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Clinical Trials/NCT04538482
NCT04538482CompletedNot Applicable

Determining the structural-and Functional-level Effects of Diet-specific Interventions on the Gut-microbiota of a Diverse Sample of Southern United States Adults

H. Lee Moffitt Cancer Center and Research Institute1 site in 1 country115 target enrollmentStarted: March 7, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
115
Locations
1
Primary Endpoint
Diet-specific changes in inflammatory marker

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
19 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

DASH Diet

Experimental

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

Intervention: DASH Diet (Behavioral)

standard American diet

Active Comparator

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

Intervention: standard American diet (Behavioral)

Outcomes

Primary Outcomes

Diet-specific changes in inflammatory marker

Time Frame: day 28 - day 42

The investigators will calculate changes in interleukin-6 in pg/L

Diet specific changes in secondary bile acids

Time Frame: day 28 - day 42

The investigators will calculate changes in cholic acid in milligrams

Mean change in alpha diversity

Time Frame: day 28 - day 42

The investigators will assess the difference in alpha diversity determined by analyzing fecal samples.

Diet specific changes in secondary bile acids

Time Frame: baseline - day 28

The investigators will calculate changes in cholic acid in milligrams

Mean change in alpha diversity

Time Frame: baseline - day 28

The investigators will assess the difference in alpha diversity determined by analyzing fecal samples.

Diet-specific changes in inflammatory marker

Time Frame: baseline - day 28

The investigators will calculate changes in interleukin-6 in pg/L

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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