Meal Order for Abnormal Glucose Metabolism

Overseen By Patrick Wilson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Old Dominion University

Must not be taking: Insulin

Disqualifiers: Pregnancy, Bariatric surgery, Pacemaker, others

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

Compensation: Varies

Number of Visits: 1

Duration: 90 minutes

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the order of eating different foods in a vegetarian meal affects blood sugar levels and energy use. It aims to determine if eating carbohydrates, like rice, last instead of first can better manage blood sugar. The trial includes two groups: one consumes carbohydrates first (carbohydrate-first meal), and the other consumes them last (carbohydrate-last meal). Suitable participants are those without allergies to edamame, butter, and rice, and who do not require insulin for a medical condition. As an unphased trial, this study offers a unique opportunity to contribute to understanding dietary impacts on blood sugar management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using insulin, you would not be eligible to participate.

What prior data suggests that this meal order protocol is safe?

Research has shown that eating carbohydrates at the end of a meal can help reduce blood sugar spikes. Studies indicate this method is safe and practical for people with prediabetes, with no serious side effects reported.

For meals where carbohydrates are eaten first, less direct evidence exists on safety. However, one study suggested that a high-carb breakfast doesn't cause major changes in heart rate or rhythm, indicating it is generally well-tolerated.

Overall, both eating methods appear safe based on current research, with no significant reports of negative effects for either approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the meal order approach for managing abnormal glucose metabolism because it focuses on the timing of carbohydrate intake rather than medication or invasive procedures. Unlike standard treatments like insulin or oral hypoglycemics, which work by altering insulin levels or improving insulin sensitivity, this method explores how the sequence of meal components might naturally regulate blood sugar. By simply changing whether carbohydrates are eaten first or last, this technique could offer an easy, non-drug method to manage glucose levels, potentially reducing the need for medication and its associated side effects.

What evidence suggests that this trial's treatments could be effective for abnormal glucose metabolism?

This trial will compare the effects of different meal orders on blood sugar levels. Participants will be assigned to one of two groups: one group will consume a carbohydrate-first meal, while the other group will have a carbohydrate-last meal. Research has shown that the order of food consumption during a meal can impact blood sugar levels. Specifically, studies indicate that eating carbohydrates at the end of a meal, rather than at the beginning, may help reduce blood sugar spikes. For instance, one study found that consuming protein and vegetables before carbohydrates can help control blood sugar. Another study suggested that eating carbohydrates last can effectively manage blood sugar after meals. However, these effects can vary from person to person. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with conditions like abnormal glucose metabolism, diabetes, or liver metabolic disorders. It's also relevant for those interested in how food order affects blood sugar and fuel use during rest. Participants should be comfortable with consuming vegetarian meals as part of the study.

Inclusion Criteria

I do not need insulin for any health conditions.

I have never had weight loss surgery.

Free from any allergy or condition that precludes consumption of edamame, butter, and rice

Exclusion Criteria

Currently pregnant

Having an implanted electrical device such as a pacemaker

I use insulin for my medical condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants consume meals with different food orders to assess impact on blood glucose and fuel utilization

90 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Carbohydrate-first meal
• Carbohydrate-last meal

Trial Overview

The study investigates the effects of eating carbohydrates at different times during a meal on blood glucose levels and the body's use of fuel while resting. Participants will eat vegetarian meals with carbs either as the first or last part to see which method is better for managing blood sugar.

How Is the Trial Designed?

Group I: Carbohydrate-last meal Experimental Treatment 1 Intervention

Group II: Carbohydrate-first meal Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Old Dominion University

Lead Sponsor

Trials

25

Recruited

15,500+

Published Research Related to This Trial

In a study involving 10 women with gestational diabetes mellitus (GDM), consuming carbohydrates last in a meal sequence significantly reduced post-meal glucose levels compared to consuming carbohydrates first.

Increasing the number of meals throughout the day also helped lower peak glucose levels and glycemic excursions, suggesting that both meal timing and frequency can be effective strategies for managing blood sugar in GDM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changing Meal Sequence Affects Glucose Excursions in Gestational Diabetes Mellitus. Yong, G., Jing, Q., Yao, Q., et al.[2022]

In a study of 14 healthy men, consuming a low-carbohydrate meal (LCM) in the evening significantly reduced post-meal blood glucose and insulin levels compared to standard meals, indicating improved glucose metabolism.

However, the LCM also led to increased postprandial triglyceride levels, which could raise the risk of arteriosclerosis, suggesting a trade-off between benefits for blood sugar control and potential cardiovascular risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Evening-Only Low-Carbohydrate Meal on Healthy Volunteers. Yaegashi, A., Suzuki, J.[2021]

A study involving 309 participants with poorly controlled type 2 diabetes showed that individualized low-carbohydrate meal replacement diets significantly improved HbA1c levels, weight, and cardiometabolic risk factors after 52 weeks, particularly in those who had three meal replacements per day.

The stringent meal replacement group (three meals/day) achieved a clinically relevant HbA1c reduction of -0.81% after one year, while the moderate group (two meals/day) did not show significant differences compared to the control group, highlighting the importance of meal frequency in managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized Meal Replacement Therapy Improves Clinically Relevant Long-Term Glycemic Control in Poorly Controlled Type 2 Diabetes Patients. Kempf, K., Röhling, M., Niedermeier, K., et al.[2022]

In a study involving 20 children with type 1 diabetes, consuming protein and fat before carbohydrates led to significantly lower post-meal glucose levels, with an average reduction of 1 mmol/L compared to meals where all macronutrients were eaten together.

This method also reduced the time glucose levels exceeded 10 and 12 mmol/L, indicating improved glycemic control and less variability in blood sugar levels after meals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of food order on postprandial glucose levels in children with type 1 diabetes. Faber, EM., van Kampen, PM., Clement-de Boers, A., et al.[2019]

In a 16-week study involving 45 adults with prediabetes, those who followed a carbohydrate-last food order lost an average of 3.6 lbs and showed a trend towards lower HbA1c levels, indicating potential benefits for weight management and blood sugar control.

The carbohydrate-last approach was well-received, with 94% of participants reporting high adherence and an increase in vegetable and protein intake, suggesting it is a feasible strategy to improve diet quality in individuals with prediabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Pilot Study of the Food Order Behavioral Intervention in Prediabetes. Shukla, AP., Karan, A., Hootman, KC., et al.[2023]

Eating carbohydrates after consuming protein or vegetables may help lower postprandial blood glucose and insulin levels, based on a systematic review of 11 studies.

The review suggests that this 'carbohydrate-last' approach could be a simple dietary modification to improve glucose management, particularly for individuals with obesity and cardiometabolic disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ordered Eating and Its Effects on Various Postprandial Health Markers: A Systematic Review. Ferguson, BK., Wilson, PB.[2023]

Eating protein and fat before carbohydrates can improve blood sugar levels after meals by increasing the secretion of GLP-1, which helps regulate insulin and appetite, making it a useful strategy for managing diabetes and obesity.

Combining dietary fiber with this meal sequence approach may further enhance its benefits by reducing post-meal blood sugar spikes, suggesting a potential additive effect for better metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Recent Findings on Meal Sequence: An Attractive Dietary Approach to Prevention and Management of Type 2 Diabetes. Kubota, S., Liu, Y., Iizuka, K., et al.[2021]

The carbohydrate-later meal pattern (CL) showed little to no significant impact on hemoglobin A1c (HbA1c) levels and other metabolic markers in type 2 diabetes patients, based on a systematic review of 230 participants across eight trials.

The evidence regarding the efficacy of CL was of low to very low certainty, and none of the studies assessed quality of life or adverse events, suggesting that CL may not offer additional benefits beyond standard dietary advice for managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a meal sequence in patients with type 2 diabetes: a systematic review and meta-analysis. Okami, Y., Tsunoda, H., Watanabe, J., et al.[2022]

In a study with 15 participants with prediabetes, changing the order of food consumed during a meal significantly reduced post-meal glucose spikes, with the 'protein and vegetables first' (PVF) order leading to a 38.8% lower glucose response compared to 'carbohydrate first' (CF).

The 'vegetables first' (VF) meal condition also resulted in significantly lower insulin levels compared to CF, indicating that meal order can be an effective strategy to stabilize blood sugar levels in individuals with prediabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of food order on postprandial glycaemic excursions in prediabetes. Shukla, AP., Dickison, M., Coughlin, N., et al.[2020]

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