80% power. Effect size reflects the difference in the treatment effect between the groups will be calculated as the difference in measurement values between the experimental (probiotics) and control (placebo) groups divided by the standard deviation. Cyclists' cohort will include 34 subjects which will demonstrate effect size of 1.0. Masters runners' cohort will include 60 subjects which will demonstrate effect size of 0.75.
Study design: A random double-blind prospective study
Recruitment of participants will be executed by study staff which will also serve as trainers of cycling and running groups in Israel's Upper Galilee area.
Subsequently to signing on an informed consent form with one of the study physicians, participants will complete the following procedures:
After the completion of tests, participants will randomly be divided to 2 matched groups according to the level of physical fitness, and age in a double-blind design. The experimental (E) group will be given probiotic supplement in capsule form whereas the control (C) group will be given placebo capsules identical in size and color to the probiotic ones.
The participants will consume the supplement / placebo capsules during a period of 90 days after which they will return for an additional visit in which they will re-complete questionnaires and will undergo identical tests and procedures which they had completed during their first visit (before the assignment into groups).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics | Experimental | Probiotics capsules, one capsule daily for 90 days. |
|
| Placebo | Placebo Comparator | Starch capsules, one capsule daily for 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics | Dietary Supplement | One capsule per day for 90 days. Containing 8 x 109 CFU of bacteria /capsule Lactobacillus heleveticus Lafti L10 Bifidobacterium animalis ssp lactis Lafti B94 Enterococcus faecium Rosell-26 Bifidobacterium longum RO175 Bacillus subtills Rosell-179 Inactive ingredients: potato starch, magnesium stearate, ascorbic acid White vegetable capsule size 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal oxygen consumption (VO2max) | Maximal oxygen consumption (VO2max, l/min, or ml/min/kg) is expected to rise following 2 months of supplementation | 90 days |
| Ventilatory threshold (VTH) | Ventilatory threshold (VTH), determined during a graded exercise test which measures maximal oxygen consumption (VO2max), and is the deflection point of CO2 production vs VO2 and is expressed as the running speed (km/h) at which it is occurs, and also as percentage of VO2max. Following 3 months of supplementation a right shift in the VTH curve is expected indicating an improved aerobic endurance, meaning that it is occurring at a higher running velocity (km/h) | 90 days |
| Running economy | Running economy calculated from the slope of oxygen consumption (VO2) vs 3-4 submaximal running velocities (km/h) is expected to improve, the lower the slope (Liter Oxygen/km/hour) the better the running economy | 90 days |
| Time to Fatigue | Time to fatigue (minute; seconds) calculated as at exercise intensity of 85-88% of VO2max is expected to rise, increased time to fatigue indicates improved aerobic endurance | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ron Golan, MD | Ziv Medical Center, Zefat, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Exercise Physiology Laboratory | Tel H̱ay | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25021423 | Result | 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. | |
| 7556353 |
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Anonymous individual subjects data for all outcome measures will be made available within 12 months of study completion
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| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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|
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| Placebo | Other | Placebo capsules identical in shape and color to the probiotics capsules, one capsule per day for 90 days |
|
| Coyle EF. Integration of the physiological factors determining endurance performance ability. Exerc Sport Sci Rev. 1995;23:25-63. |
| 34001168 | Derived | Schreiber C, Tamir S, Golan R, Weinstein A, Weinstein Y. The effect of probiotic supplementation on performance, inflammatory markers and gastro-intestinal symptoms in elite road cyclists. J Int Soc Sports Nutr. 2021 May 17;18(1):36. doi: 10.1186/s12970-021-00432-6. |
| D019602 |
| Food and Beverages |