Meal Order for Diabetes

Overseen By Patrick Wilson, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Old Dominion University

Disqualifiers: Cardiovascular disease, Diabetes, Pulmonary disease, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day per condition

30 Participants Needed

Trial Summary

What is the purpose of this trial?

There is well documented evidence that ingesting dietary carbohydrate in large amounts tends to increase postprandial glucose. In healthy populations, this is not necessarily a problem, but continuous exposure to high levels of glucose-hyperglycemia-is a defining characteristic and risk factor for type 2 diabetes mellitus. Consuming a carbohydrate-rich food as the final food in a meal sequence has been shown to significantly reduce postprandial glucose excursions in both diabetes patients and in healthy controls. The exact mechanisms behind this phenomenon are not well understood, but one proposed course is simply that the vegetable and protein already being digested slows the rate of glucose rise. Despite the findings, little-to-no research has examined how manipulating the order of foods in a meal impacts subsequent exercise responses. In this experimental crossover study, each participant will undergo two acute feeding conditions (carbohydrate-rich foods first vs. last in a meal), which will be followed by exercise 60 minutes later. We will observe the effects of meal order on postprandial glucose, substrate/fuel utilization, and subjective perceptions at rest and during 30 minutes of exercise.

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

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Ordered Eating for diabetes?

Research shows that delivering diabetic meals can improve blood sugar control in people with type 2 diabetes, as seen in a study where patients had better HbA1c levels (a measure of blood sugar over time) after receiving diabetic meal deliveries. ^{1 2 3 4 5}

Is the Meal Order for Diabetes treatment safe for humans?

The research does not provide specific safety data for the Meal Order for Diabetes treatment, but it discusses the importance of accurate meal planning and monitoring in hospitals to prevent dietary errors, which can pose safety risks. ^{6 7 8 9 10}

How does the meal order treatment for diabetes differ from other treatments?

The meal order treatment for diabetes is unique because it involves dividing meals into portions with a focus on high protein content in the first portion, which significantly improves blood glucose and insulin responses in diabetic patients, making them more similar to those of non-diabetic individuals. This approach differs from traditional meal planning systems that focus on exchange lists or calorie counting, as it emphasizes the timing and composition of meal components to optimize metabolic responses. ^{6 11 12 13 14}

Research Team

Patrick Wilson

Principal Investigator

Old Dominion University

Eligibility Criteria

This trial is for physically active individuals who can run at a moderate-to-high intensity for at least 30 minutes. Participants should have been exercising regularly, at least three times a week for the past three months.

Inclusion Criteria

Currently physically active (scheduled exercise at least three days per week for 30 minutes each time over the last three months)

Ability to perform moderate-to-high intensity running for at least 30 minutes

Exclusion Criteria

Currently pregnant

Any allergy or other condition that would prohibit the consumption of poultry, rice, or broccoli

Implanted electrical devices such as a pacemaker.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo two acute feeding conditions (carbohydrate-rich foods first vs. last in a meal), followed by exercise 60 minutes later

1 day per condition

2 visits (in-person)

Follow-up

Participants are monitored for postprandial glucose, substrate/fuel utilization, and subjective perceptions at rest and during exercise

2 hours per visit

Treatment Details

Interventions

• Ordered Eating

Trial Overview The study tests how eating carbohydrates either at the beginning or end of a meal affects blood sugar levels and exercise response. Each participant will try both eating orders followed by exercise an hour later to see which method is better for managing glucose during physical activity.

Participant Groups

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+

Findings from Research

The novel FoodforCare meal service significantly improved protein and energy intake among patients compared to the traditional meal service, with notable increases in intake on both the first and fourth days of full oral intake.

Patient satisfaction with the meal service remained stable, but the FoodforCare group reported better satisfaction regarding the appearance and smell of the meals, indicating a positive reception of the new service.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A novel in-hospital meal service improves protein and energy intake]. Dijxhoorn, DN., van den Berg, MGA., Drenth, JPH., et al.[2018]

In a study of 126 hospitalized patients with type 2 diabetes, a flexible meal dosing strategy resulted in similar glucose control compared to a fixed meal dosing strategy, with mean glucose levels of 8.8 mmol/L for flexible dosing and 9.5 mmol/L for fixed dosing.

The flexible meal group experienced a higher frequency of hypoglycemia (39%) compared to the fixed meal group (23%), although this difference was not statistically significant, indicating a need for further research to optimize insulin delivery in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prandial insulin dosing using the carbohydrate counting technique in hospitalized patients with type 2 diabetes. Dungan, KM., Sagrilla, C., Abdel-Rasoul, M., et al.[2021]

A computerized order set for managing diabetes in hospitalized patients improved glycemic control, with 75% of glucose readings in the target range (60-180 mg/dL) compared to 71% in usual care, based on a study of 179 patients.

The intervention group also showed a lower average glucose level (148 mg/dL vs. 158 mg/dL) and reduced reliance on sliding-scale insulin, while maintaining a similar rate of severe hypoglycemia, indicating safety in the new approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a computerized order set on the inpatient management of hyperglycemia: a cluster-randomized controlled trial. Schnipper, JL., Liang, CL., Ndumele, CD., et al.[2022]

In a study of 77 patients with type 2 diabetes over 12 months, a diabetic meal delivery system significantly reduced HbA1c levels from 8.2% to 7.4%, demonstrating its effectiveness in improving glycemic control.

The diabetic meal delivery system was found to be as effective as individual dietary counseling, suggesting it can be a viable option for diabetes management and education in outpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention with delivery of diabetic meals improves glycemic control in patients with type 2 diabetes mellitus. Imai, S., Kozai, H., Matsuda, M., et al.[2022]

A systematic review of five studies involving 720 patients found that electronic bedside meal ordering systems significantly improved patient dietary intake, satisfaction, and reduced plate waste compared to traditional menu systems.

Despite these positive outcomes, the review highlights a need for more research to fully understand the impact of these digital systems on patient and organizational outcomes in hospital foodservices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of electronic bedside meal ordering systems on dietary intake, patient satisfaction, plate waste and costs: A systematic literature review. MacKenzie-Shalders, K., Maunder, K., So, D., et al.[2020]

A new computer program has been created to help diabetic patients by generating personalized meal plans based on their dietary needs, meal patterns, and food preferences.

The program not only produces daily menus that vary each day but also provides nutrient summaries and shopping lists, making it a comprehensive tool for managing diabetes through diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-planned menus for patients with diabetes mellitus. Wheeler, ML., Wheeler, LA.[2019]

In a study of 167 hospitalized patients on therapeutic diets, meal-related errors were found in 8% of the 906 meals assessed, with 97% of these errors classified as critical, highlighting significant safety risks.

The implementation of an electronic foodservice system (EFS) nearly eliminated errors during meal assembly, but critical errors were still prevalent during menu planning and meal delivery, indicating that further improvements are needed in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying errors in meals provided to and sourced by patients on therapeutic diets in hospital. Rattray, M., Desbrow, B., Roberts, S.[2019]

The study found an average tray assembly error rate of 12.9% across 6,553 trays, with the highest errors occurring during evening meals and in the second half of the assembly period.

Only 2.7% of the errors were critical, meaning they contradicted diet orders, indicating that while errors are common, most do not severely impact patient nutrition care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitor of tray error rates for quality control. Dowling, RA., Cotner, CG.[2000]

The revised Exchange List for Meal Planning emphasizes a high-carbohydrate, high-fiber diet for individuals with diabetes, reflecting updated nutritional recommendations and improving educational utility.

A new simplified meal planning tool, Healthy Food Choices, was developed to aid in initial education, grouping foods by calories and allowing nutrition counselors to customize meal plans for clients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exchange lists: revised 1986. Franz, MJ., Barr, P., Holler, H., et al.[2009]

In a study involving 163 hospitalized children, a revised menu with child-friendly labeling significantly increased the selection of healthier 'green-light' food options and reduced 'red-light' items at the first meal.

While the labeling encouraged healthier choices initially, the positive effects diminished over time, indicating that ongoing strategies may be needed to maintain healthy eating habits in children during hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

All Aboard Meal Train: Can Child-Friendly Menu Labeling Promote Healthier Choices in Hospitals? Basak, S., Steinberg, A., Campbell, A., et al.[2019]

Youth with type 1 diabetes showed poorer diet quality on weekends compared to weekdays, with increased energy intake and lower consumption of fruits and vegetables, highlighting the need for targeted nutrition education.

Meals consumed at home generally had better nutrient density than those eaten away from home, particularly for breakfast and dinner, suggesting that meal location significantly impacts dietary quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contextual factors are associated with diet quality in youth with type 1 diabetes mellitus. Nansel, TR., Lipsky, LM., Liu, A., et al.[2021]

Dividing a breakfast into two portions significantly improved blood glucose levels in mild diabetic patients, especially when the first portion was high in protein.

This high-protein meal division not only improved blood glucose responses but also brought the insulin response of diabetic patients closer to that of normal subjects, suggesting that protein-rich meals may be beneficial for managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood glucose and plasma insulin of mild diabetic patients in response to high protein divided meals. Seino, Y., Ikeda, M., Taminato, T., et al.[2011]

The Exchange Lists for Meal Planning, used for over 50 years by individuals with diabetes and those on weight-loss diets, are supported by a comprehensive database that details the energy and macronutrient values of various foods.

The analysis of this database shows that while the average values for food groups align with the Exchange Lists, there is significant variability, which can inform clinical decision-making in meal planning and food labeling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Macronutrient and energy database for the 1995 Exchange Lists for Meal Planning: a rationale for clinical practice decisions. Wheeler, ML., Franz, M., Barrier, P., et al.[2015]

The paper presents six alternative meal-planning approaches for individuals with diabetes, emphasizing the importance of personalized nutrition education beyond traditional exchange lists.

These approaches, including High Carbohydrate-High Fiber Exchange System and Calorie/Fat Counting, are evaluated based on their effectiveness for weight loss, glucose control, and ease of learning, providing a comprehensive resource for tailored dietary management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternatives to the exchange system for teaching meal planning to persons with diabetes. Pastors, JG.[2017]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

[A novel in-hospital meal service improves protein and energy intake]. [2018]

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

Prandial insulin dosing using the carbohydrate counting technique in hospitalized patients with type 2 diabetes. [2021]

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

Effects of a computerized order set on the inpatient management of hyperglycemia: a cluster-randomized controlled trial. [2022]

4. Japan pubmed.ncbi.nlm.nih.gov

Intervention with delivery of diabetic meals improves glycemic control in patients with type 2 diabetes mellitus. [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

Impact of electronic bedside meal ordering systems on dietary intake, patient satisfaction, plate waste and costs: A systematic literature review. [2020]

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

Computer-planned menus for patients with diabetes mellitus. [2019]

7. China pubmed.ncbi.nlm.nih.gov

Identifying errors in meals provided to and sourced by patients on therapeutic diets in hospital. [2019]

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

Monitor of tray error rates for quality control. [2000]

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

Exchange lists: revised 1986. [2009]

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

All Aboard Meal Train: Can Child-Friendly Menu Labeling Promote Healthier Choices in Hospitals? [2019]

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

Contextual factors are associated with diet quality in youth with type 1 diabetes mellitus. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Blood glucose and plasma insulin of mild diabetic patients in response to high protein divided meals. [2011]

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

Macronutrient and energy database for the 1995 Exchange Lists for Meal Planning: a rationale for clinical practice decisions. [2015]

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

Alternatives to the exchange system for teaching meal planning to persons with diabetes. [2017]