Investigating the effects of the DASH diet on gut microbiota in healthy adults
Determining the structural-and Functional-level Effects of Diet-specific Interventions on the Gut-microbiota of a Diverse Sample of Southern United States Adults
This study is testing whether following the DASH diet for 28 days can improve gut health in healthy adults compared to a standard American diet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 19 Years to 65 Years |
| Sex | All |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute Academic / other |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT04538482 on ClinicalTrials.gov |
What this trial studies
This study recruits 112 generally healthy black and white adults from Birmingham, AL, to participate in a 28-day randomized, controlled feeding intervention. Participants will be assigned to either the DASH diet or a standard American diet, with all meals provided by the study. Fecal samples will be collected at various time points to analyze changes in gut microbiota using advanced sequencing techniques. The study aims to determine if the DASH diet leads to greater improvements in gut microbiota diversity and specific microbial abundances associated with colorectal cancer compared to the standard diet.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 19-65 who identify as black or white and can travel daily to the UAB Bionutrition Unit.
Not a fit: Patients with gastrointestinal conditions, major medical issues, or those who have used antibiotics or probiotics recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary interventions that promote gut health and potentially reduce cancer risk.
How similar studies have performed: While dietary interventions have been explored in various contexts, this specific approach focusing on the DASH diet's impact on gut microbiota is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tampa, Florida
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Tiffany L Carson, PhD — Moffitt Cancer Center
- Study coordinator: Alissa Pena
- Email: Alissa.Pena@moffitt.org
- Phone: 813-745-7710
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.