RECRUITING

Associations Between the Microbiome, Skeletal Muscle Perfusion, and Fitness Status

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of the study is to determine associations between fitness status, bacteria in the mouth, and the blood flow to muscle. This study is trying to find out if fitness status impacts the bacteria that are present in the oral microbiome (environment in the mouth) or the ability of the body to send blood to the skeletal muscle. Participants will complete all or some of the following: * A mouth swab to assess the bacteria in their mouths. * Produce a saliva sample into a tube. * Cycle on a bike until you reach maximum effort. * Undergo blood draws * Wear a 24-hour non-invasive device that monitors blood pressure. * Undergo a test to assess blood flow to the muscles measured with an ultrasound. * Drink 70mL (1/3 of a cup) of concentrated beetroot juice once

Official Title

Associations Between the Microbiome, Skeletal Muscle Perfusion, and Fitness Status

Quick Facts

Study Start:2023-08-30
Study Completion:2024-08-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06009276

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
  2. * Subjects may be of either sex with age 18 years.
  1. * Oral antibiotic use within previous four weeks
  2. * Oral disease or poor oral health as determined by the Oral Health Questionnaire
  3. * Using an antibacterial mouthwash or a mouthwash containing chlorhexidine and unwilling to discontinue use
  4. * Tobacco smokers
  5. * Pregnant or lactating females
  6. * Hypersensitivity to any ultrasound contrast agent
  7. * Inability to perform exercise
  8. * Unable to communicate effectively in English to the study team.
  9. * Diagnosis of chronic renal failure (GFR \< 60 ml/min/1.73m)
  10. * Subjects taking nitroglycerine (or inorganic nitrates), PDE-5 inhibitors (ex: Cialis, Viagra), and xanthine oxidase inhibitors (ex: Allopurinol).

Contacts and Locations

Study Contact

Casey C Derella, PhD
CONTACT
6092476377
bxg7vn@virginia.edu
Macy E Stahl, B.S.E.d
CONTACT
5719698323
mes4hm@virginia.edu

Principal Investigator

Jason D Allen, PhD
PRINCIPAL_INVESTIGATOR
University of Virginia

Study Locations (Sites)

UVA Student Health and Wellness Building
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: University of Virginia

  • Jason D Allen, PhD, PRINCIPAL_INVESTIGATOR, University of Virginia

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 Registration Dates

Study Start Date2023-08-30
Study Completion Date2024-08-07

Study Record Updates

Study Start Date2023-08-30
Study Completion Date2024-08-07

Terms related to this study

Additional Relevant MeSH Terms

  • Heart Failure, Systolic
  • Heart Failure, Diastolic
  • Peripheral Arterial Disease
  • Overweight and Obesity