Acute Impact of Non-Sugar Sweeteners (Sucralose and Aspartame)

Part of paid clinical trials in Blacksburg, Virginia.

Sponsor
Virginia Polytechnic Institute and State University
Study ID
NCT07506564
Status
Completed

Conditions

  • Prediabetes

Eligibility Criteria

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

Interventions

  • non-sugar sweeteners - Sucralose — OTHER
    Participants will be given 2.5 mg/kg of body weight of sucralose
  • non-sugar sweetener - aspartame — OTHER
    Participants will receive 25 mg/kg body weight of aspartame
  • Non-sugar sweetener - control — OTHER
    Participants will receive 340 mg of dextrose

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 aspartame (Equal), 1 group will receive sucralose (Splenda), 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
Aug 1, 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: Sucralose Arm
    Controlled feeding: Participants will be provided a standardized breakfast, a beverage containing their respective sweetener, and capsules containing the same sweetener. For the sucralose arm, participants receive 50% of the ADI (2.5 mg/kg). Blood glucose and insulin will be measured at 0 minutes and every 30 minutes for 120 minutes post breakfast.
  • Active Comparator: Aspartame Arm
    Controlled feeding: Participants will be provided a standardized breakfast, a beverage containing their respective sweetener, and capsules containing the same sweetener. For the aspartame arm, participants receive 50% of the ADI (25 mg/kg). Blood glucose and insulin will be measured at 0 minutes and every 30 minutes for 120 minutes post breakfast.
  • Placebo Comparator: Control Arm
    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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