Probiotic Supplementation and Endurance Performance in Cyclists and Masters Runners

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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: A series of preliminary tests (Anthropometry, Maximal Oxygen Consumption, Endurance tests) will be conducted by one of the study physicians from Ziv Medical Center in Zefat Food Frequency Questionnaires (FFQ ) and frequency of GI symptoms will be completed electronically with Qualtrics (Qualtrics LLC, Provo, UT, USA) Blood samples (approximately 10 ml of venous blood) for quantifying immune factors (inflammation) will be collected at Ziv Medical Center or at Tel Hai Academic College and will be sent to the molecular microbiology and biotechnology laboratory in Tel Aviv University. Stool samples for testing the genetic expression of the microbiome composition. The tests will be delivered to the study staff at Tel Hai University and after freezing them, they will be sent together in dry ice to the molecular microbiology and biotechnology laboratory in Tel Aviv University Tests for evaluating aerobic endurance (Lactate Threshold - cyclists, running economy or time to fatigue - runners) will be conducted at the exercise physiology laboratory in Tel Hai College. 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).

Official Title
-----------------
The Effect of Probiotic Supplementation on the Incidence of Gastrointestinal (GI) Tract and Upper Respiratory System Symptoms and the Endurance Exercise Performance in Masters Runners and Elite Cyclists

Conditions
-----------------
Gastroenteritis, Viral Upper Respiratory Tract Infection

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotics
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-60 years at least 3 years of national-level experience, including participation in competitions suffer from one or more of the following symptoms: nausea, vomiting, belching, heartburn and chest pain, bloating, cramps, side pain, urge to empty bowels and diarrhea during training and competitions Exclusion Criteria: Diagnosis of gastrointestinal diseases Diagnosis of heart diseases Use of Probiotics during the 3 months' period prior to the study Use of Antibiotics during the 3 months' period prior to the study A radical surgery in the digestive system during the year prior to the

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics<br>Probiotics capsules, one capsule daily for 90 days. | Dietary Supplement: Probiotics<br>* 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<br>* Other names: Taam Teva Digestion Caps;|
| Placebo Comparator: Placebo<br>Starch capsules, one capsule daily for 90 days | Other: Placebo<br>* Placebo capsules identical in shape and color to the probiotics capsules, one capsule per day for 90 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
symptoms