NCT07506577

Impact of Saccharin and Acesulfame-Potassium on Glycemia

Acute Impact of Saccharin and Acesulfame-Potassium Consumption and Glucose Levels in Middle-Aged and Older Adults With Prediabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Virginia Polytechnic Institute and State University · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study will utilize a randomized 3 period crossover design, with 3 instances of controlled feeding. The overall objective of this study is to establish proof-of-concept for impaired glycemic control and insulin sensitivity, but no alterations following aspartame intake, in middle-aged/older adults with prediabetes. We aim to enroll 14 middle-aged/older adults (40+ years) with prediabetes. Participants will be randomly assigned to 1 of 3 controlled feeding conditions for 3 separate visits: acesulfame-potassium, saccharin, or control, each separated by a week. All participants will have been assigned to each artificial sweetener once by the end of the study. All test conditions will receive an identical breakfast, with the exception of the sweetener type. Glucose tolerance and insulin sensitivity will be measured directly after each controlled feeding.

Conditions

• Prediabetes

Interventions

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

Timeline

• Start date: 2022-07-30
• Primary completion: 2025-03-05
• Completion: 2025-05-01
• First posted: 2026-04-01
• Last updated: 2026-04-01

Locations

1 site across 1 country: United States