Low-Carb Breakfast for Type 2 Diabetes

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Michigan

Disqualifiers: Type 1 diabetes, Cancer, Heart failure, Kidney failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a very low-carb breakfast can help manage type 2 diabetes. Researchers aim to determine if this diet is acceptable, feasible, and effective in improving blood sugar control and body weight. Participants should have type 2 diabetes with an HbA1c level of 7% or higher and be open to trying this new breakfast plan. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to explore this innovative dietary approach.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that low-carbohydrate diets can be safe for people with type 2 diabetes. These diets help control blood sugar levels and improve HbA1c, which measures average blood sugar over time, without major safety concerns.

Reports suggest that most people handle these diets well. Some might initially feel tired or experience headaches, but these symptoms usually subside as the body adjusts. Studies reviewed have not widely reported any serious problems.

Overall, current research indicates that a very low-carbohydrate breakfast is a safe way to help manage type 2 diabetes. ^{1 2 3 4 5}

Why are researchers excited about this possible treatment for type 2 diabetes?

Researchers are excited about the very low-carbohydrate breakfast for type 2 diabetes because it offers a dietary approach that could help manage blood sugar levels naturally. Unlike standard treatments like metformin or insulin that focus on medication to control blood sugar, this approach emphasizes reducing carbohydrate intake to minimize blood sugar spikes after meals. By aiming for a breakfast with only 5-10 grams of net carbs, this method could offer a simple, non-pharmacological way to improve daily blood sugar control, potentially reducing the need for medications.

What evidence suggests that a very low-carbohydrate breakfast might be an effective treatment for type 2 diabetes?

Research shows that eating a very low-carbohydrate breakfast, which participants in this trial will follow, can help manage type 2 diabetes. Studies have found that these breakfasts can slightly lower HbA1c, a measure of average blood sugar levels, by about 0.29%. This diet operates on the idea that fewer carbs can reduce blood sugar spikes after meals. Other research suggests that low-carb breakfasts may improve overall blood sugar control in people with type 2 diabetes. While more studies are needed for confirmation, early results are promising for managing blood sugar. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Adults aged 18-80 with type 2 diabetes, specifically those who have an HbA1c level of 8% or higher and are willing to follow a very low-carbohydrate breakfast program. Participants must understand English, be able to consent and follow instructions, and regularly check their blood glucose levels. Excluded are those already on similar diets, involved in conflicting studies, with certain medical conditions like heart or kidney failure, untreated mental health issues, or specific dietary restrictions like veganism.

Inclusion Criteria

The ability to understand verbal and written English

Willingness to regularly check blood glucose levels as required

Your HbA1c level is 8% or higher.

Exclusion Criteria

You are currently on a diet that contains very few carbohydrates or you often skip breakfast.

You follow a vegan diet.

I rely on someone else to prepare my meals.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 4-month, online, very low-carbohydrate breakfast-focused program

16 weeks

Online program with regular virtual check-ins

Follow-up

Participants are monitored for changes in HbA1c, body weight, blood pressure, and other health metrics

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Breakfast

Trial Overview The study is testing the impact of a very low-carbohydrate breakfast-focused diet over four months on adults with type 2 diabetes. It's online-based and will look at how well participants accept this diet plan (acceptability), can stick to it (feasibility), and its preliminary effectiveness by measuring changes in blood sugar control (HbA1c), medication needs, weight fluctuation, blood pressure variation, and cholesterol levels.

How Is the Trial Designed?

Group I: Very low-carbohydrate breakfast Experimental Treatment 1 Intervention

Materials will encourage 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.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

In a study involving 16 patients with type 2 diabetes, consuming uncooked cornstarch as a bedtime carbohydrate significantly improved glucose tolerance at breakfast the next morning, reducing the glycaemic response by 21% compared to a placebo.

In contrast, eating white bread at bedtime did not provide the same benefit, indicating that slowly digestible carbohydrates like uncooked cornstarch may be more effective for managing blood sugar levels overnight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breakfast glycaemic response in patients with type 2 diabetes: effects of bedtime dietary carbohydrates. Axelsen, M., Arvidsson Lenner, R., Lönnroth, P., et al.[2019]

Withholding breakfast in type 2 diabetes patients led to a reduction in glycemic variability, as indicated by a 32% lower standard deviation in plasma glucose levels compared to when breakfast was included.

The study suggests that not all patients with type 2 diabetes may require breakfast, as the mean plasma glucose level was only slightly higher (0.24 mmol/l) after breakfast, indicating potential flexibility in meal timing without compromising glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do all patients with type 2 diabetes need breakfast? Parkner, T., Nielsen, JK., Sandahl, TD., et al.[2016]

In a study involving 14 overweight insulin-treated type 2 diabetic patients, switching from fast release starch (cornflakes) to slow release starch (muesli) for breakfast led to a significant reduction in plasma insulin levels, indicating improved insulin sensitivity.

The mean day-long plasma glucose levels were 21% lower after consuming muesli compared to cornflakes, demonstrating that slow release starch cereals can enhance carbohydrate metabolism in diabetic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of muesli or cornflakes at breakfast on carbohydrate metabolism in type 2 diabetic patients. Golay, A., Koellreutter, B., Bloise, D., et al.[2022]

In a study involving eight insulin-treated patients with non-insulin-dependent diabetes mellitus (NIDDM), two test breakfasts (meal A and meal B) produced similar plasma glucose and insulin responses, indicating comparable effects on blood sugar control.

A third breakfast (meal C) consisting of toasted muesli and skim milk resulted in significantly lower glucose and insulin responses, suggesting it may be a better option for managing post-meal blood sugar levels in diabetic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of plasma glucose, serum insulin, and C-peptide responses to three isocaloric breakfasts in non-insulin-dependent diabetic subjects. Colagiuri, S., Miller, JJ., Holliday, JL., et al.[2019]

Eating breakfast is linked to better glucose and insulin responses throughout the day, which may lower the risk of type 2 diabetes and metabolic syndrome.

Choosing breakfast foods high in whole grains, fibers, and proteins while reducing rapidly available carbohydrates can improve metabolic health by enhancing insulin sensitivity and promoting better blood pressure and lipid profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Breakfast Consumption and Composition on Metabolic Wellness with a Focus on Carbohydrate Metabolism. Maki, KC., Phillips-Eakley, AK., Smith, KN.[2023]

In a study of 59 overweight adults with type 2 diabetes, a big breakfast (rich in fat and protein) led to greater reductions in HbA1c and systolic blood pressure compared to a small breakfast (rich in carbohydrates) over 3 months.

Participants in the big breakfast group also experienced a significant reduction in their diabetes medication doses, while those in the small breakfast group were more likely to have their medication increased, indicating that a higher protein and fat breakfast may improve metabolic control in T2DM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Big breakfast rich in protein and fat improves glycemic control in type 2 diabetics. Rabinovitz, HR., Boaz, M., Ganz, T., et al.[2015]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0168822725004784

Effectiveness of low-carbohydrate diets on type 2 diabetes LCDs show modest 3-month glycemic improvements: 0.29% HbA1c reduction. · Cultural context significantly influences low-carb diet metabolic ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04550468

Low-carbohydrate Versus Low-fat Breakfast in Type 2 ... It is hypothesized that consuming a low carbohydrate high fat (LCHF) breakfast for 3 months, when compared to a standard low-fat breakfast will improve blood ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37257563/

Impact of a Low-Carbohydrate Compared with Low-Fat ... We investigated if a low-carbohydrate (LC) breakfast (∼465 kcal: 25 g protein, 8 g carbohydrates, and 37 g fat) could improve glucose control in people with T2D

4. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523488909

Impact of a Low-Carbohydrate Compared with Low-Fat ... We investigated if a low-carbohydrate (LC) breakfast (∼465 kcal: 25 g protein, 8 g carbohydrates, and 37 g fat) could improve glucose control in people with T2D

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06814171

Study Details | NCT06814171 | UBC Breakfast Study 2.0 We hypothesize that consuming a low-carbohydrate breakfast for 1-year will improve blood glucose control and be recognized as a scientifically substantiated, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11131143/

Low‐carbohydrate diet for people with type 2 diabetes mellitus A very low‐carbohydrate diet (VLCD) contained 50 g or less of carbohydrates per day or 10% of the total caloric value per day [23]. The VLCD is ...

7. bmj.com bmj.com/content/372/bmj.m4743

Efficacy and safety of low and very low carbohydrate diets ... At six months, compared with control diets, LCDs achieved higher rates of diabetes remission (defined as HbA1c <6.5%) (76/133 (57%) v 41/131 (31 ...

8. diabetesresearchclinicalpractice.com diabetesresearchclinicalpractice.com/article/S0168-8227(25)00478-4/fulltext

Effectiveness of low-carbohydrate diets on type 2 diabetes LCDs show modest 3-month glycemic improvements: 0.29% HbA1c reduction. •. Cultural context significantly influences low-carb diet metabolic responses. •. Short ...