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

Part of paid clinical trials in Blacksburg, Virginia.

Sponsor
Virginia Polytechnic Institute and State University
Study ID
NCT05337098
Status
Recruiting
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Conditions

  • Continuous Glucose Monitoring
  • Inflammatory Markers
  • Insulin Sensitivity
  • Oral Glucose Tolerance

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Non-Nutritive Sweetener Intake and impact on glucose homeostasis — OTHER
    Provision of either aspartame, sucralose, or control with no non-nutritive sweeteners to a controlled feeding study to determine impacts on glucose homeostasis.

Study Details

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.

Key Dates

Start date
Apr 18, 2023
Status verified
Dec 2025
Primary completion
Feb 28, 2026
Completion
Feb 28, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Aspartame
    Controlled feeding study. Dosage of aspartame will follow 25% of the acceptable daily intake (equivalent to 12.5 mg/kg for aspartame). This amount represents 750 mg/day of aspartame for a 60 kg adult.
  • Active Comparator: Sucralose
    Controlled feeding study. Dosage of sucralose will follow 25% of the acceptable daily intake (equivalent to 1.25 mg/kg for sucralose). This amount represents 75 mg/day of sucralose for a 60 kg adult.
  • Sham Comparator: No NNS
    Controlled feeding study with no non-nutritive sweeteners.

Primary Outcome Measure

24-hour glycemic control [ Time Frame: 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia TechBlacksburgVirginia24061
Valisa Hedrick, PhD

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Virginia Tech· Blacksburg, VA

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