DASH INtervention to INvestigate the Gut

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-07

Study Completion Date

2026-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Microbiota Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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DASH Diet

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

Group Type EXPERIMENTAL

DASH Diet

Intervention Type BEHAVIORAL

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

standard American diet

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

Group Type ACTIVE_COMPARATOR

standard American diet

Intervention Type BEHAVIORAL

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

Interventions

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DASH Diet

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

Intervention Type BEHAVIORAL

standard American diet

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes