Low-Carbohydrate Breakfast for Type 2 Diabetes

Overseen By Barbara Oliveira, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must not be taking: Exogenous insulin

Disqualifiers: Cancer, Auto-immune, Kidney disorders, others

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

Compensation: Varies

Number of Visits: 2

Duration: 12 months

280 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be on stable medication for at least 3 months to participate.

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

Research suggests that consuming a breakfast with slow-release carbohydrates, like muesli, can improve carbohydrate metabolism and reduce insulin needs in people with type 2 diabetes. Additionally, breakfasts high in whole grains and fiber, while limiting rapidly available carbohydrates, are linked to better metabolic health. ^{1 2 3 4 5}

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

Research suggests that low-carbohydrate diets are generally safe for people with type 2 diabetes and can improve overall health, though concerns about safety remain. It's important to note that people with certain conditions, like reactive hypoglycemia, may not respond well to low-carbohydrate, high-protein diets. ^{2 3 6 7 8}

How does a low-carbohydrate breakfast help manage type 2 diabetes?

A low-carbohydrate breakfast for type 2 diabetes is unique because it focuses on reducing rapidly available carbohydrates, which can help improve blood sugar control throughout the day. This approach may enhance insulin sensitivity and reduce blood sugar spikes after meals, making it a promising strategy for managing type 2 diabetes. ^{1 2 5 7 9}

What is the purpose of this trial?

Type 2 diabetes (T2D), a prevalent metabolic disorder impacting \>3 million Canadians, is characterized by insulin resistance and high blood glucose. Chronically elevated blood glucose (i.e., hyperglycemia) and swings in glucose (i.e., glucose variability) contribute to complications of T2D. Specifically, post-meal hyperglycemic spikes are independent risk factors for cardiovascular disease and mortality. People with T2D often exhibit a different circadian pattern from healthy individuals, with higher glucose excursions in the morning, after breakfast. This makes breakfast a crucial meal in achieving glycemic control. One strategy to reduce or eliminate this high glucose excursion is to consume a low-carbohydrate breakfast. Our recently published 3-month clinical trial (Oliveira et al., AJCN 2023) - funded by the Egg Farmers of Canada (EFC) \& Egg Nutrition Center (ENC) - highlighted the positive impact of a simple dietary intervention, where individuals were advised to consume an egg-based, low-carbohydrate breakfast. This intervention led to improved glycemic control assessed by continuous glucose monitoring and reduced overall energy and carbohydrate intake when compared to a low-fat guideline breakfast. While we saw a within-group reduction HbA1c in the egg-based low-carbohydrate breakfast group, the between group difference did not reach statistical significance. Since HbA1c reflects the average glucose over the preceding 3 months, likely, our previous study's duration was not long enough to demonstrate significant reductions in HbA1c. For a low-carbohydrate breakfast to be recognized as an evidence-based strategy in nutrition and clinical practice guidelines, a longer-term study that demonstrates reductions in HbA1c is needed. Collectively, our promising early results demonstrate that the time is right and that our team is poised to deliver a longer, well-powered randomized controlled trial (RCT) to solidify low-carbohydrate breakfasts as an evidence-based strategy to improve glucose control and improve health outcomes for people living with T2D.

Eligibility Criteria

This trial is for individuals aged 30-79 with physician-diagnosed Type 2 Diabetes who have been on stable medication for at least three months. It aims to help those looking to improve their blood sugar control through dietary changes.

Inclusion Criteria

I have type 2 diabetes, am between 30-79 years old, and have been on stable medication for at least 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline assessments including blood tests, anthropometry, and glucose monitoring

2 weeks

1 visit (in-person) for blood tests, virtual assessments for anthropometry

Treatment

Participants consume either a low-carbohydrate or low-fat breakfast daily for 1 year

12 months

Remote monitoring with periodic virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person) for final assessments

Treatment Details

Interventions

• Low-carbohydrate breakfast
• Low-fat Control breakfast

Trial Overview The study tests the effects of a low-carbohydrate breakfast versus a low-fat control breakfast on blood sugar levels in people with Type 2 Diabetes over an extended period, building upon previous research that suggested potential benefits.

Participant Groups

Group I: Low-carbohydrate breakfast Experimental Treatment 1 Intervention

Group II: Low-fat Control breakfast Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Findings from Research

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]

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]

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]

A 4-week study involving 13 men with type 2 diabetes showed that consuming a low-glycemic index breakfast significantly reduced post-meal plasma glucose levels and cholesterol compared to a high-glycemic index breakfast.

The low-glycemic index breakfast, which included whole grain bread and oats with beta-glucan, improved glycemic control and lowered cholesterol levels, potentially reducing the risk of cardiovascular complications in diabetic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Four-week low-glycemic index breakfast with a modest amount of soluble fibers in type 2 diabetic men. Kabir, M., Oppert, JM., Vidal, H., et al.[2022]

Low-carbohydrate diets have shown positive results in treating diabetes, pre-diabetes, metabolic syndrome, and obesity, with evidence from randomized trials and meta-analyses indicating they are safe and effective for improving health outcomes in diabetic patients.

These diets can lead to significant benefits such as weight loss, reduced medication needs, and even remission in some cases of type 2 diabetes, although they are not yet widely recognized in Czech diabetology due to ongoing safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-carbohydrate diet in diabetes mellitus treatment. Krejčí, H., Vyjídák, J., Kohutiar, M.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

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

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

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

4. Ireland pubmed.ncbi.nlm.nih.gov

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

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

Four-week low-glycemic index breakfast with a modest amount of soluble fibers in type 2 diabetic men. [2022]

6. Czech Republic pubmed.ncbi.nlm.nih.gov

Low-carbohydrate diet in diabetes mellitus treatment. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Glycaemic responses to commonly ingested breakfasts in children with insulin-dependent diabetes mellitus. [2019]

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

Effects of carbohydrate restriction on glucose tolerance of normal men and reactive hypoglycemic patients. [2018]

9. Venezuela pubmed.ncbi.nlm.nih.gov

[Effect of a high fat or high carbohydrate breakfast on postprandial lipid profile in healthy subjects with or without family history of type 2 diabetes mellitus]. [2016]