← Back to Search

Non-nutritive Sweetener

Non-Nutritive Sweeteners for Prediabetes

N/A

Recruiting

Research Sponsored by Virginia Polytechnic Institute and State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 40+ years

Be older than 18 years old

Must not have

Diagnosed inflammatory bowel disease

Past or current heart diseases, stroke, respiratory disease, endocrine or metabolic disease, or hematological-oncological disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Summary

This trial will test if saccharin, but not acesulfame potassium, impacts glucose homeostasis in middle-aged/older adults with prediabetes compared to a eucaloric diet with no NNS.

Who is the study for?

This trial is for middle-aged and older adults over 40 with prediabetes, who have been weight stable and are not on a special diet or planning to change their physical activity. They should be non-vegetarians without serious health conditions like heart disease or diabetes, not pregnant, and consume less than one serving of artificial sweeteners per week.

What is being tested?

The study tests the effects of two artificial sweeteners, saccharin and acesulfame potassium, on blood sugar control in people with prediabetes. Participants will follow a specific diet including these sweeteners to see if there's any difference in how their bodies handle glucose compared to a normal diet without these sweeteners.

What are the potential side effects?

While the trial itself does not list side effects, common concerns about non-nutritive sweetener intake include potential impacts on metabolism, appetite regulation, and possibly altering gut bacteria which could affect digestion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 40 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with inflammatory bowel disease.

Select...

I have a history of heart, lung, hormone, blood, or cancer conditions.

Select...

My blood pressure is not higher than 159/99 mmHg.

Select...

I am currently using estrogen or testosterone.

Select...

I have diabetes or am taking medication for it.

Select...

I have not taken antibiotics or pre/probiotics in the last 3 months.

Select...

I have food allergies or PKU.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

24-hour glycemic control

Secondary study objectives

C-reactive protein

Insulin Sensitivity

Interleukin 6

+4 more

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Acesulfame PotassiumActive Control1 Intervention

Controlled feeding study. Dosage of acesulfame potassium will follow 25% of the acceptable daily intake (equivalent to 3.75 mg/kg). This amount represents 225 mg/day of acesulfame potassium for a 60 kg adult.

Group II: SaccharinActive Control1 Intervention

Controlled feeding study. Dosage of saccharin will follow 25% of the acceptable daily intake (equivalent to 3.75 mg/kg). This amount represents 225 mg/day of saccharin for a 60 kg adult.

Group III: No NNSPlacebo Group1 Intervention

controlled feeding study with no non-nutritive sweeteners

0 / 8Eligibility criteria met