RECRUITING

DASH INtervention to INvestigate the Gut

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 study investigators will recruit a generally healthy sample of 112 black and white adults from Birmingham, AL to participate in a 28-day randomized, controlled feeding study. Participants will be randomized to receive either the DASH diet or a standard American diet. All meals will be provided by the study. Fecal samples will be collected at multiple time points before, during, and after the dietary intervention and will be analyzed using PCR to amplify the V4 region of the 16S rRNA gene and to sequence bases using the MiSeq platform. Sequenced data will then be analyzed using QIIME. The investigators hypothesize that participants receiving the DASH diet will have a greater increase in alpha diversity and greater changes in abundances of CRC-associated microbes than participants receiving the standard American diet. The investigators will also evaluate functional-level markers including bile acid and short chain fatty acid (SCFA) production and inflammatory markers. If the investigator's hypothesis is supported, they expect to see reduced production of secondary bile acids (e.g., deoxycholic acid), greater SCFA production (e.g, butyrate), and reduction in gut and systemic inflammation (e.g, calprotectin, IL-6) among participants receiving the DASH diet compared to the standard American diet. The investigator's findings will provide preliminary evidence for the DASH diet as an approach for cultivating a healthier gut microbiota across racially diverse populations. These findings can impact clinical, translational, and population-level approaches for modification of the gut microbiota to reduce risk of chronic diseases like CRC.

Official Title

Determining the structural-and Functional-level Effects of Diet-specific Interventions on the Gut-microbiota of a Diverse Sample of Southern United States Adults

Quick Facts

Study Start:2022-03-09
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04538482

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:19 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * black or white race
  2. * non-Hispanic ethnicity
  3. * age 19-65 years
  4. * able to travel to the UAB Bionutrition Unit daily to retrieve meals
  1. * gastrointestinal (GI) conditions i.e., irritable bowel, diverticulitis, peptic ulcers, Crohn's, GI cancers, and adenatomous polyps
  2. * antibiotic or probiotic use in the previous 90 days
  3. * smoking/tobacco use
  4. * heavy alcohol consumption
  5. * major medical conditions (e.g., renal disease, diabetes, cancer

Contacts and Locations

Study Contact

Alissa Pena
CONTACT
813-745-7710
Alissa.Pena@moffitt.org
Tiffany L Carson, PhD
CONTACT
813-745-4944
Tiffany.Carson@moffitt.org

Principal Investigator

Tiffany L Carson, PhD
PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center

Study Locations (Sites)

Moffitt Cancer Center
Tampa, Florida, 33612
United States

Collaborators and Investigators

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

  • Tiffany L Carson, PhD, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center

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 Date2022-03-09
Study Completion Date2026-06

Study Record Updates

Study Start Date2022-03-09
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

  • Microbiota
  • Cancer