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

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ClinicalTrials.gov Identifier: NCT02639455
Recruitment Status : Completed
First Posted : December 24, 2015
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date  ICMJE December 1, 2015
First Posted Date  ICMJE December 24, 2015
Last Update Posted Date May 12, 2016
Study Start Date  ICMJE February 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2015)
Changes in DNA sequence of the 16S rRNA gene of each member of the bacterial population in the oral cavity of each participant. [ Time Frame: Baseline and 5 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Survey of the Collective 16s rRNA Genes From Bacterial Populations From Exercising and Non-exercising Participants
Official Title  ICMJE Not Provided
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Dental Caries
Intervention  ICMJE Behavioral: Exercise
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.
Study Arms  ICMJE
  • No Intervention: Athlete group
    Participants wo regularly exercise and are student athletes.
  • No Intervention: Non-exercise group
    Participants who are not student athletes.
  • Experimental: Exercise group
    Participants are not student athletes but commit to modest exercise for 5 weeks as part of this study.
    Intervention: Behavioral: Exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 10, 2016)
165
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2015)
300
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 24 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02639455
Other Study ID Numbers  ICMJE 2015-1268
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: De-identified participant data may be made available within 12 months after completion of the study if the study is published.
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Wisconsin, Madison
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP