NCT05337098 Non-Nutritive Sweetener Consumption and Glucose Homeostasis in Older Adults With Prediabetes
| NCT ID | NCT05337098 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Virginia Polytechnic Institute and State University |
| Condition | Continuous Glucose Monitoring |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-04-18 |
| Primary Completion | 2026-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2023-04-18 with a primary completion date of 2026-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Valisa Hedrick, PhD
PRINCIPAL INVESTIGATOR
Virginia Polytechnic Institute and State University
Frequently Asked Questions
Who can join the NCT05337098 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Continuous Glucose Monitoring. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05337098 currently recruiting?
Yes, NCT05337098 is actively recruiting participants. Contact the research team at vhedrick@vt.edu for enrollment information.
Where is the NCT05337098 trial being conducted?
This trial is being conducted at Blacksburg, United States.
Who is sponsoring the NCT05337098 clinical trial?
NCT05337098 is sponsored by Virginia Polytechnic Institute and State University. The principal investigator is Valisa Hedrick, PhD at Virginia Polytechnic Institute and State University. The trial plans to enroll 30 participants.