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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 40 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
24-hour glycemic control
Secondary outcome measures
C-reactive protein
Insulin Sensitivity
Interleukin 6
+4 moreTrial 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
1,675 Previous Clinical Trials
28,020,874 Total Patients Enrolled
Virginia Polytechnic Institute and State UniversityLead Sponsor
142 Previous Clinical Trials
27,706 Total Patients Enrolled
1 Trials studying Continuous Glucose Monitoring
51 Patients Enrolled for Continuous Glucose Monitoring
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a body mass index (BMI) higher than 40.Your weight has stayed about the same for the past 6 months, give or take 2 kilograms.You consume less than one serving of artificial sweetener per week.You are not planning to change your weight or how much you exercise.I have a history of heart, lung, hormone, blood, or cancer conditions.I have been diagnosed with inflammatory bowel disease.My blood pressure is not higher than 159/99 mmHg.You have higher than normal blood sugar levels that could lead to diabetes.You are a vegetarian or vegan.I am currently using estrogen or testosterone.You do not engage in regular physical activity or exercise.I have diabetes or am taking medication for it.I have not taken antibiotics or pre/probiotics in the last 3 months.I have food allergies or PKU.You weigh less than 88 pounds for every 5 feet of height.I am 40 years old or older.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are enrollees currently being invited to take part in this investigation?
"As displayed on clinicaltrials.gov, this medical investigation is not presently recruiting patients. The trial was first made known to the public on February 1st 2023 and last updated August 5th 2022. Currently, there are 337 other studies actively seeking out individuals for participation."
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