๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-09-09

Modifying Diet to Improve Gut Microbiome (NCT03924778)

Modifying Diet and the Gut Microbiota to Reduce Obesity and Health Disparities

๐ŸŸก Not Yet Recruiting Observational / Diagnostic ๐Ÿง  Behavioral & Psychological Program Sponsor: H. Lee Moffitt Cancer Center and Research Institute

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The investigators will conduct a 2-arm randomized controlled pilot, feasibility feeding study in which 28 participants will be randomized to receive either a calorie-restricted Dietary Approaches to Stop Hypertension (DASH) diet or a calorie-restricted standard American diet provided by the study for 4 weeks. Participants will be non-Hispanic black or white, generally healthy females (14 black, 14 white). The investigators will collect fecal samples at multiple time points before, during, and after the dietary intervention to analyze for changes in the gut microbiota and functional-level metabolic products. This work will be led by an interdisciplinary team including expertise in bio-behavioral science, microbiology, nutrition science, bioinformatics, and biostatistics all with cross-cutting expertise in health disparities, prevention research, nutrition, the gut microbiota, inflammation and other biomarkers. The rationale for the proposed research is that once the interactions between race, diet, and the gut microbiota are more fully understood, targeted diet modifications may provide new and innovative approaches for the prevention and treatment of obesity and obesity-related diseases.

Who can join: Review the eligibility criteria below.

Location: Moffit Cancer Center โ€” Tampa, Florida

Age range: 18 Years

๐Ÿงช Interventions in This Study

  • DASH diet (BEHAVIORAL)
  • standard American diet (BEHAVIORAL)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Moffit Cancer Center โ€” Tampa, Florida

๐Ÿ“ž Contact the Study Coordinator

Phone: (813) 745-4944

Email: Tiffany.Carson@moffitt.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Obesity clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—