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Modifying Diet to Improve Gut Microbiome

StatusNot Yet Recruiting
PhaseNot applicable
Started2027-07
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Aug 2026 → Aug 2027
See other at-risk trials from H. Lee Moffitt Cancer Center and Research Institute

Amendment history

2026-09-18
critical
Primary completion pushed: 2026-08 → 2027-08
Completion pushed: 2026-08 → 2027-08
2025-09-09
minor
Study Status v16
Primary completion date2026-06→2026-08
Completion date2026-06→2026-08
Start date2025-07→2026-07
2025-03-04
minor
Study Status v15
Primary completion date2025-06→2026-06
Completion date2025-06→2026-06
Start date2025-02→2025-07
2025-01-07
minor
Study Status v14
Start date2024-12→2025-02
2024-10-16
minor
Study Status v13
Start date2024-09→2024-12
Show 12 earlier versions
2024-07-03
minor
Study Status v12
Start date2024-06→2024-09
2023-06-20
minor
Study Status v11
Start date2023-06→2024-06
2023-01-10
minor
Study Status v10
Primary completion date2022-12→2025-06
Completion date2023-12→2025-06
Start date2022-12→2023-06
2022-10-20
minor
Study Status v9
Primary completion date2022-09→2022-12
Completion date2023-09→2023-12
Start date2022-09→2022-12
2022-05-10
minor
Study Status v8
Start date2022-04→2022-09
2021-12-20
minor
Study Status v7
Start date2021-09→2022-04
2021-04-15
minor
Study Status, Document Section v6
Re-verified, no change to tracked fields
2021-04-12
notable
Recruiting→Not Yet Recruiting Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations, Document Section v5
Trial statusRecruiting→Not Yet Recruiting
Primary completion date2020-12→2022-09
Completion date2021-01→2023-09
Start date2019-08-05→2021-09
Lead sponsorUniversity of Alabama at Birmingham→H. Lee Moffitt Cancer Center and Research Institute
Study sites1 entry, revised
UniversityMoffit ofCancer Alabama at BirminghamCenter
2020-06-23
minor
Study Status v4
Primary completion date2020-04→2020-12
Completion date2020-04→2021-01
2019-10-22
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2019-09→confirmed 2019-08-05
Study sitesdetails revised at 1 of 1 site
2019-06-07
minor
Study Status v2
Primary completion date2019-12→2020-04
Completion date2020-12→2020-04
Start date2019-05→2019-09
2019-05-06
minor
Study Identification, Study Status v1
Re-verified, no change to tracked fields
2019-04-19
minor
Original filing
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.
Trial Details
NCT Number NCT03924778
Lead Sponsor H. Lee Moffitt Cancer Center and Research Institute
Conditions Obesity
Enrollment 28 participants
Start Date 2027-07
Primary Completion 2027-08 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-09-17