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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tel Hai College
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Maximal oxygen consumption (VO2max)
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Placebo
Starch capsules, one capsule daily for 90 days
Intervention: Placebo (Other)
Probiotics
Probiotics capsules, one capsule daily for 90 days.
Intervention: Probiotics (Dietary Supplement)
Outcomes
Primary Outcomes
Maximal oxygen consumption (VO2max)
Time Frame: 90 days
Maximal oxygen consumption (VO2max, l/min, or ml/min/kg) is expected to rise following 2 months of supplementation
Ventilatory threshold (VTH)
Time Frame: 90 days
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)
Running economy
Time Frame: 90 days
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
Time to Fatigue
Time Frame: 90 days
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Itzik Weinstein
Head Exercise Physiology Laboratory
Tel Hai College