Impact of Saccharin and Acesulfame-Potassium on Glycemia

Part of paid clinical trials in Blacksburg, Virginia.

Sponsor
Virginia Polytechnic Institute and State University
Study ID
NCT07506577
Status
Completed

Conditions

  • Prediabetes

Eligibility Criteria

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

Interventions

  • non-sugar sweetener - saccharin — OTHER
    Participants will receive 7.5 mg/kg of body weight of saccharin
  • non-sugar sweetener - acesulfame potassium — OTHER
    Participants will receive 7.5 mg/kg of body weight of acesulfame potassium
  • non-sugar sweetener - control — OTHER
    Participants will receive 240 mg of dextrose as the control.

Study Details

The major purpose of this research project is to learn if consuming artificial sweeteners have any impact on glucose levels in adults at high risk for developing type 2 diabetes. People may be at risk for diabetes if you are a middle-aged or older adult. Briefly, the full study is 3 weeks long with 3 controlled feeding visits. Which means participants will eat all of the food and drinks that we provide to them for breakfast. Participants will come to the lab in the morning to eat breakfast, and we will monitor changes in blood glucose over a 2 hour period. Participants will be randomized into 1 of 3 groups: 1 group will receive acesulfame-potassium, 1 group will receive saccharin, and 1 group will receive no artificial sweeteners. Participants will experience a different group each visit, with about 7 days between each visit. We will be examining if consuming artificial sweeteners has any impact on glucose levels.

Key Dates

Start date
Jul 30, 2022
Status verified
Mar 2026
Primary completion
Mar 5, 2025
Completion
May 1, 2025

Study Design

Enrollment
14 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Active Comparator: non-sugar sweetener - saccharin
    Controlled feeding: Participants will be provided a standardized breakfast, a beverage containing their respective sweetener, and capsules containing the same sweetener. For the saccharin arm, participants receive 50% of the ADI (7.5 mg/kg). Blood glucose and insulin will be measured at 0 minutes and every 30 minutes for 120 minutes post breakfast.
  • Active Comparator: non-sugar sweetener - acesulfame potassium
    Controlled feeding: Participants will be provided a standardized breakfast, a beverage containing their respective sweetener, and capsules containing the same sweetener. For the acesulfame-potassium arm, participants receive 50% of the ADI (7.5 mg/kg). Blood glucose and insulin will be measured at 0 minutes and every 30 minutes for 120 minutes post breakfast.
  • Placebo Comparator: non-sugar sweetener - control
    Controlled feeding: Participants will be provided a standardized breakfast, a beverage containing no non-sugar sweetener, and capsules containing dextrose. Blood glucose and insulin will be measured at 0 minutes and every 30 minutes for 120 minutes post breakfast.

Primary Outcome Measure

Glucose tolerance [ Time Frame: 120 minutes ]

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia TechBlacksburgVirginia24061-

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