Probiotic Supplementation and Endurance Performance in Cyclists and Masters Runners

NCT02756221 | Completed DMC

• 1 other identifier: Exercise Testing
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Viral Upper Respiratory Tract Infection; Gastroenteritis

Keywords

symptoms

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Probiotics

EXPERIMENTAL

Probiotics capsules, one capsule daily for 90 days.

Dietary Supplement: Probiotics

Placebo

PLACEBO COMPARATOR

Starch capsules, one capsule daily for 90 days

Other: Placebo

Interventions

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

Also known as: Taam Teva Digestion Caps

Probiotics

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel Hai College: lead

Study Sites (1)

Exercise Physiology Laboratory

Tel H̱ay, Israel

Location

Related Publications (3)

• 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.

  PMID: 25021423 RESULT

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

  PMID: 7556353 RESULT

• 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.

  PMID: 34001168 DERIVED

MeSH Terms

Conditions

Gastroenteritis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ron Golan, MD

  Ziv Medical Center, Zefat, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Exercise Physiology Laboratory

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 29, 2016
• Study Start: March 1, 2016
• Primary Completion: April 23, 2018
• Study Completion: April 23, 2018
• Last Updated: April 25, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will share

Locations

IL (1)