CompletedNCT03259997Updated Mar 20, 2019

Efficacy of Probiotics on Physical Performance

An interventional study of Probiotic supplement and Placebo in Physical Performance, sponsored by Probi AB. Completed at 1 site in Sweden. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-20.

Sponsored by Probi AB · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 53
Allocation: Randomized
Ages: 18 Years to 40 Years
Sex: All

Study summary

Efficacy of probiotics on physical performance

Conditions studied

Physical Performance

Who can participate

Ages eligible: 18 Years to 40 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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)

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 53 participants (actual)

Study arms

Active comparator
Probiotic supplement
Dietary Supplement: Probiotic supplement
Placebo comparator
Placebo
Dietary Supplement: Placebo

Interventions

Dietary supplementProbiotic supplement
Probiotic supplement
Dietary supplementPlacebo
Placebo

What researchers measure

Primary outcomes

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

Study locations

1 site

Idrottsmedicinska enheten, Umeå universitet
Umeå, 90187, Sweden

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT03259997
Lead sponsor: Probi AB
Responsible party: Sponsor
First posted: Aug 24, 2017
Start date: Aug 14, 2017
Primary completion: May 9, 2018
Completion: May 9, 2018
Last update: Mar 20, 2019

Study contacts

Michael Svensson, PhD

principal investigator · Umeå University

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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