Efficacy of Probiotics on Physical Performance

NCT03259997 — Not applicable, Completed, 53 participants, Probi AB

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT03259997
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, prevention
Enrollment	53 (Actual)
Sponsor	Probi AB (Industry)
Conditions	Physical Performance
Interventions	Probiotic supplement, Placebo (Dietary supplement)
Dates	start 2017-08-14, primary completion 2018-05-09, completion 2018-05-09, first posted 2017-08-24, last updated 2019-03-20
Locations	1 site in Sweden

-Summary

Efficacy of probiotics on physical performance

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+Arms and interventions

Arm	Type	Interventions	Description
Probiotic supplement	Active comparator	Dietary Supplement: Probiotic supplement
Placebo	Placebo comparator	Dietary Supplement: Placebo

Probiotic supplement (Dietary supplement): Probiotic supplement
Placebo (Dietary supplement): Placebo

+Outcome measures

Primary outcomes

Metabolic response at standardized workloads during ergometer cycling [4,8 and 12 weeks]: Change from baseline in metabolic response at standardized workloads during ergometer cycling after 4,8 and 12 weeks of supplementation

+Eligibility

Sex: All, ages: 18 Years to 40 Years, accepts healthy volunteers

Inclusion Criteria:

* Male or female, aged 18 to 40 years, at the time of signing the informed consent form
* Provides signed and dated informed consent form
* Engaged in competitive sports and regularly training
* Non-anemic, iron-deficient
* Willing to comply with all study procedures and be available for the duration of the study

Exclusion Criteria:

* Use of probiotics
* Use of iron supplementation
* Use of ascorbic acid (Vitamin C) supplementation
* Hypersensitivity to any of the ingredients in the investigational product (IP)

+Locations (1)

Facility	City	Country	Status
Idrottsmedicinska enheten, Umeå universitet	Umeå	Sweden

+Investigators

Michael Svensson, PhD, Principal investigator, Umeå University