The Breakfast Study
NCT05986097 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 119
Last updated 2025-11-21
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.
Conditions
Interventions
- BEHAVIORAL
-
Breakfast
We will provide participants recipes and information to support this dietary change.
Sponsors & Collaborators
- lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-02
- Primary Completion
- 2025-10-09
- Completion
- 2025-10-17
Countries
- United States
Study Locations
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