DASH INtervention to INvestigate the Gut

NCT04538482 | Completed

• 2 other identifiers: MCC-21224R01CA253219
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Microbiota; Cancer

Outcome Measures

Primary Outcomes (6)

• Mean change in alpha diversity

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

  baseline - day 28

• Mean change in alpha diversity

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

  day 28 - day 42

• Diet specific changes in secondary bile acids

  The investigators will calculate changes in cholic acid in milligrams

  baseline - day 28

• Diet specific changes in secondary bile acids

  The investigators will calculate changes in cholic acid in milligrams

  day 28 - day 42

• Diet-specific changes in inflammatory marker

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

  baseline - day 28

• Diet-specific changes in inflammatory marker

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

  day 28 - day 42

Study Arms (2)

DASH Diet

EXPERIMENTAL

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

Behavioral: DASH Diet

standard American diet

ACTIVE COMPARATOR

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

Behavioral: standard American diet

Interventions

DASH Diet BEHAVIORAL

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

DASH Diet

standard American diet BEHAVIORAL

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

standard American diet

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• black or white race
• non-Hispanic ethnicity
• age 19-65 years
• able to travel to the UAB Bionutrition Unit daily to retrieve meals

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Publications (1)

• 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.

  PMID: 36265810 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Dietary Approaches To Stop Hypertension

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Tiffany L Carson, PhD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2020
• First Posted: September 4, 2020
• Study Start: March 7, 2022
• Primary Completion: March 13, 2026
• Study Completion: March 13, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)