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Non-Nutritive Sweetener Consumption and Glucose Homeostasis in Older Adults With Prediabetes

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Primary endpoint(s) modified Show 7 more changesShow less
    • Results posted: Sep 24, 2026
    • Trial completed
    • Enrollment target: estimated 30 to confirmed 31
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints shortened, about 18 words
    • Study description revised
    • Site details revised
  2. Primary completion date: Nov 1, 2025 to Feb 28, 2026v10
  3. Enrollment target: 51 to 30
    • Eligibility criteria revised
    • Study description revised
    v9
  4. Primary completion date: Feb 28, 2025 to Nov 1, 2025
    • Study completion date: Feb 28, 2025 to Feb 28, 2026
    v8
  5. Primary and study completion dates: Feb 29, 2024 to Feb 28, 2025
    • Start date: Jan 16, 2023 to Apr 18, 2023
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Start date: Jan 15, 2023 to Jan 16, 2023v6
  2. Re-verified, no change to tracked fieldsv5
  3. Start date: Aug 1, 2022 to Jan 15, 2023v4
  4. Start date: Jul 1, 2022 to Aug 1, 2022v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jun 1, 2022 to Jul 1, 2022
    • Study sites: 0 to 1
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 sucralose, but not aspartame, in middle-aged/older adults with prediabetes compared to a eucaloric diet with no NNS.
Trial Details
NCT Number NCT05337098
Lead Sponsor Virginia Polytechnic Institute and State University
Conditions
(from sponsor)		 Continuous Glucose Monitoring, Oral Glucose Tolerance, Insulin Sensitivity, Inflammatory Markers
Related terms Insulin Resistance
Enrollment 31 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov