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NCT05658263 · ClinicalTrials.gov registry record · Early Phase 1
Bacterial Intestinal Gut Modification Around Cancer Surgery (BIG MACS) Diet
A Early Phase 1 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 14
- Enrollment target
NCT05658263: Completed Early Phase 1 study, sponsored by University of Minnesota.
NCT05658263 is a Early Phase 1 study that has completed, run by University of Minnesota. The registered enrollment target is 14 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05658263, a Early Phase 1 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
The long-term study objective is to develop optimized nutritional therapies for surgery and test them in clinical practice. This pilot study will test a microbiome-optimization diet in colorectal cancer surgery patients. The study hypothesizes that the Bacterial Intestinal Gut Modification Around Cancer Surgery (BIG MACS) Diet will provide participants with increased microbiota accessible carbohydrates (MACs) to support the microbiome and improve outcomes.
Primary Outcome
The change in muscle mass assessed by MRI-measured area and density of the psoas muscle at the level of the L3 vertebra with adjunct grip strength measurement.
Interventions
- DIETARY_SUPPLEMENT Standard Diet
- DIETARY_SUPPLEMENT BIG MACS Diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2023-01-03 |
| Est. Completion | 2024-08-15 |
| Phase | Early Phase 1 |
What the finished NCT05658263 record still lists
NCT05658263 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard Diet is the first listed.
NCT05658263 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05658263 about?
NCT05658263 is a clinical study titled "Bacterial Intestinal Gut Modification Around Cancer Surgery (BIG MACS) Diet". The long-term study objective is to develop optimized nutritional therapies for surgery and test them in clinical practice. This pilot study will test a microbiome-optimization diet in colorectal cancer surgery patients. The study hypothesizes that the Bacterial Intestinal Gut Modification Around Ca...
What is the current status of trial NCT05658263?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 14 participants. The study started on 2023-01-03. Estimated completion is 2024-08-15.
What interventions are being tested in trial NCT05658263?
The interventions under investigation include: Standard Diet (DIETARY_SUPPLEMENT), BIG MACS Diet (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05658263?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05658263's enrollment target sits among peer trials
14 1475th of 2000 higher than 498 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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