Impact of Saccharin and Acesulfame-Potassium on Glycemia

March 26, 2026 updated by: Valisa Hedrick, Virginia Polytechnic Institute and State University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Blacksburg, Virginia, United States, 24061
        • Virginia Tech

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 40+ years
  • Prediabetic
  • Weight stable for previous 6 months
  • BMI <40 kg/m2
  • Sedentary to recreationally active
  • No plans to gain/lose weight or change physical activity level
  • Consume less than one serving of non-sugar sweeteners per week

Exclusion Criteria:

  • Diabetes or any diabetes medications
  • Antibiotic, prebiotic or prebiotic use in prior 3 months
  • Blood pressure (BP) > 159/99 mmHg
  • Change in type or dose of these prescription medications over the past 6 months: antihypertensive medications, Statins, hormone replacement therapy (estrogen or testosterone) or oral contraceptives, thyroid medications
  • Diagnosed inflammatory bowel disease
  • Past or current heart diseases, stroke, respiratory disease, endocrine or metabolic disease, or hematological-oncological disease
  • Vegetarian or vegan
  • Pregnant or plans to become pregnant
  • Breastfeeding
  • Food allergies or aversions, Phenylketonuria (PKU)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: non-sugar sweetener - saccharin
Participants will receive 7.5 mg/kg of body weight of saccharin
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.
Other: non-sugar sweetener - acesulfame potassium
Participants will receive 7.5 mg/kg of body weight of acesulfame potassium
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.
Other: non-sugar sweetener - control
Participants will receive 240 mg of dextrose as the control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose tolerance
Time Frame: 120 minutes
assessment of glucose concentrations over a 120 minute period
120 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin
Time Frame: 120 minutes
assessment of insulin sensitivity over a 2 hour time period
120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Polytechnic Institute and State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2022

Primary Completion (Actual)

March 5, 2025

Study Completion (Actual)

May 1, 2025

Study Registration Dates

First Submitted

March 26, 2026

First Submitted That Met QC Criteria

March 26, 2026

First Posted (Actual)

April 1, 2026

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-559

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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