Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
8 participants
OBSERVATIONAL
2020-12-21
2021-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Eccentric Cycling Exercise on Mitochondrial Function of Lymphocyte
NCT06576804
The North Sea Race Endurance Exercise Study
NCT02166216
Eccentric Cycling Exercise With Assistive Devices on Mitochondrial Metabolism in T Lymphocyte
NCT06905964
Physiological Responses to a Prolonged Cycling Expedition in Older Men
NCT02353624
Myocene Sensivity to Cycling Intensities
NCT06913036
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
clinical evaluation, bioelectrical impedance analysis (BIA), cardiopulmonary exercise testing (CPET) and venipuncture for blood samples collection
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
clinical evaluation, bioelectrical impedance analysis (BIA), cardiopulmonary exercise testing (CPET) and venipuncture for blood samples collection
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
70 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dr. Michele Braggio
UNKNOWN
Dr.ssa Maria Teresa Valenti
UNKNOWN
Dr.ssa Arianna Minoia
UNKNOWN
Dr. Gianluigi Dorelli
UNKNOWN
Dr. Mattia Cominacini
UNKNOWN
Prof. Francesco Bertoldo
UNKNOWN
Dr.ssa Jessica Bertacco
UNKNOWN
Dr.ssa Tonia De Simone
UNKNOWN
Prof.ssa Maria Grazia Romanelli
UNKNOWN
Prof.ssa Monica Mottes
UNKNOWN
Dr.ssa Lekhana Bhandary
UNKNOWN
Azienda Ospedaliera Universitaria Integrata Verona
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Luca Giuseppe Dalle Carbonare
Associate Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
AOUI
Verona, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ULTRANORD
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.