Status:
RECRUITING
Non-Nutritive Sweetener Consumption and Glucose Homeostasis in Older Adults With Prediabetes
Lead Sponsor:
Virginia Polytechnic Institute and State University
Conditions:
Continuous Glucose Monitoring
Oral Glucose Tolerance
Eligibility:
All Genders
40+ years
Phase:
NA
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 m...
Detailed Description
Observational research has linked intake of non-nutritive sweeteners (NNS), which are consumed daily by \~50% of middle-aged/older U.S. adults, with increased risk of type 2 diabetes (T2D). This risk ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05337098
Start Date
April 18 2023
End Date
February 28 2026
Last Update
December 4 2025
Active Locations (1)
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1
Virginia Tech
Blacksburg, Virginia, United States, 24061