Impact of Saccharin and Acesulfame-Potassium on Glycemia (NCT07506577) | Clinical Trial Compass
CompletedNot Applicable
Impact of Saccharin and Acesulfame-Potassium on Glycemia
United States14 participantsStarted 2022-07-30
Plain-language 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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Glucose tolerance
Timeframe: 120 minutes
Trial details
NCT IDNCT07506577
SponsorVirginia Polytechnic Institute and State University