Type 2 DiabetesNCT05986097
The Breakfast Study
A study testing Breakfast in people with Type 2 Diabetes, run by University of Michigan at 1 site in United States.
Trial summary
The investigators conducted an acceptability, feasibility, preliminary effectiveness trial of a 4-month, online, very low-carbohydrate breakfast-focused program in 120 adults with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Breakfast
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2023to 17 Oct 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HbA1c 7% or higher
- 18-80 years old
- The ability to understand verbal and written English
- Willingness to follow the prescribed diet
- Able to consent and follow directions
- Willingness to regularly check blood glucose levels as required
Who cannot join
- Inability to provide informed consent
- Pregnant, breastfeeding, or planning for either in the next 6 months or <6 months postpartum
- Low C-peptide and possible subsequent GAD 65 level that suggests type 1 diabetes, clinical factors that suggest type 1 diabetes (lean, lack of family history, and diabetic ketoacidosis in the past) or a previous diagnosis of type 1 diabetes or latent autoimmune diabetes
- Triglycerides are greater than 999mg/dL on the screening blood draw
- Cancer, heart failure, or kidney failure
- Vegan
Show all 14Show fewer
- Untreated mental health condition
- Currently following a very low-carbohydrate diet or breakfasts
- Thyroid levels out of range
- Alcoholism
- Previous bariatric surgery
- Difficulty chewing or swallowing
- Dependence on others for food preparation
- Currently enrolled in another investigative study that might conflict with this research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Breakfast Study: A Small Steps, Low-literacy, Breakfast-focused Dietary Self-management Intervention for Adults With Poorly Controlled Type 2 Diabetes
The investigators conducted 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 measured acceptability and feasibility, plus critical efficacy outcomes, such as changes in HbA1c, anti-hyperglycemic medications, glycemic variability, body weight, blood pressure, and lipids.
Read the detailed description
More than 15% of U.S. adults with type 2 diabetes have poorly controlled blood glucose, here defined as a glycated hemoglobin (HbA1c) level of 7.0% or higher. These adults have an elevated health risk of a variety of outcomes, including amputation and mortality from cardiovascular disease and from all causes. Nutrition- focused interventions can be effective for improving glycemic control, reducing anti-hyperglycemic medications, and reducing body weight, all of which are critical outcomes for adults with type 2 diabetes. However, typical nutrition-focused interventions can be burdensome, often requiring complex instructions and a complete overhaul of one's diet. Additionally, adults with poorly controlled type 2 diabetes are more likely to have low literacy levels, which can be a barrier for adherence to complex interventions. Therefore, an effective intervention for adults with poorly controlled diabetes who may have lower health literacy levels is necessary to reduce both HbA1c levels and anti-hyperglycemic medications. Carbohydrate intake has the strongest impact on post-prandial glycemia of any dietary factor, and a very low-carbohydrate diet-due to its ability to improve glycemic control-is now recommended by the American Diabetes Association (ADA) for the treatment of type 2 diabetes. The investigators hypothesized that some of the benefits of a very low-carbohydrate diet may be available to individuals who change only their breakfasts to be very low-carbohydrate, rather than modifying their entire diet.
Thus, the investigators conducted an acceptability, feasibility, preliminary effectiveness trial of a 4-month, online, small- steps, low-literacy, very low-carbohydrate breakfast-focused program in 120 adults with poorly controlled type 2 diabetes. The investigators measured acceptability and feasibility, plus critical efficacy outcomes, such as changes in HbA1c, anti-hyperglycemic medications, glycemic variability, body weight, blood pressure, and lipids.
The investigators also tested whether factors such as sex, health literacy level, and baseline insulin resistance significantly moderate the impact of the intervention on change in HbA1c and change in anti-hyperglycemic medications.
- Conditions
- Type 2 Diabetes
- Being tested
- Breakfast
- Keywords
- Very low carbohydrate diet, Nutrition therapy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreakfastBehavioural
Participants were provided recipes and information to support this dietary change.
| Study group | Role | What they receive |
|---|---|---|
| Very low-carbohydrate breakfast | Experimental | Materials encouraged eating a very low-carbohydrate breakfast (or first meal of the day), with no more than about 5-10 non-fiber (net) grams of carbohydrates each. Receives: Behavioral: Breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Satisfaction
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.
Measured: At 4 months
Assessment of Program Feasibility
For feasibility, the percentage of completed sessions out of 16 possible sessions was calculated for each participant, and the mean percentage across participants was reported.
Measured: At Month 4
Secondary outcomes (11)
Weekly Dietary Adherence
A 1-item measure about dietary adherence. We asked participants to reflect on the past week and rate whether they ate a low-carbohydrate breakfast. The item was rated from 1 = not at all to 7 = very much so, with higher scores reflecting greater adherence. Dietary adherence was collected weekly over the 4-month intervention. Average adherence across the intervention was reported.
Measured: Weekly over 4 months
Change in PROMIS Sleep Disturbance T-score
The 4-item PROMIS sleep disturbance subscale measures the extent to which patients experience problems with sleep over the past 7 days using a 5-point Likert scale. The subscale is measured using T-scores (mean 50, SD 10), with higher scores reflecting more severe sleep problems. To assess the effect of dietary change on sleep disturbance, the change in PROMIS sleep disturbance T-scores from baseline to 4 months was evaluated.
Measured: Baseline, 4 months
Change in PROMIS Pain Interference T-score
The 4-item PROMIS subscale for pain interference measures the extent to which patients experience problems with pain interference over the past 7 days using a 5-point Likert scale. The subscale is measured using T-scores (mean 50, SD 10), with higher scores reflecting greater pain interference. To assess the effects of dietary changes on pain, the change in PROMIS pain interference T-scores from baseline to 4 months was evaluated.
Measured: Baseline, 4 months
Change in PROMIS Anxiety T-score
The 4-item PROMIS subscale for anxiety measures the extent to which patients experience depressive symptoms over the past 7 days using a 5-point Likert scale. The subscale is measured using T-scores (mean 50, SD 10), with higher scores reflecting greater depression. To assess the effects of dietary changes on anxiety, the change in PROMIS anxiety T-scores from baseline to 4 months was evaluated.
Measured: Baseline, 4 months
Change in PROMIS Depression T-score
The 4-item PROMIS subscale for depression measures the extent to which patients experience depressive symptoms over the past 7 days using a 5-point Likert scale. The subscale is measured using T-scores (mean 50, SD 10), with higher scores reflecting greater depression. To assess the effects of dietary changes on depression, the change in PROMIS depression T-scores from baseline to 4 months was evaluated.
Measured: Baseline, 4 months
Change in PROMIS Fatigue T-score
The 4-item PROMIS subscale for fatigue measures the extent to which patients experience problems with fatigue over the past 7 days using a 5-point Likert scale. The subscale is measured using T-scores (mean 50, SD 10), with higher scores reflecting greater fatigue. To assess the effects of dietary changes on fatigue, the change in PROMIS fatigue T-scores from baseline to 4 months was evaluated.
Measured: Baseline, 4 months
Change in PROMIS Physical Function T-score
The 4-item PROMIS subscale for physical function measures the extent to which patients experience problems with physical function over the past 7 days using a 5-point Likert scale. The subscale is measured using T-scores (mean 50, SD 10), with higher scores reflecting better physical function. To assess the effects of dietary changes on physical function, the change in PROMIS physical function T-scores from baseline to 4 months was evaluated.
Measured: Baseline, 4 months
Change in PROMIS Social Roles T-score
The 4-item PROMIS subscale for social roles measures the extent to which patients experience problems with their social roles over the past 7 days using a 5-point Likert scale. The subscale is measured using T-scores (mean 50, SD 10), with higher scores reflecting better social roles. To assess the effects of dietary changes on social roles, the change in PROMIS social roles T-scores from baseline to 4 months was evaluated.
Measured: Baseline, 4 months
Change in PROMIS Pain Intensity
The 1-item PROMIS subscale for pain intensity measures average pain intensity over the past 7 days using a 10-point Likert scale, with higher scores reflecting greater pain. To assess the effects of dietary changes on pain intensity, the change in PROMIS pain intensity score from baseline to 4 months was evaluated.
Measured: Baseline, 4 months
Change in HbA1c
HbA1c is the proportion of hemoglobin in the blood that has glucose attached to it relative to total hemoglobin. It reflects average blood glucose levels over approximately the previous 2-3 months. To assess the effect of dietary change on HbA1c, the change in HbA1c from baseline to 4 months were evaluated. A negative change indicates an improvement in HbA1c from baseline.
Measured: Baseline, 4 months
Change in Anti-hyperglycemic Medications
The Medication Effect Score (MES) quantifies the overall intensity of antiglycemic therapy based on potency and dosages of medications (Alexopoulos et al., 2021), with higher scores indicating greater medication intensity. It is interpreted as the reduction in HbA1c attributable to the medication regime. For each diabetes medication, the percentage of the maximum recommended daily dose is multiplied by an adjustment factor reflecting its expected hemoglobin A1c-lowering potency; these values are summed to yield the total MES. Scores range from 0 upward (no fixed maximum), with lower scores reflecting lower medication intensity. The change in MES from baseline to 4 months was evaluated, with negative values indicating a reduction in medication intensity.
Measured: Baseline, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start2 Aug 2023
- Primary completion9 Oct 2025
- Study completion17 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants were provided the same intervention.
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Saslow, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986097
- Sponsor's protocol ID
- HUM00225646
- Other IDs
- 5R01DK132099-03
- Status last verified
- Oct 2026
- First submitted
- 17 Jul 2023
- Last updated
- 19 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hansen A, Raymond K, Simon A, Kim S, Bayandorian H, Marriott D, Saslow LR. Very Low-Carbohydrate Breakfast Intervention for Adults with Type 2 Diabetes and Persistent Hyperglycemia: Protocol for a Digital, Nonrandomized Pre-Post Study. JMIR Res Protoc. 2026 Jan 28;15:e81041. doi: 10.2196/81041.
PubMed 41605502