Sweeteners for Prediabetes

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Purdue University

Must not be taking: Glucose metabolism drugs

Disqualifiers: Diabetes, Cardiovascular diseases, Metabolic disorders, others

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

Compensation: Varies

Number of Visits: 1

Duration: 10 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how different sweeteners affect blood sugar levels using a device that continuously monitors glucose. Participants will experience various taste stimulations, including no oral stimulation, water, salt, sucralose (a common artificial sweetener), and sucrose (table sugar), to observe each one's impact on blood sugar. The trial is designed for healthy adults without conditions like diabetes or heart disease and who are not on medications that could alter sugar metabolism or taste perception. As an unphased trial, it offers participants the opportunity to contribute to important research on sweeteners and blood sugar management.

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

You may need to stop taking medications that affect blood sugar or how you taste sweetness, but vitamins and contraceptives are okay if you keep taking them during the study.

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

Research has shown that sucralose is safe for people. Many studies have found that it does not affect blood sugar levels or cause harm. The FDA has also approved sucralose for children and people with diabetes, confirming its safety.

Regarding sucrose, studies have found no harmful effects when used for pain relief. No evidence suggests negative outcomes, even with repeated use. Sucrose is widely used, and safety reports consistently remain positive.

These findings suggest that both sucralose and sucrose are well-tolerated and safe for consumption. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential impact of different oral stimulations on prediabetes, a condition typically managed with lifestyle changes like diet and exercise, and sometimes medication. Unlike traditional approaches, this trial examines how various oral stimuli—like sucralose, sucrose, salt, and water—could influence prediabetic conditions. By focusing on the body's response to these oral stimuli, researchers hope to uncover novel insights into managing blood sugar levels without relying solely on dietary restrictions or medications. This unique approach could open new avenues for managing prediabetes by leveraging the sensory effects of everyday substances.

What evidence suggests that this trial's treatments could be effective for prediabetes?

This trial will compare different types of oral stimulation, including sucralose and sucrose, to understand their effects on prediabetes. Research has shown that sucralose, an artificial sweetener, can affect how the body handles blood sugar and insulin. Some studies suggest that sucralose might reduce insulin sensitivity, potentially impairing blood sugar management. However, other evidence indicates that sucralose can help lower blood sugar by prompting the body to release more insulin.

For sucrose, which is regular sugar, studies have shown it can quickly increase blood sugar levels because sucrose breaks down into glucose, which enters the bloodstream. People with prediabetes might experience a significant rise in blood sugar after consuming sucrose.

Both sucralose and sucrose affect blood sugar differently, which could influence prediabetes management. Participants in this trial will experience different types of oral stimulation, including sucralose and sucrose, to assess their impact on blood sugar management. ^{6 7 8 9 10}

Who Is on the Research Team?

Richard Mattes, PhD

Principal Investigator

Purdue University

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18 to 70 without diabetes, heart disease, metabolic disorders, or other chronic conditions affecting blood sugar. Participants should not have had major surgeries or be on medications that alter glucose metabolism or taste perception.

Inclusion Criteria

No dietary restrictions or sensitivities that prevent them from tasting or swishing sweeteners and rice cakes provided during the study

I am in good health without diabetes, heart disease, or other chronic conditions affecting blood sugar.

I haven't had major surgeries or procedures that could affect my blood sugar levels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants undergo taste testing with different sweeteners and continuous glucose monitoring

10 days

Home-based, self-administered

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• No Oral Stimulation
• Oral Salt Stimulation
• Oral Sucralose Stimulation
• Oral Sucrose Stimulation
• Oral Water Stimulation

Trial Overview The study tests how different sweeteners (sucralose and sucrose) and controls (salt, water, no stimulation) affect blood sugar levels using continuous glucose monitoring in people with prediabetes.

How Is the Trial Designed?

Group I: Oral Water Stimulation Experimental Treatment 1 Intervention

Oral stimulation with water.

Group II: Oral Sucrose stimulation Experimental Treatment 2 Interventions

Oral stimulation with sucrose.

Group III: Oral Sucralose Stimulation Experimental Treatment 1 Intervention

Oral stimulation with sucralose.

Group IV: Oral Salt Stimulation Experimental Treatment 1 Intervention

Oral stimulation with salt.

Group V: No Oral Stimulation Experimental Treatment 1 Intervention

No oral stimulation is provided.

Who Is Running the Clinical Trial?

Purdue University

Lead Sponsor

Trials

239

Recruited

72,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3747933/

Sucralose Affects Glycemic and Hormonal Responses to ... These data demonstrate that sucralose affects the glycemic and insulin responses to an oral glucose load in obese people who do not normally consume NNS.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0002916522029641

Sucralose decreases insulin sensitivity in healthy subjects Individuals assigned to sucralose consumption showed a significant decrease in insulin sensitivity with a median (IQR) percentage change of −17.7% (−29.3% to − ...

3. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(22)02966-5/fulltext

The not-so-sweet effects of sucralose on blood sugar control The key finding of the study was that sucralose consumption decreased insulin sensitivity by ∼18%, compared with a nonsignificant decrease in insulin ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10305118/

Long-Term Consumption of Sucralose Induces Hepatic Insulin ... These findings indicate that bolus administration of sucralose may stimulate insulin secretion, leading to a reduction in plasma glucose levels.

5. researchgate.net researchgate.net/publication/387443310_The_Impact_of_Sucralose_on_Blood_Glucose_Levels_in_Diabetic_Patients

(PDF) The Impact of Sucralose on Blood Glucose Levels in ... Conclusion Increased concentration of sucralose appears to decrease glucose uptake even on insulin stimulation. Clinical significance It may not be beneficial ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11233937/

Artificial sweeteners and their implications in diabetes: a review Numerous studies have examined the safety of sucralose, and their findings established the safety of this sweetener for human consumption (47).

7. sciencedirect.com sciencedirect.com/science/article/pii/S0273230017301265

A 12-week randomized clinical trial investigating the ... A 12-week clinical trial investigating the effects of sucralose on glycemic control. Sucralose had no effect on fasting or post-prandial glucose, insulin and C ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10971371/

Sucralose: From Sweet Success to Metabolic Controversies ... The FDA has also stated that sucralose is safe for consumption by children and individuals with diabetes [11]. The WHO has reported an ...

9. researchgate.net researchgate.net/publication/316863811_A_12-week_randomized_clinical_trial_investigating_the_potential_for_sucralose_to_affect_glucose_homeostasis

(PDF) A 12-week randomized clinical trial investigating the ... No statistically significant differences between sucralose and placebo groups in change from baseline for fasting glucose, insulin, C-peptide ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT04904133

Effects of Low/No Calorie Sweeteners on Glucose Tolerance This study aims to determine the effects of chronic exposure to some low/no calorie sweeteners (LNCS) on glucose tolerance and glucagon like peptide 1 (GLP-1) ...