Physical and Cellular Effects of Ultra-cycling (ULTRABCD)

June 15, 2022 updated by: Luca Giuseppe Dalle Carbonare, Azienda Ospedaliera Universitaria Integrata Verona

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.

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 Overview

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Verona, Italy, 37134
        • AOUI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
DEC 2020-SEP 2021
Cell differentiation
Time Frame: DEC 2020-SEP 2021
possible association with commitment of circulating progenitors.
DEC 2020-SEP 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2020

Primary Completion (Actual)

September 7, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

June 15, 2022

First Submitted That Met QC Criteria

June 15, 2022

First Posted (Actual)

June 21, 2022

Study Record Updates

Last Update Posted (Actual)

June 21, 2022

Last Update Submitted That Met QC Criteria

June 15, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • ULTRANORD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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