Slow Digestible Carbohydrates for Type 1 Diabetes

Overseen By Amanda House, RN,MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Disqualifiers: Severe hypoglycemia, Diabetic ketoacidosis, Chronic lung disease, others

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

Compensation: Varies

Number of Visits: 1

20 Participants Needed

Trial Summary

Do I have to stop taking 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 evidence supports the effectiveness of the treatment Maltodextrin, Maltodextrin powder, Dextrin, Maltodextrin DE, Super Starch for managing Type 1 Diabetes?

Research shows that resistant maltodextrin can lower blood sugar and insulin levels after meals in healthy people, which might help manage blood sugar in those with diabetes. Additionally, diets high in slowly digestible starch have been shown to improve blood sugar control in people with Type 2 Diabetes, suggesting potential benefits for Type 1 Diabetes as well. ^{1 2 3 4 5}

Is maltodextrin safe for human consumption?

Research indicates that maltodextrin is generally safe for human consumption, with no significant adverse effects on gastrointestinal symptoms reported in healthy adults. However, high doses may cause flatulence, and its rapid absorption can lead to increased blood sugar levels, which may be less desirable for health. ^{1 3 5 6 7}

How does the treatment of slow digestible carbohydrates differ from other treatments for type 1 diabetes?

Slow digestible carbohydrates, like the SUSTRA™ 2434 blend of tapioca flour and corn starch, provide a unique approach by releasing glucose slowly and steadily, which helps maintain balanced blood sugar levels over time. This is different from other treatments that may cause rapid spikes and drops in blood sugar, offering a more stable energy release and potentially improving glycemic control without adverse gastrointestinal effects. ^{3 8 9 10 11}

What is the purpose of this trial?

In this within-subject cross-over study, the investigators hypothesize that corn-starch based supplements taken prior to exercise will decrease the risk of delayed hypoglycemia in adolescents with T1D, improve performance during exercise, and decrease glycemic variability during exercise.

Research Team

Lucy Mastrandrea, MD, PhD

Principal Investigator

State University of New York at Buffalo

Eligibility Criteria

Adolescents aged 12-18 with Type 1 diabetes, who can exercise and have an HbA1c level below 10.5%. They must be within a healthy weight range and willing to wear a glucose monitor. Those with severe recent hypoglycemia, chronic lung or heart conditions, food allergies, or recent diabetic ketoacidosis cannot participate.

Inclusion Criteria

Your HbA1c level is less than 10.5%.

You are not using a special pump that helps manage your condition with added sensors.

I am between 12 and 17 years old and have had Type 1 diabetes for over a year.

Exclusion Criteria

I have a history of chronic lung or heart disease, or asthma.

I have had a severe low blood sugar episode needing help in the last 6 months.

You are allergic to food, including corn, or dyes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exercise Performance Test

Participants undergo a maximal exercise test to determine VO2max and complete two exercise performance tests with randomized carbohydrate consumption

1 day

1 visit (in-person)

Monitoring

Participants' glucose levels are monitored via continuous glucose monitoring for 12 hours after exercise

12 hours

Follow-up

Participants are monitored for safety and effectiveness after the exercise test

1-2 weeks

Treatment Details

Interventions

• Maltodextrin
• Super Starch

Trial Overview The study is testing if corn-starch based supplements (maltodextrin and super starch) taken before exercise can help prevent low blood sugar afterwards, improve workout performance, and stabilize blood sugar levels during physical activity in young people with Type 1 Diabetes.

Participant Groups

Group I: Fast Acting Carbohydrate Active Control 1 Intervention

Prior to exercise performance test, subject will be randomized to consume 22 grams of fast-acting carbohydrate (maltodextrin) or slow-acting cornstarch based supplement

Group II: Slow-acting cornstarch supplement Active Control 1 Intervention

Prior to exercise performance test, subject will be randomized to consume 22 grams of slow-acting cornstarch based supplement or fast-acting carbohydrate (maltodextrin)

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

Findings from Research

In a study involving 18 participants (12 with diabetes and 6 nondiabetic), hydrogenated starch hydrolysates (HSHs) produced a lower post-meal glycemic response compared to glucose, indicating they may be a better option for managing blood sugar levels.

Among the HSHs tested, HSH 6075 resulted in a higher glycemic response than HSH 5875, suggesting that the type of HSH can influence carbohydrate absorption and glycemic impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic response to oral challenge of hydrogenated starch hydrolysate versus glucose in diabetes. Wheeler, ML., Fineberg, SE., Gibson, R., et al.[2019]

The SUSTRA™ 2434 slowly digestible carbohydrate, made from tapioca flour and corn starch, showed a high slowly digestible fraction of 51% in vitro, indicating its potential for providing sustained energy.

In a study with 14 healthy adults, consuming foods containing this slowly digestible starch resulted in a lower glycemic index and a balanced release of energy, with lower blood glucose levels at 30-60 minutes and higher levels at 120-240 minutes post-consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Slowly Digestible Carbohydrate for Balanced Energy: In Vitro and In Vivo Evidence. Gourineni, V., Stewart, ML., Skorge, R., et al.[2018]

References

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

Metabolic response to oral challenge of hydrogenated starch hydrolysate versus glucose in diabetes. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Design and Validation of a Diet Rich in Slowly Digestible Starch for Type 2 Diabetic Patients for Significant Improvement in Glycemic Profile. [2022]

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

Slow Digestible Starch in Native Pea Starch (Pisum sativum L.) Lowers Glycemic Response with No Adverse Effects on Gastrointestinal Symptoms in Healthy Adults. [2023]

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

Complex carbohydrates in the prevention of nocturnal hypoglycaemia in diabetic children. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Attenuation of glycaemic and insulin responses following tapioca resistant maltodextrin consumption in healthy subjects: a randomised cross-over controlled trial. [2021]

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

Nutrition, Health, and Regulatory Aspects of Digestible Maltodextrins. [2022]

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

Consumption of the slow-digesting waxy maize starch leads to blunted plasma glucose and insulin response but does not influence energy expenditure or appetite in humans. [2021]

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

An Optimized, Slowly Digested Savory Cluster Reduced Postprandial Glucose and Insulin Responses in Healthy Human Subjects. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Glycemic Index of Slowly Digestible Carbohydrate Alone and in Powdered Drink-Mix. [2020]

10. Japan pubmed.ncbi.nlm.nih.gov

In Vivo Digestibility of Carbohydrate Rich in Isomaltomegalosaccharide Produced from Starch by Dextrin Dextranase. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Slowly Digestible Carbohydrate for Balanced Energy: In Vitro and In Vivo Evidence. [2018]