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

120 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the low-carb breakfast treatment for type 2 diabetes?

Research shows that a big breakfast rich in protein and fat can improve blood sugar control in people with type 2 diabetes. Additionally, switching from standard cereals to slow-release starch cereals at breakfast can improve carbohydrate metabolism and reduce insulin needs, suggesting that a low-carb breakfast may be beneficial. ^{1 2 3 4 5}

Is a low-carb breakfast safe for people with type 2 diabetes?

Research suggests that consuming a breakfast high in whole grains, cereal fiber, proteins, and unsaturated fats, while limiting rapidly available carbohydrates, is generally safe and may promote better metabolic health in people with type 2 diabetes. ^{1 2 3 4 6}

How does the low-carb breakfast treatment for type 2 diabetes differ from other treatments?

The low-carb breakfast treatment for type 2 diabetes is unique because it focuses on reducing rapidly available carbohydrates at breakfast, which can improve insulin sensitivity and lower blood sugar levels throughout the day. This approach contrasts with other treatments that may not specifically target breakfast composition or timing. ^{2 3 4 5 6}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Big breakfast rich in protein and fat improves glycemic control in type 2 diabetics. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Breakfast glycaemic response in patients with type 2 diabetes: effects of bedtime dietary carbohydrates. [2019]

3. United States 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. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Do all patients with type 2 diabetes need breakfast? [2016]

5. Ireland pubmed.ncbi.nlm.nih.gov

The effect of muesli or cornflakes at breakfast on carbohydrate metabolism in type 2 diabetic patients. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The Effects of Breakfast Consumption and Composition on Metabolic Wellness with a Focus on Carbohydrate Metabolism. [2023]