Endurance TrainingULTRABCDNCT05424588
Physical and Cellular Effects of Ultra-cycling
An observational study of Endurance Training, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial summary
Background: NorthCape4000 (NC4000) is the most participated ultra-endurance cycling race. Eight healthy male Caucasian amateur cyclists were evaluated: a) before starting the preparation period; b) in the week preceding NC4000 (after the training period); c) after NC4000 race, with the aim to identify the effects of… Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Endurance Training
- What is being tested?
- clinical evaluation, bioelectrical impedance analysis (BIA), cardiopulmonary exercise testing (CPET) and venipuncture for blood samples collection
- How many people
- 8 participants
- Where
- 1 siteItaly
- Study dates
- 21 Dec 2020to 31 Dec 2021
- Phase
- Observational
- 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 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Eight healthy male amateur Caucasian cyclists (47,5±13,5 years) who attended the NC4000 4th edition.
Who may be able to join
- male amateur Caucasian cyclists who attended the NC4000 4th edition
Who cannot join
- any condition that might have altered performance or laboratory tests results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a 4400 km Ultra-cycling Non-competitive Race and Related Training on Body Composition and Circulating Progenitors Differentiation
Background: NorthCape4000 (NC4000) is the most participated ultra-endurance cycling race.
Eight healthy male Caucasian amateur cyclists were evaluated: a) before starting the preparation period; b) in the week preceding NC4000 (after the training period); c) after NC4000 race, with the aim to identify the effects of ultra-cycling on body composition, aerobic capacity and biochemical parameters as well as on the differentiation of progenitor cells.
Read more
Methods: Bioelectrical impedance analysis (BIA) and dual energy x-ray absorptiometry (DEXA) assessed body composition; cardiopulmonary exercise test (CPET) evaluated aerobic capacity. Differentiation of circulating progenitor cells was evaluated by analyzing the modulation in the expression of relevant transcription factors. In addition, in vitro experiments were performed to investigate the effects of sera of NC4000 participants on adipogenesis and myogenesis. The effects of NC4000 sera on Sestrins and Sirtuin modulation and the promotion of brown adipogenesis in progenitor cells was investigated as well. Two-tailed Student's paired-test was used to perform statistical analyses.
Results: We observed fat mass decrease after training as well as after NC4000 performance; we also recorded that vitamin D and lipid profiles were affected by ultra-cycling. In addition, our findings demonstrated that post-NC4000 participant's pooled sera exerted a positive effect in stimulating myogenesis and in inducing brown adipogenesis in progenitor cells.
Conclusions: The training program and Ultra-cycling lead to beneficial effects on body composition and biochemical lipid parameters, as well as changes in differentiation of progenitor cells , with significant increases in brown adipogenesis and in MYOD levels.
- Conditions
- Endurance Training
- Being tested
- clinical evaluation, bioelectrical impedance analysis (BIA), cardiopulmonary exercise testing (CPET) and venipuncture for blood samples collection
- Keywords
- ultra-cycling, training, body composition, cell differentiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical evaluation, bioelectrical impedance analysis (BIA), cardiopulmonary exercise testing (CPET) and venipuncture for blood samples collectionDiagnostic test
Total body dual-energy X-ray absorptiometry (DEXA) was taken BN and AN to measure total (FM) and segmental fat (truncal FM), visceral adipose tissue (VAT) and lean mass (LM). Tetra-polar dual frequency BIA (InBody 120; Cerritos, USA) was used BPP, BN and AN to measure weight and to estimate FM, FFM, and MM. Impedance measurements were performed. CPET was carried out on a cycle ergometer with clip-on pedals. Blood samples were collected in the morning BPP, BN, AN. Biochemical parameters considered in this study were: ALT, AST, creatinine, 25-hydroxy vitamin D, total cholesterol, HDL, LDL, triglycerides concentrations. We isolated CPCs from heparinized blood, as previously reported (14). After the collection of peripheral blood mononuclear cells (PBMCs) by a gradient centrifugation. (15). Differentiating Human Skeletal muscle cells were cultured with or without pooled sera of participants at 5% final concentration. 146b and 34a miRNAs were extracted from PBMCs.
| Study group | Role | What they receive |
|---|---|---|
| Healthy male amateur Caucasian cyclists | Healthy male amateur Caucasian cyclists who attended the NC4000 4th edition underwent clinical evaluation, bioelectrical impedance analysis (BIA), cardiopulmonary exercise testing (CPET) and venipuncture for blood samples collection. Receives: Diagnostic Test: clinical evaluation, bioelectrical impedance analysis (BIA), cardiopulmonary exercise testing (CPET) and venipuncture for blood samples collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
Total body dual-energy X-ray absorptiometry (DEXA) was taken BN and AN to measure total (FM) and segmental fat (truncal FM), visceral adipose tissue (VAT) and lean mass (LM)
Measured: DEC 2020-SEP 2021
Cell differentiation
possible association with commitment of circulating progenitors.
Measured: DEC 2020-SEP 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start21 Dec 2020
- Primary completion7 Sep 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endurance TrainingStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Michele Braggio, Dr.ssa Maria Teresa Valenti, Dr.ssa Arianna Minoia, Dr. Gianluigi Dorelli, Dr. Mattia Cominacini, Prof. Francesco Bertoldo, Dr.ssa Jessica Bertacco, Dr.ssa Tonia De Simone, Prof.ssa Maria Grazia Romanelli, Prof.ssa Monica Mottes, Dr.ssa Lekhana Bhandary
- Responsible party
- Principal investigator, Luca Giuseppe Dalle Carbonare, Azienda Ospedaliera Universitaria Integrata Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424588
- Sponsor's protocol ID
- ULTRANORD
- Acronym
- ULTRABCD
- Status last verified
- Jun 2022
- First submitted
- 15 Jun 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 4400 km Ultra-cycling Non-competitive Race and Related Training on Body Composition and Circulating Progenitors Differentiation
- ClinicalTrials.gov ID
- NCT05424588
- Acronym / sponsor ID
- ULTRABCD / ULTRANORD
- Conditions
- Endurance Training
- Keywords
- ultra-cycling, training, body composition, cell differentiation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Collaborators
- Dr. Michele Braggio, Dr.ssa Maria Teresa Valenti, Dr.ssa Arianna Minoia, Dr. Gianluigi Dorelli, Dr. Mattia Cominacini, Prof. Francesco Bertoldo, Dr.ssa Jessica Bertacco, Dr.ssa Tonia De Simone, Prof.ssa Maria Grazia Romanelli, Prof.ssa Monica Mottes, Dr.ssa Lekhana Bhandary
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 7 Sep 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 21 Jun 2022 (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.
Background: NorthCape4000 (NC4000) is the most participated ultra-endurance cycling race.
Eight healthy male Caucasian amateur cyclists were evaluated: a) before starting the preparation period; b) in the week preceding NC4000 (after the training period); c) after NC4000 race, with the aim to identify the effects of ultra-cycling on body composition, aerobic capacity and biochemical parameters as well as on the differentiation of progenitor cells.
Methods: Bioelectrical impedance analysis (BIA) and dual energy x-ray absorptiometry (DEXA) assessed body composition; cardiopulmonary exercise test (CPET) evaluated aerobic capacity. Differentiation of circulating progenitor cells was evaluated by analyzing the modulation in the expression of relevant transcription factors. In addition, in vitro experiments were performed to investigate the effects of sera of NC4000 participants on adipogenesis and myogenesis. The effects of NC4000 sera on Sestrins and Sirtuin modulation and the promotion of brown adipogenesis in progenitor cells was investigated as well. Two-tailed Student's paired-test was used to perform statistical analyses.
Results: We observed fat mass decrease after training as well as after NC4000 performance; we also recorded that vitamin D and lipid profiles were affected by ultra-cycling. In addition, our findings demonstrated that post-NC4000 participant's pooled sera exerted a positive effect in stimulating myogenesis and in inducing brown adipogenesis in progenitor cells.
Conclusions: The training program and Ultra-cycling lead to beneficial effects on body composition and biochemical lipid parameters, as well as changes in differentiation of progenitor cells , with significant increases in brown adipogenesis and in MYOD levels.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy male amateur Caucasian cyclists | – | Diagnostic Test: clinical evaluation, bioelectrical impedance analysis (BIA), cardiopulmonary exercise testing (CPET) and venipuncture for blood samples collectionHealthy male amateur Caucasian cyclists who attended the NC4000 4th edition underwent clinical evaluation, bioelectrical impedance analysis (BIA), cardiopulmonary exercise testing (CPET) and venipuncture for blood samples collection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Eight healthy male amateur Caucasian cyclists (47,5±13,5 years) who attended the NC4000 4th edition.
Key inclusion criteria (1 listed)
- male amateur Caucasian cyclists who attended the NC4000 4th edition
Key exclusion criteria (1 listed)
- any condition that might have altered performance or laboratory tests results
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 |
|---|---|---|
| clinical evaluation, bioelectrical impedance analysis (BIA), cardiopulmonary exercise testing (CPET) and venipuncture for blood samples collectionTotal body dual-energy X-ray absorptiometry (DEXA) was taken BN and AN to measure total (FM) and segmental fat (truncal FM), visceral adipose tissue (VAT) and lean mass (LM). Tetra-polar dual frequency BIA (InBody 120; Cerritos, USA) was used BPP, BN and AN to measure weight and to estimate FM, FFM, and MM. Impedance measurements were performed. CPET was carried out on a cycle ergometer with clip-on pedals. Blood samples were collected in the morning BPP, BN, AN. Biochemical parameters considered in this study were: ALT, AST, creatinine, 25-hydroxy vitamin D, total cholesterol, HDL, LDL, triglycerides concentrations. We isolated CPCs from heparinized blood, as previously reported (14). After the collection of peripheral blood mononuclear cells (PBMCs) by a gradient centrifugation. (15). Differentiating Human Skeletal muscle cells were cultured with or without pooled sera of participants at 5% final concentration. 146b and 34a miRNAs were extracted from PBMCs. | Diagnostic test | Healthy male amateur Caucasian cyclists |
Primary outcome
Body composition
Time frame: DEC 2020-SEP 2021
Total body dual-energy X-ray absorptiometry (DEXA) was taken BN and AN to measure total (FM) and segmental fat (truncal FM), visceral adipose tissue (VAT) and lean mass (LM)
Cell differentiation
Time frame: DEC 2020-SEP 2021
possible association with commitment of circulating progenitors.
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 21 Jun 2022.
- Individual participant dataSharing planned: No
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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?
An observational study of Endurance Training, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
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 1 inclusion and 1 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 21 Jun 2022. 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 Italy. 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?
Body composition (time frame: DEC 2020-SEP 2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2022.