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Viral Upper Respiratory Tract InfectionNCT02756221

Probiotic Supplementation and Endurance Performance in Cyclists and Masters Runners

A study testing Probiotics in people with Viral Upper Respiratory Tract Infection and Gastroenteritis, run by Tel Hai College at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years, men onlyHealthy volunteers can take part
What is being tested?
Probiotics
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 participants
Where
1 siteIsrael
Study dates
Mar 2016to 23 Apr 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Exercise Physiology Laboratory

    Tel H̱ay

Other trials in Israel

About this study

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

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.

Read the 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).

Being tested
Probiotics, Placebo
Keywords
symptoms
Medical subject headings
Gastroenteritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ProbioticsDietary supplement

    Also called Taam Teva Digestion Caps

    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

  • PlaceboOther

    Placebo capsules identical in shape and color to the probiotics capsules, one capsule per day for 90 days

Study groups in NCT02756221
Study groupRoleWhat they receive
ProbioticsExperimentalProbiotics capsules, one capsule daily for 90 days.
Receives: Dietary Supplement: Probiotics
PlaceboPlacebo comparatorStarch capsules, one capsule daily for 90 days
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximal oxygen consumption (VO2max)

    Maximal oxygen consumption (VO2max, l/min, or ml/min/kg) is expected to rise following 2 months of supplementation

    Measured: 90 days

  2. 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)

    Measured: 90 days

  3. 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

    Measured: 90 days

  4. 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

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2016 (estimated)
  2. Study startMar 2016
  3. Primary completion23 Apr 2018
  4. Study completion23 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02756221
Sponsor's protocol ID
Exercise Testing
Status last verified
Apr 2018
First submitted
11 Apr 2016
Last updated
25 Apr 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Anonymous individual subjects data for all outcome measures will be made available within 12 months of study completion

Publications

  • 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.

    PubMed 25021423

  • Coyle EF. Integration of the physiological factors determining endurance performance ability. Exerc Sport Sci Rev. 1995;23:25-63.

    PubMed 7556353

  • 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.

    PubMed 34001168

Questions about this trial

What is this clinical trial studying?

A study testing Probiotics in people with Viral Upper Respiratory Tract Infection and Gastroenteritis, run by Tel Hai College at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal oxygen consumption (VO2max) (time frame: 90 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02756221, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2018.

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