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OpenTrials
Completed

NCT Number: NCT05424588

Physical and Cellular Effects of Ultra-cycling

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

Male

Study type

Observational

Primary location

AOUI

Verona, 37134, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Diagnostic 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.

Primary outcomes

  1. 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)

  2. Cell differentiation

    Time frame: DEC 2020-SEP 2021

    possible association with commitment of circulating progenitors.

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Other

Collaborators

  • Dr. Gianluigi Dorelli
  • Dr. Mattia Cominacini
  • Dr. Michele Braggio
  • Dr.ssa Arianna Minoia
  • Dr.ssa Jessica Bertacco
  • Dr.ssa Lekhana Bhandary
  • Dr.ssa Maria Teresa Valenti
  • Dr.ssa Tonia De Simone
  • Prof. Francesco Bertoldo
  • Prof.ssa Maria Grazia Romanelli
  • Prof.ssa Monica Mottes

Registry information

Official study title

Effects of a 4400 km Ultra-cycling Non-competitive Race and Related Training on Body Composition and Circulating Progenitors Differentiation

Acronym: ULTRABCD

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 21, 2022
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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