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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

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Source: ClinicalTrials.gov (NCT05441982). StuddyBuddy aggregates publicly available trial information.