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NCT05986097 · ClinicalTrials.gov registry record · Phase 1
The Breakfast Study
A Phase 1 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 1
- Development phase
- 119
- Enrollment target
NCT05986097: Completed Phase 1 study, sponsored by University of Michigan.
NCT05986097 is a Phase 1 study that has completed, run by University of Michigan. The registered enrollment target is 119 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05986097, a Phase 1 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 119 participants
- Enrollment target
Study Summary
The investigators will conduct an acceptability, feasibility, preliminary effectiveness trial of a 4-month, online, very low-carbohydrate breakfast-focused program in 120 adults with type 2 diabetes. The investigators will measure acceptability and feasibility, plus critical efficacy outcomes, such as changes in HbA1c, anti-hyperglycemic medications, glycemic variability, body weight, blood pressure, and lipids.
Primary Outcome
A 1-item measure about intervention satisfaction. We asked participants, "How would you rate your overall satisfaction with the program?" The item was rated from 1 = very dissatisfied to 6 = very satisfied, with higher scores reflecting greater satisfaction.
Interventions
- BEHAVIORAL Breakfast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2023-08-02 |
| Est. Completion | 2025-10-17 |
| Phase | Phase 1 |
What the finished NCT05986097 record still lists
NCT05986097 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% higher).
The record links to 0 conditions, and to 1 intervention - of which Breakfast is the first listed.
NCT05986097 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05986097 about?
NCT05986097 is a clinical study titled "The Breakfast Study". The investigators will conduct an acceptability, feasibility, preliminary effectiveness trial of a 4-month, online, very low-carbohydrate breakfast-focused program in 120 adults with type 2 diabetes. The investigators will measure acceptability and feasibility, plus critical efficacy outcomes, such ...
What is the current status of trial NCT05986097?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 119 participants. The study started on 2023-08-02. Estimated completion is 2025-10-17.
What interventions are being tested in trial NCT05986097?
The interventions under investigation include: Breakfast (BEHAVIORAL).
Who is sponsoring clinical trial NCT05986097?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05986097's enrollment target sits among peer trials
119 498th of 2000 higher than 1,502 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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