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
About this trial
This is an interventional basic science trial for Dental Caries
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.
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
NCT ID
NCT02639455
First Posted
December 1, 2015
Last Updated
May 10, 2016
Sponsor
University of Wisconsin, Madison
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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