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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if corn-starch-based supplements can help teens with Type 1 Diabetes manage blood sugar more effectively during and after exercise. Researchers seek to discover whether these supplements reduce the risk of low blood sugar, enhance exercise performance, and stabilize blood sugar levels. Participants will compare the effects of a fast-acting carbohydrate (maltodextrin) and a slow-acting cornstarch supplement. Teens who have had Type 1 Diabetes for more than a year and are willing to wear a glucose monitor and participate in biking exercises may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve diabetes management for teens.

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.

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

Previous studies have shown that maltodextrin is safe for most people when consumed in small amounts. However, it can cause a quick rise in blood sugar, which might concern those with diabetes. Despite this, it is generally considered safe for use in foods.

Research on super starch, a type of slow-digesting starch, shows that it can help manage blood sugar levels by reducing sudden spikes. Studies suggest that it is well-tolerated and may offer health benefits like improving digestion and metabolism.

Both maltodextrin and super starch are used in many foods and are considered safe for general use. However, individual reactions can vary, so it is important to monitor how one feels when trying them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for managing blood sugar in type 1 diabetes, which often involves fast-acting carbohydrates like glucose tablets or regular meals, these treatments focus on the digestion speed of carbohydrates. Maltodextrin is a fast-acting carbohydrate that provides quick energy, while the slow-acting cornstarch supplement, known as Super Starch, is designed to release glucose gradually over time. Researchers are excited because the slow release from Super Starch could potentially help maintain stable blood sugar levels during exercise, reducing the risk of hypoglycemia. This approach could offer a new way to manage energy levels and blood sugar consistency for those with type 1 diabetes, especially during physical activity.

What evidence suggests that this trial's treatments could be effective for Type 1 Diabetes?

Research has shown that maltodextrin, which participants in this trial may receive, can help manage blood sugar levels by adjusting blood sugar and insulin responses, potentially benefiting exercise performance. Another treatment option in this trial is slow-acting cornstarch, such as Super Starch. Studies indicate that it can reduce the risk of low blood sugar, especially at night, for people with type 1 diabetes by slowly releasing sugar, helping to maintain steady blood sugar levels over time. Both treatments in this trial aim to enhance performance and minimize blood sugar fluctuations during exercise. ^{6 7 8 9 10}

Who Is on the Research Team?

Lucy Mastrandrea, MD, PhD

Principal Investigator

State University of New York at Buffalo

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12065221/

The effect of resistant dextrin on glucose regulation ... This systematic review and meta-analysis demonstrated that RD supplementation may effectively lower HbA1c levels in patients with T2D.

2. sdiopr.s3.ap-south-1.amazonaws.com sdiopr.s3.ap-south-1.amazonaws.com/2024/May/23-May-24/BJI_117498/Revised-ms_BJI_117498_v1.pdf

Part 1: Exploring the Metabolic Implications of Dextrin and ... Background: Dextrin and maltodextrin are dietary fibers with known benefits for modulating blood glucose levels and insulin responses.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9835112/

Validity of food additive maltodextrin as placebo and effects ... Maltodextrin (MDX) is a polysaccharide food additive commonly used as oral placebo/control to investigate treatments/interventions in humans.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0002916522106179

Galactomannans are the most effective soluble dietary ... Galactomannans were the most effective dietary fiber for reducing the levels of HbA1c, fasting blood glucose, triglycerides, and LDL cholesterol in patients ...

5. journalbji.com journalbji.com/index.php/BJI/article/view/722

Exploring the Metabolic Implications of Dextrin and ... The review confirms that resistant dextrin has positive impacts on insulin sensitivity and lipid metabolism, likely through the modulation of gut microbiota.

6. healthline.com healthline.com/health/food-nutrition/is-maltodextrin-bad-for-me

Is Maltodextrin Bad for Me? - Healthline Maltodextrin has a high glycemic index (GI) value, which means it can cause a spike in your blood sugar. It's safe to consume in very small amounts.

7. medicalnewstoday.com medicalnewstoday.com/articles/322426

What is Maltodextrin? Dangers, subsitutes, and more Experts consider it to be safe for the majority of people, although it may also carry some risks, particularly for people with diabetes. People may prefer to ...

8. webmd.com webmd.com/diet/what-is-maltodextrin

What Is Maltodextrin? The glycemic index (GI) of maltodextrin is higher than that of table sugar. This means that the powder can cause a spike in your blood sugar ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4940893/

Nutrition, Health, and Regulatory Aspects of Digestible ... The resulting commercially available, mostly white, powders are of high purity and microbiological safety and are used in a wide range of food and beverage ...

10. fda.gov fda.gov/files/food/published/GRAS-Notice-000610---Isomaltodextrin.pdf

GRAS Notice 610: Isomaltodextrin Hayashibara Co., Ltd. (Hayashibara) has determined that IMD is generally recognized as safe (GRAS) based on scientific procedures under 21 ...