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Completed

NCT Number: NCT04538482

DASH INtervention to INvestigate the Gut

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.

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Key information

Conditions

Microbiota Cancer Neoplasms

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DASH diet

Behavioral

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

standard American diet

Behavioral

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

Primary outcomes

  1. Mean change in alpha diversity

    Time frame: baseline - day 28

    The investigators will assess the difference in alpha diversity determined by analyzing fecal samples.

  2. Mean change in alpha diversity

    Time frame: day 28 - day 42

    The investigators will assess the difference in alpha diversity determined by analyzing fecal samples.

  3. Diet specific changes in secondary bile acids

    Time frame: baseline - day 28

    The investigators will calculate changes in cholic acid in milligrams

  4. Diet specific changes in secondary bile acids

    Time frame: day 28 - day 42

    The investigators will calculate changes in cholic acid in milligrams

  5. Diet-specific changes in inflammatory marker

    Time frame: baseline - day 28

    The investigators will calculate changes in interleukin-6 in pg/L

  6. Diet-specific changes in inflammatory marker

    Time frame: day 28 - day 42

    The investigators will calculate changes in interleukin-6 in pg/L

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Acronym: DINING

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2020
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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