Clinical trial NCT04538482: DASH INtervention to INvestigate the Gut
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Microbiota
Cancer
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-09-04
Enrollment: 112
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean change in alpha diversity
timeFrame: baseline - day 28
measure: Mean change in alpha diversity
timeFrame: day 28 - day 42
measure: Diet specific changes in secondary bile acids
timeFrame: baseline - day 28
measure: Diet specific changes in secondary bile acids
timeFrame: day 28 - day 42
measure: Diet-specific changes in inflammatory marker
timeFrame: baseline - day 28
measure: Diet-specific changes in inflammatory marker
timeFrame: day 28 - day 42
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Tiffany L Carson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carson TL, Buro AW, Miller D, Pena A, Ard JD, Lampe JW, Yi N, Lefkowitz E, William VP, Morrow C, Wilson L, Barnes S, Demark-Wahnefried W. 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. Contemp Clin Trials. 2022 Dec;123:106968. doi: 10.1016/j.cct.2022.106968. Epub 2022 Oct 18.