NCT05337098 · Virginia Polytechnic Institute and State University
Non-Nutritive Sweetener Consumption and Glucose Homeostasis in Older Adults With Prediabetes
What this study is about
Animal and observational research in humans suggest that specific types of non-nutritive sweeteners (NNS) may impair glycemic control. However, whether NNS consumption impacts glucose homeostasis in middle-aged/older adults with prediabetes is unknown, and potential mechanisms by which this could occur have yet to be identified.
View original scientific description
Animal and observational research in humans suggest that specific types of non-nutritive sweeteners (NNS) may impair glycemic control. However, whether NNS consumption impacts glucose homeostasis in middle-aged/older adults with prediabetes is unknown, and potential mechanisms by which this could occur have yet to be identified. The overall objective of this R21 proposal is to establish proof-of-concept for alterations in glucose homeostasis following intake of sucralose, but not aspartame, in middle-aged/older adults with prediabetes compared to a eucaloric diet with no NNS.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 40+ years
- Prediabetic (fasting glucose concentration of 100-125 mg/dL, 2-hour oral glucose tolerance test glucose concentration of 140-199 mg/dL, or a HbA1c value of 5.7% to 6.4%)
- Weight stable for previous 6 months (±2 kg)
- BMI \<40 kg/m2
- Sedentary to recreationally active
- No plans to gain/lose weight or change physical activity level
- Willing to pick up food daily and consume foods provided for an 8-week period
- Verbal and written informed consent
- Approval by Medical Director
- Consume less than one serving of non-nutritive sweetener per week
Exclusion criteria
- BMI \>40 kg/m2
- Diabetes or diabetes medication
- Antibiotic, prebiotic or prebiotic use in prior 3 months
- Uncontrolled hypertension (blood pressure (BP) \> 159/99 mmHg)
- Diagnosed inflammatory bowel disease
- Past or current heart diseases, stroke, respiratory disease, endocrine or metabolic disease, or hematological-oncological disease
- Vegetarian or vegan
- Pregnant or plans to become pregnant
- Breastfeeding
- Food allergies or aversions, Phenylketonuria (PKU)
- Estrogen or testosterone usage
Where
- Blacksburg, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 4, 2025 · Source of record for eligibility and locations