NCT05424588

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2020

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

Study Start

First participant enrolled

December 21, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

9 months

First QC Date

June 15, 2022

Last Update Submit

June 15, 2022

Conditions

Keywords

ultra-cyclingtrainingbody compositioncell differentiation

Outcome Measures

Primary Outcomes (2)

  • 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)

    DEC 2020-SEP 2021

  • Cell differentiation

    possible association with commitment of circulating progenitors.

    DEC 2020-SEP 2021

Study Arms (1)

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.

Diagnostic Test: clinical evaluation, bioelectrical impedance analysis (BIA), cardiopulmonary exercise testing (CPET) and venipuncture for blood samples collection

Interventions

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.

Healthy male amateur Caucasian cyclists

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Eight healthy male amateur Caucasian cyclists (47,5±13,5 years) who attended the NC4000 4th edition.

You may qualify if:

  • male amateur Caucasian cyclists who attended the NC4000 4th edition

You may not qualify if:

  • any condition that might have altered performance or laboratory tests results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOUI

Verona, 37134, Italy

Location

MeSH Terms

Interventions

Physical ExaminationExercise TestPhlebotomy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHeart Function TestsDiagnostic Techniques, CardiovascularRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative TechniquesBlood Specimen CollectionSpecimen HandlingClinical Laboratory TechniquesPuncturesTherapeuticsSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 15, 2022

First Posted

June 21, 2022

Study Start

December 21, 2020

Primary Completion

September 7, 2021

Study Completion

December 31, 2021

Last Updated

June 21, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations