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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a low-carbohydrate breakfast can help people with type 2 diabetes better control their blood sugar levels. The focus is on reducing high blood sugar spikes that often occur in the morning after breakfast, which are linked to heart disease and other health problems. Participants will have either a low-carb breakfast or a low-fat breakfast to compare the effects. Suitable candidates have been diagnosed with type 2 diabetes, have maintained stable medication for at least three months, and do not use insulin or have dietary restrictions like avoiding eggs. As an unphased trial, this study offers a unique opportunity to contribute to understanding dietary impacts on diabetes management.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that low-carbohydrate diets are generally safe for people with type 2 diabetes. These diets can help control blood sugar without causing major side effects. For instance, a review of studies found that low-carb diets can even lead to diabetes remission and reported no serious negative effects. Another study found that these diets helped manage diabetes better than other diets over six months. While this trial focuses on a low-carb breakfast, overall research suggests that low-carb eating is well-tolerated and could be a safe choice for those interested. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the low-carbohydrate breakfast for managing Type 2 diabetes because it offers a dietary approach that could better control blood sugar levels compared to traditional low-fat diets. Unlike medications that often focus on insulin production or sensitivity, this approach directly impacts glucose levels by reducing carbohydrate intake, which is the body's main source of glucose. This method could potentially minimize the need for medication, making it appealing for those looking for more natural, lifestyle-based management of their condition. Additionally, it may lead to improved overall metabolic health and weight management, which are key concerns for individuals with Type 2 diabetes.

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

Research has shown that low-carbohydrate diets can help people with type 2 diabetes manage their blood sugar levels. In one study, participants saw their HbA1c levels, which indicate average blood sugar over time, drop by 0.29% in just three months. Another study found that 57% of people on low-carb diets experienced diabetes remission, meaning their blood sugar returned to a healthier range. Additionally, research on low-carb breakfasts showed significant improvements in the time participants spent with healthy blood sugar levels. This trial will compare a low-carbohydrate breakfast with a low-fat control breakfast to evaluate their effects on blood sugar management in type 2 diabetes. These findings suggest that starting the day with a low-carb breakfast could effectively manage blood sugar in type 2 diabetes. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

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

Effectiveness of low-carbohydrate diets on type 2 diabetes LCDs improved glycemia short-term: HbA1c − 0.29 %, with the largest effect at 3 months. Fasting blood glucose decreased overall (−7.12 mg/dL). Weight loss was ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK551953/

Low Carbohydrate Diets for Diabetes: A Review of the Clinical ... One NMA found that low carbohydrate diets were significantly more effective in reducing triglyceride levels compared with the control diets, but ...

3. 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 ...

4. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(23)48890-9/fulltext

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. nature.com nature.com/articles/s41598-024-76584-7

One-year outcomes of a digital twin intervention for type 2 ... A study on low-carbohydrate versus low-fat breakfasts in T2D patients reported significant improvements in TIR with the low-carbohydrate ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11147446/

Low-Carbohydrate and Ketogenic Dietary Patterns for Type ... A systematic review and meta-analysis looking at RCTs of LC diets found evidence for remission of T2DM without significant adverse effects (AEs).