NCT03259997

Brief Summary

Efficacy of probiotics on physical performance

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 14, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2018

Completed
Last Updated

March 20, 2019

Status Verified

March 1, 2019

Enrollment Period

9 months

First QC Date

August 17, 2017

Last Update Submit

March 19, 2019

Conditions

Physical Performance

Outcome Measures

Primary Outcomes (1)

  • 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

    4,8 and 12 weeks

Study Arms (2)

Probiotic supplement

ACTIVE COMPARATOR
Dietary Supplement: Probiotic supplement

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Probiotic supplementDIETARY_SUPPLEMENT

Probiotic supplement

Probiotic supplement
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Idrottsmedicinska enheten, Umeå universitet

Umeå, 90187, Sweden

Location

Study Officials

  • Michael Svensson, PhD

    Umeå University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2017

First Posted

August 24, 2017

Study Start

August 14, 2017

Primary Completion

May 9, 2018

Study Completion

May 9, 2018

Last Updated

March 20, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)