Probiotic Supplementation and Endurance Performance in Cyclists and Masters Runners
Condition: Viral Upper Respiratory Tract Infection; Gastroenteritis
MeSH terms: Respiratory Tract Infections; Gastroenteritis
Study type: Interventional

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).
    

Intervention name(s): Probiotics; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 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; Placebo capsules identical in shape and color to the probiotics capsules, one capsule per day for 90 days
Other intervention name(s): Taam Teva Digestion Caps
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: symptoms