NCT03747913

Brief Summary

It is already known from literature that exercise mobilizes stem and progenitor cells into the peripheral blood. However, the exact mechanisms thereof remain to be fully elucidated. The investigators hypothesize that exercise-induced oxidative stress could be at least one of the responsible mechanisms and therefore want to study the exercise-induced stem and progenitor cell mobilization in a group of healthy young men when they exercise with, compared to when they exercise without antioxidative supplementation. The primary outcome is numbers of stem and progenitor cells in the peripheral blood after an acute bout of exercise. As a secondary outcome, numbers of apoptotic mature and immature cells in the blood will be analysed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started May 2019

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

May 2, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2019

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

December 16, 2019

Status Verified

December 1, 2019

Enrollment Period

6 months

First QC Date

November 12, 2018

Last Update Submit

December 13, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in exercise-dependently mobilized stem and progenitor cell numbers in the peripheral blood with antioxidative supplementation

    Numbers of hematopoietic, endothelial and mesenchymal stem and progenitor cells and mature endothelial cells in the peripheral blood will be measured after an acute bout of exercise first without and then with prior antioxidative supplementation.

    On visit 2 after the exercise test without supplementation and then again on visit 3 after the exercise test with prior supplementation (1 week)

Secondary Outcomes (1)

  • Changes in numbers of exercise-induced apoptotic cells and oxidative stress markers in the peripheral blood with antioxidative supplementation

    On visit 2 after the exercise test without supplementation and then again on visit 3 after the exercise test with prior supplementation (1 week)

Study Arms (1)

Antioxidative Supplementation

EXPERIMENTAL

Each participant conducts two identical cycling tests, first without and a week later with antioxidative supplementation

Dietary Supplement: Antioxidative supplementation

Interventions

Each participant conducts two identical cycling tests, first without and a week later with antioxidative supplementation

Antioxidative Supplementation

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Non-smoking
  • Healthy
  • Normal Body-Mass-Index (BMI): 18.5-24.9 kg∙m-2
  • Active (fulfill World Health Organization-guidelines for recommended levels of physical activity for adults aged 18 - 64 years)
  • Willing to adhere to the study rules

You may not qualify if:

  • Known or suspected non-compliance, drug or alcohol abuse
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders etc. of the participant
  • Previous enrolment into the current study
  • Enrolment of the investigator, his/her family members, employees and other dependent persons
  • Regular intake of medication
  • Regular intake of antioxidant supplementations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich

Zurich, Canton of Zurich, 8057, Switzerland

Location

Related Publications (1)

  • Schmid M, Martins HC, Schratt G, Kropfl JM, Spengler CM. MiRNA126 - RGS16 - CXCL12 Cascade as a Potential Mechanism of Acute Exercise-Induced Precursor Cell Mobilization. Front Physiol. 2021 Dec 9;12:780666. doi: 10.3389/fphys.2021.780666. eCollection 2021.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Each participant enrolled in the study will be part of the supplementation and control condition group in a non-randomized order
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2018

First Posted

November 20, 2018

Study Start

May 2, 2019

Primary Completion

October 21, 2019

Study Completion

October 31, 2019

Last Updated

December 16, 2019

Record last verified: 2019-12

Locations