H. Lee Moffitt Cancer Center and Research Institute
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.
Microbiota
Cancer
DASH Diet
standard American diet
NA
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 112 participants |
| Masking : | DOUBLE |
| Primary Purpose : | PREVENTION |
| 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 |
| Actual Study Start Date : | 2022-03-07 |
| Estimated Primary Completion Date : | 2026-05-31 |
| Estimated Study Completion Date : | 2026-05-31 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 19 Years to 65 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: | 1 |
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RECRUITING
Moffitt Cancer Center
Tampa, Florida, United States, 33612