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DASH INtervention to INvestigate the Gut

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04538482
Acronym
DINING
Enrollment
115
Registered
2020-09-04
Start date
2022-03-07
Completion date
2026-05-31
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microbiota, Cancer

Brief summary

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.

Interventions

BEHAVIORALDASH Diet

Participant will receive foods following the DASH dietary pattern for 28 days.

Participants will receive foods following the standard American diet for 28 days.

Sponsors

H. Lee Moffitt Cancer Center and Research Institute
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* black or white race * non-Hispanic ethnicity * age 19-65 years * able to travel to the UAB Bionutrition Unit daily to retrieve meals

Exclusion criteria

* gastrointestinal (GI) conditions i.e., irritable bowel, diverticulitis, peptic ulcers, Crohn's, GI cancers, and adenatomous polyps * antibiotic or probiotic use in the previous 90 days * smoking/tobacco use * heavy alcohol consumption * major medical conditions (e.g., renal disease, diabetes, cancer

Design outcomes

Primary

MeasureTime frameDescription
Mean change in alpha diversitybaseline - day 28The investigators will assess the difference in alpha diversity determined by analyzing fecal samples.
Diet specific changes in secondary bile acidsbaseline - day 28The investigators will calculate changes in cholic acid in milligrams
Diet-specific changes in inflammatory markerbaseline - day 28The investigators will calculate changes in interleukin-6 in pg/L

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORTiffany L Carson, PhD

Moffitt Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026