Efficacy of Probiotics on Physical Performance

March 19, 2019 updated by: Probi AB
Efficacy of probiotics on physical performance

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Umeå, Sweden, 90187
        • Idrottsmedicinska enheten, Umeå universitet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
Placebo
Active Comparator: Probiotic supplement
Dietary supplement: Probiotic supplement
Probiotic supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic response at standardized workloads during ergometer cycling
Time Frame: 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
4,8 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Probi AB

Investigators

  • Principal Investigator: Michael Svensson, PhD, Umeå University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2017

Primary Completion (Actual)

May 9, 2018

Study Completion (Actual)

May 9, 2018

Study Registration Dates

First Submitted

August 17, 2017

First Submitted That Met QC Criteria

August 21, 2017

First Posted (Actual)

August 24, 2017

Study Record Updates

Last Update Posted (Actual)

March 20, 2019

Last Update Submitted That Met QC Criteria

March 19, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • ProFormance135

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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