NCT04538482: DINING

DASH INtervention to INvestigate the Gut

Active, enrolled NA Last updated 27 March 2026

What this trial tests

NA trial testing DASH Diet in Microbiota in 115 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

7 March 2022

Primary endpoint
12 March 2026

31 May 2026

Quick facts

Lead sponsor	H. Lee Moffitt Cancer Center and Research Institute
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	115
Start date	7 March 2022
Primary completion	12 March 2026
Estimated completion	31 May 2026
Sites	1 location across United States

Drugs / interventions tested

• DASH Diet
• standard American diet

Conditions studied

• Microbiota — all drugs for Microbiota →
• Cancer — all drugs for Cancer →

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Who can join

Adults 19 to 65, any sex, with Microbiota or Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Butyrate as a promising therapeutic target in cancer: From pathogenesis to clinic (Review).
   Sun J, Chen S, Zang D, Sun H, et al · · 2024 · cited 71× · PMID 38426581 · DOI 10.3892/ijo.2024.5632
2. Rationale and study protocol for a randomized controlled feeding study to determine the structural- and functional-level effects of diet-specific interventions on the gut microbiota of non-Hispanic black and white adults.
   Carson TL, Buro AW, Miller D, Peña A, et al · · 2022 · cited 10× · PMID 36265810 · DOI 10.1016/j.cct.2022.106968