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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
Awards & highlights

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
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I am 40 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with inflammatory bowel disease.
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I have a history of heart, lung, hormone, blood, or cancer conditions.
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My blood pressure is not higher than 159/99 mmHg.
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I am currently using estrogen or testosterone.
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I have diabetes or am taking medication for it.
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I have not taken antibiotics or pre/probiotics in the last 3 months.
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I have food allergies or PKU.

Timeline

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

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,733 Previous Clinical Trials
28,054,952 Total Patients Enrolled
Virginia Polytechnic Institute and State UniversityLead Sponsor
149 Previous Clinical Trials
30,437 Total Patients Enrolled
1 Trials studying Continuous Glucose Monitoring
51 Patients Enrolled for Continuous Glucose Monitoring

Media Library

Acesulfame Potassium (Non-nutritive Sweetener) Clinical Trial Eligibility Overview. Trial Name: NCT05441982 — N/A
~27 spots leftby Dec 2025
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