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Saccharin and Acesulfame Potassium Consumption and Glucose Homeostasis in Older Adults With Prediabetes

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Primary and study completion dates: Feb 28, 2026 to Nov 30, 2026
    • Trial status: Completed to Active, Not Recruiting
    v14
  2. Trial completed
    • Study completion moved earlier from Nov 28, 2026 to Feb 28, 2026
    v13
  3. Trial status changed: Recruiting → Active, Not Recruiting
    • Primary completion moved earlier from Nov 28, 2026 to Feb 28, 2026
    • Site details revised
    v12
  4. Primary and study completion dates: Dec 1, 2025 to Nov 28, 2026v11
  5. Enrollment target: 51 to 30
    • Primary and study completion dates: Nov 30, 2025 to Dec 1, 2025
    • Study description revised
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Re-verified, no change to tracked fieldsv9
  2. Primary and study completion dates: Dec 2025 to Nov 30, 2025v8
  3. Collaborators expanded, about 5 wordsv7
  4. Start date: Sep 1, 2023 to Sep 21, 2023v6
  5. Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Start date changed from estimate of Aug 1, 2023 to Sep 1, 2023
    • Eligibility criteria revised
    • Study description revised
    • Site details revised
  6. Start date: Feb 2023 to Aug 1, 2023v4
  7. Re-verified, no change to tracked fieldsv3
  8. Study Status, Eligibilityv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05441982
Lead Sponsor Virginia Polytechnic Institute and State University
Collaborators: National Institute on Aging (NIA)
Conditions
(from sponsor)		 Continuous Glucose Monitoring, Oral Glucose Tolerance, Insulin Sensitivity, Inflammatory Markers
Related terms Insulin Resistance
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov