search
Back to results

The Influence of Endurance Sports Activity on the Oral Microbiota of Young Adults. (ORAMICAP)

Primary Purpose

Microbial Colonization

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
salivar and gum sampling
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Microbial Colonization

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Be between 18 and 30 years old If practicing sports, it must be an endurance sport as main activity (cycling or running) Exclusion Criteria: Practice more than 3 hours of swimming per week Have taken anti-inflammatory drugs, less than 48 hours before the study Have taken antibiotics and/or probiotics, less than 3 weeks before the study

Sites / Locations

  • Nice University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

sedentary

OMS recommandations

More than the OMS recommandations

Arm Description

Participant does not meet WHO's recommendations with the physical activity

Participant does not meet WHO's recommendations (2.5-5 hours per week of moderate physical activity OR 1.25-2.5 hours per week of vigorous physical activity);

Participant is practicing physical activity more than the WHO recommendations

Outcomes

Primary Outcome Measures

Analysis of the oral microbiota in healthy individuals engaged in endurance physical activity at different levels.
Microbiological screening will be performed using an innovative methodology based on microfluidic PCR (BiomarkHD) (number of bacterial colonies)

Secondary Outcome Measures

Quantification of salivary inflammatory markers in healthy individuals who perform endurance physical activity at different levels.
numer and type of salivary inflammatory markers will performed using multiplex analysis technology developed by the firm Meso Scale Diagnostic (MSD).

Full Information

First Posted
March 1, 2023
Last Updated
March 1, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
search

1. Study Identification

Unique Protocol Identification Number
NCT05765422
Brief Title
The Influence of Endurance Sports Activity on the Oral Microbiota of Young Adults.
Acronym
ORAMICAP
Official Title
Sport and Health a Pilot Study: Impact of Endurance Physical Activity on the Microbiological Homeostasis of the Oral Cavity of Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 15, 2023 (Anticipated)
Primary Completion Date
March 15, 2026 (Anticipated)
Study Completion Date
March 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The oral cavity is an easily accessible anatomical site that accurately reflects the health of the individual. The mouth is considered an early indicator of biological aging, leading to the identification of oral biomarkers predictive of future alterations. Current data show that the oral health of high level athletes is globally altered with an increase in cariogenic indexes, an increased incidence of periodontitis, dental trauma and dry mouth syndromes. Few studies have focused on the oral microbiota compared to mouthguards used in rugby or boxing which seem to induce dysbiosis, a recent study shows an effect of ketogenic diet on bacterial changes in the mouth of endurance athletes. This project focuses on the impact of intensive sport practice on oral health and the identification of oral biomarkers associated with physical activity. The objective of this study is to investigate the impact of the amount of endurance sport practice on oral microbiota and oral health in young adults. the hypothesis is that a sedentary lifestyle and high-level sport induce depletion and/or changes in the oral microbiota compared to regular physical activity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microbial Colonization

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sedentary
Arm Type
Other
Arm Description
Participant does not meet WHO's recommendations with the physical activity
Arm Title
OMS recommandations
Arm Type
Other
Arm Description
Participant does not meet WHO's recommendations (2.5-5 hours per week of moderate physical activity OR 1.25-2.5 hours per week of vigorous physical activity);
Arm Title
More than the OMS recommandations
Arm Type
Other
Arm Description
Participant is practicing physical activity more than the WHO recommendations
Intervention Type
Other
Intervention Name(s)
salivar and gum sampling
Intervention Description
Saliva will then be collected by salivary spit and a mucosal smear will be taken using a swab passed at the junction of the tooth and the gum
Primary Outcome Measure Information:
Title
Analysis of the oral microbiota in healthy individuals engaged in endurance physical activity at different levels.
Description
Microbiological screening will be performed using an innovative methodology based on microfluidic PCR (BiomarkHD) (number of bacterial colonies)
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Quantification of salivary inflammatory markers in healthy individuals who perform endurance physical activity at different levels.
Description
numer and type of salivary inflammatory markers will performed using multiplex analysis technology developed by the firm Meso Scale Diagnostic (MSD).
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Be between 18 and 30 years old If practicing sports, it must be an endurance sport as main activity (cycling or running) Exclusion Criteria: Practice more than 3 hours of swimming per week Have taken anti-inflammatory drugs, less than 48 hours before the study Have taken antibiotics and/or probiotics, less than 3 weeks before the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margaux DUBOIS, PH
Phone
0489152267
Email
Margaux.DUBOIS@univ-cotedazur.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Morgane Ortis, PH
Phone
0489152267
Email
Morgane.ORTIS@univ-cotedazur.fr
Facility Information:
Facility Name
Nice University Hospital
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaux Dubois
Phone
04.89.15.22.67
Email
Margaux.DUBOIS@univ-cotedazur.fr
First Name & Middle Initial & Last Name & Degree
Morgane Ortis
Phone
0489152267
Email
Morgane.ORTIS@univ-cotedazur.fr
First Name & Middle Initial & Last Name & Degree
Margaux Dubois

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Influence of Endurance Sports Activity on the Oral Microbiota of Young Adults.

We'll reach out to this number within 24 hrs