HealthyEISMONCT03747913
Oxidative Stress as an Acute Exercise-induced Mechanism of Stem and Progenitor Cell Mobilization
A study testing Antioxidative supplementation in people with Healthy, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Antioxidative supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 May 2019to 31 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich
Zurich, Canton of Zurich, 8057
About this study
Official title: Effect of Oxidative Stress on Acute Exercise-induced Mobilization and Apoptosis of Hematopoietic, Endothelial and Mesenchymal Stem and Progenitor Cells and Mature Endothelial Cells in Healthy Young Male Subjects
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.
- Conditions
- Healthy
- Being tested
- Antioxidative supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antioxidative supplementationDietary supplement
Each participant conducts two identical cycling tests, first without and a week later with antioxidative supplementation
| Study group | Role | What they receive |
|---|---|---|
| Antioxidative Supplementation | Experimental | Each participant conducts two identical cycling tests, first without and a week later with antioxidative supplementation Receives: Dietary Supplement: Antioxidative supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Numbers of apoptotic mononuclear cells, apoptotic hematopoietic, endothelial and mesenchymal stem and progenitor cells and apoptotic mature endothelial cells, as well as in oxidative stress markers in the peripheral blood will be measured after an acute bout of exercise first without and then with prior antioxidative supplementation.
Measured: On visit 2 after the exercise test without supplementation and then again on visit 3 after the exercise test with prior supplementation (1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start2 May 2019
- Primary completion21 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant enrolled in the study will be part of the supplementation and control condition group in a non-randomized order
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747913
- Sponsor's protocol ID
- EISMO
- Acronym
- EISMO
- Status last verified
- Dec 2019
- First submitted
- 12 Nov 2018
- Last updated
- 16 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34955891
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oxidative Stress on Acute Exercise-induced Mobilization and Apoptosis of Hematopoietic, Endothelial and Mesenchymal Stem and Progenitor Cells and Mature Endothelial Cells in Healthy Young Male Subjects
- ClinicalTrials.gov ID
- NCT03747913
- Acronym / sponsor ID
- EISMO / EISMO
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- 2 May 2019 (actual)
- Primary completion
- 21 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 20 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant enrolled in the study will be part of the supplementation and control condition group in a non-randomized order
| Arm | Type | Receives |
|---|---|---|
| Antioxidative Supplementation | Experimental | Dietary Supplement: Antioxidative supplementationEach participant conducts two identical cycling tests, first without and a week later with antioxidative supplementation |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antioxidative supplementationEach participant conducts two identical cycling tests, first without and a week later with antioxidative supplementation | Dietary supplement | Antioxidative Supplementation |
Primary outcome
Changes in exercise-dependently mobilized stem and progenitor cell numbers in the peripheral blood with antioxidative supplementation
Time frame: On visit 2 after the exercise test without supplementation and then again on visit 3 after the exercise test with prior supplementation (1 week)
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.
1 secondary outcome
Changes in numbers of exercise-induced apoptotic cells and oxidative stress markers in the peripheral blood with antioxidative supplementation
Time frame: On visit 2 after the exercise test without supplementation and then again on visit 3 after the exercise test with prior supplementation (1 week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Derived from this study: PubMed 34955891Schmid 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antioxidative supplementation in people with Healthy, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in exercise-dependently mobilized stem and progenitor cell numbers in the peripheral blood with antioxidative supplementation (time frame: On visit 2 after the exercise test without supplementation and then again on visit 3 after the exercise test with prior supplementation (1 week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03747913, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019.