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Survey of the Collective 16s rRNA Genes From Bacterial Populations From Exercising and Non-exercising Participants

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dental Caries

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants must be between the ages of 18-24 and must be willing and healthy enough to start a modest exercise program if they are chosen, at random, to do so.

Exclusion Criteria:

  • Pregnant women, minors, and people over the age of 24 are excluded from the study.
  • Anyone with a heart condition or other health condition that is not safely able to initiate a modest exercise program are excluded from the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    No Intervention

    Experimental

    Arm Label

    Athlete group

    Non-exercise group

    Exercise group

    Arm Description

    Participants wo regularly exercise and are student athletes.

    Participants who are not student athletes.

    Participants are not student athletes but commit to modest exercise for 5 weeks as part of this study.

    Outcomes

    Primary Outcome Measures

    Changes in DNA sequence of the 16S rRNA gene of each member of the bacterial population in the oral cavity of each participant.
    Changes in DNA sequence of the 16S rRNA genes will be assessed at 5 weeks after an exercise intervention and and compared to baseline populations.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 1, 2015
    Last Updated
    May 10, 2016
    Sponsor
    University of Wisconsin, Madison
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02639455
    Brief Title
    Survey of the Collective 16s rRNA Genes From Bacterial Populations From Exercising and Non-exercising Participants
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2016 (undefined)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    May 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Wisconsin, Madison

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Poor oral health can greatly impact quality of life and can also impact overall health. For instance, research suggests that poor oral health may be associated with systemic diseases such as diabetes, heart disease, and stroke. Therefore, there is a need to investigate the causes of poor oral health. The idea that athletes may have a propensity for dental caries has been gaining traction. There have been recent reports of high levels of dental caries, dental erosion and periodontal diseases among elite soccer players compared to the general public and in athletes from a wide range of sports. However, to date, no studies have investigated the oral microbiome of athletes. Many factors affect the development of dental caries, including host factors, diet, and the microorganisms present in the oral cavity. More than 700 types of bacterial species have been detected in the oral cavity, and some have been identified to play a significant role in the development of oral disease. Streptococcus mutans is the main species involved in dental decay with various lactobacilli also involved in the disease process. Treponema denticola, Porphyromonas ginigivalis, and Aggregatibacter actinomycetemcomitans are the main species involved in periodontal disease. It is not currently known if changes in the collective oral microbiome foster or impede the development of these pathogens. Complex microbe-host interactions occur to allow for the progression of oral disease, with host nutrition and hygiene playing a significant role. Endurance athletes widely consume a variety of sport drinks, gels, and energy bars for supplementation of electrolytes and carbohydrates. The consumption of these foods leads to pH drops in the oral cavity and may contribute to tooth erosion and demineralization. Oral disease may also be exacerbated by the fluid and electrolyte deficit that impedes saliva flow during exercise. However, several studies have failed to demonstrate a clear link between sports drinks and an increased risk of dental caries among athletes. Dental caries are caused by microorganisms in the oral cavity. These microbes may be affected by host factors or nutrition in the progression of oral disease. Due to the documented prevalence of dental caries in athletes and the lack of clear connection between sports drinks and dental caries, the investigators propose to investigate any correlation that may exist between exercise and the oral microbiome.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    165 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Athlete group
    Arm Type
    No Intervention
    Arm Description
    Participants wo regularly exercise and are student athletes.
    Arm Title
    Non-exercise group
    Arm Type
    No Intervention
    Arm Description
    Participants who are not student athletes.
    Arm Title
    Exercise group
    Arm Type
    Experimental
    Arm Description
    Participants are not student athletes but commit to modest exercise for 5 weeks as part of this study.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exercise
    Intervention Description
    Participants will exercise 4 days per week, 20 minutes per session for 5 weeks (a total of 400 minutes). Exercise will be independent (with the goal of 85% of max effort for at least 2 minutes each session) and consist of running, jumping jacks, sit ups, push ups, or burpees depending on the participant's comfort and skill.
    Primary Outcome Measure Information:
    Title
    Changes in DNA sequence of the 16S rRNA gene of each member of the bacterial population in the oral cavity of each participant.
    Description
    Changes in DNA sequence of the 16S rRNA genes will be assessed at 5 weeks after an exercise intervention and and compared to baseline populations.
    Time Frame
    Baseline and 5 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    24 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Participants must be between the ages of 18-24 and must be willing and healthy enough to start a modest exercise program if they are chosen, at random, to do so. Exclusion Criteria: Pregnant women, minors, and people over the age of 24 are excluded from the study. Anyone with a heart condition or other health condition that is not safely able to initiate a modest exercise program are excluded from the study.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    De-identified participant data may be made available within 12 months after completion of the study if the study is published.

    Learn more about this trial

    Survey of the Collective 16s rRNA Genes From Bacterial Populations From Exercising and Non-exercising Participants

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