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Active Not Recruiting
NCT05441982
Saccharin and Acesulfame Potassium Consumption and Glucose Homeostasis in Older Adults With Prediabetes
Conditions: Continuous Glucose Monitoring, Oral Glucose Tolerance, Insulin Sensitivity, Inflammatory Markers
Sex: All
Ages: 40 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Virginia Polytechnic Institute and State University
Location: Virginia Tech Blacksburg Virginia
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 saccharin, but not acesulfame potassium, 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
* 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
Source: ClinicalTrials.gov (NCT05441982). StuddyBuddy aggregates publicly available trial information.