DASH INtervention to INvestigate the Gut (DINING)

H. Lee Moffitt Cancer Center and Research Institute

Status: Enrolling

Conditions: Cancer; Microbiota

Treatments: Behavioral: DASH Diet; Behavioral: standard American diet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04538482

R01CA253219 (U.S. NIH Grant/Contract)

MCC-21224

Details and patient eligibility

About

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.

Enrollment: 112 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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112 participants in 2 patient groups

DASH Diet

Experimental group

Description:

calorie-restricted DASH diet (25% fat; 57% carbohydrate; 18% protein; 34 g fiber)

Treatment:

Behavioral: DASH Diet

standard American diet

Active Comparator group

Description:

calorie-restricted standard American diet (35% fat; 51% carbohydrate; %15 protein; 14 g fiber)

Treatment:

Behavioral: standard American diet