DASH INtervention to INvestigate the Gut

Cancer Clinical Trial

— DINING  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04538482
• Other study ID #: MCC-21224
• Secondary ID: R01CA253219
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2022
• Est. completion date: May 31, 2026

Study information

• Verified date: February 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Alissa Pena
• Phone: 813-745-7710
• Email: Alissa.Pena[@]moffitt.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Microbiota

Intervention

Behavioral:
• DASH Diet
Participant will receive foods following the DASH dietary pattern for 28 days.
• standard American diet
Participants will receive foods following the standard American diet for 28 days.

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in alpha diversity	The investigators will assess the difference in alpha diversity determined by analyzing fecal samples.	baseline - day 28
Primary	Mean change in alpha diversity	The investigators will assess the difference in alpha diversity determined by analyzing fecal samples.	day 28 - day 42
Primary	Diet specific changes in secondary bile acids	The investigators will calculate changes in cholic acid in milligrams	baseline - day 28
Primary	Diet specific changes in secondary bile acids	The investigators will calculate changes in cholic acid in milligrams	day 28 - day 42
Primary	Diet-specific changes in inflammatory marker	The investigators will calculate changes in interleukin-6 in pg/L	baseline - day 28
Primary	Diet-specific changes in inflammatory marker	The investigators will calculate changes in interleukin-6 in pg/L	day 28 - day 42