PrediabetesNCT07506577
Impact of Saccharin and Acesulfame-Potassium on Glycemia
A study testing non-sugar sweetener - saccharin and non-sugar sweetener - acesulfame potassium in people with Prediabetes, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Prediabetes
- What is being tested?
- non-sugar sweetener - saccharin and non-sugar sweetener - acesulfame potassium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2022to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Vegetarian or vegan
- Pregnant or plans to become pregnant
- Breastfeeding
- Food allergies or aversions, Phenylketonuria (PKU)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- non-sugar sweetener - saccharin, non-sugar sweetener - acesulfame potassium, non-sugar sweetener - control
- Keywords
- non-sugar sweeteners, glucose
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-sugar sweetener - saccharinOther
Participants will receive 7.5 mg/kg of body weight of saccharin
non-sugar sweetener - acesulfame potassiumOther
Participants will receive 7.5 mg/kg of body weight of acesulfame potassium
non-sugar sweetener - controlOther
Participants will receive 240 mg of dextrose as the control.
| Study group | Role | What they receive |
|---|---|---|
| non-sugar sweetener - saccharin | Active comparator | 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. Receives: Other: non-sugar sweetener - saccharin |
| non-sugar sweetener - acesulfame potassium | Active comparator | 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. Receives: Other: non-sugar sweetener - acesulfame potassium |
| non-sugar sweetener - control | Placebo comparator | 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. Receives: Other: non-sugar sweetener - control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose tolerance
assessment of glucose concentrations over a 120 minute period
Measured: 120 minutes
Secondary outcomes (1)
Insulin
assessment of insulin sensitivity over a 2 hour time period
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start30 Jul 2022
- Primary completion5 Mar 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valisa Hedrick, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506577
- Sponsor's protocol ID
- 22-559
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Impact of Saccharin and Acesulfame-Potassium Consumption and Glucose Levels in Middle-Aged and Older Adults With Prediabetes
- ClinicalTrials.gov ID
- NCT07506577
- Acronym / sponsor ID
- 22-559
- Conditions
- Prediabetes
- Keywords
- non-sugar sweeteners, glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- 30 Jul 2022 (actual)
- Primary completion
- 5 Mar 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| non-sugar sweetener - saccharin | Active comparator | Other: non-sugar sweetener - saccharinControlled 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. |
| non-sugar sweetener - acesulfame potassium | Active comparator | Other: non-sugar sweetener - acesulfame potassiumControlled 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. |
| non-sugar sweetener - control | Placebo comparator | Other: non-sugar sweetener - controlControlled 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 40+ years
- Prediabetic
- Weight stable for previous 6 months
- BMI <40 kg/m2
- Sedentary to recreationally active
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-sugar sweetener - saccharinParticipants will receive 7.5 mg/kg of body weight of saccharin | Other | non-sugar sweetener - saccharin |
| non-sugar sweetener - acesulfame potassiumParticipants will receive 7.5 mg/kg of body weight of acesulfame potassium | Other | non-sugar sweetener - acesulfame potassium |
| non-sugar sweetener - controlParticipants will receive 240 mg of dextrose as the control. | Other | non-sugar sweetener - control |
Primary outcome
Glucose tolerance
Time frame: 120 minutes
assessment of glucose concentrations over a 120 minute period
1 secondary outcome
Insulin
Time frame: 120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-sugar sweetener - saccharin and non-sugar sweetener - acesulfame potassium in people with Prediabetes, run by Virginia Polytechnic Institute and State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose tolerance (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.