Continuous Glucose MonitoringNCT05441982
Saccharin and Acesulfame Potassium Consumption and Glucose Homeostasis in Older Adults With Prediabetes
A study testing Non-Nutritive Sweetener Intake and impact on glucose homeostasis in people with Continuous Glucose Monitoring and Oral Glucose Tolerance, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial summary
Animal and observational research in humans suggest that specific types of non-nutritive sweeteners (NNS) may impair glycemic control. However, whether NNS consumption impacts glucose homeostasis in middle-aged/older adults with prediabetes is unknown, and potential mechanisms by which this could occur have yet to be… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Continuous Glucose Monitoring, Oral Glucose Tolerance, Insulin Sensitivity
- What is being tested?
- Non-Nutritive Sweetener Intake and impact on glucose homeostasis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2023to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 (fasting glucose concentration of 100-125 mg/dL, 2-hour oral glucose tolerance test glucose concentration of 140-199 mg/dL, or a HbA1c value of 5.7% to 6.4%)
- Weight stable for previous 6 months (±2 kg)
- BMI <40 kg/m2
- Sedentary to recreationally active
- No plans to gain/lose weight or change physical activity level
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- Willing to pick up food daily and consume foods provided for an 8-week period
- Verbal and written informed consent
- Approval by Medical Director
- Consume less than one serving of non-nutritive sweetener per week
Who cannot join
- BMI >40 kg/m2
- Diabetes or diabetes medication
- Antibiotic, prebiotic or prebiotic use in prior 3 months
- Uncontrolled hypertension (blood pressure (BP) > 159/99 mmHg)
- Diagnosed inflammatory bowel disease
- Past or current heart diseases, stroke, respiratory disease, endocrine or metabolic disease, or hematological-oncological disease
Show all 11Show fewer
- Vegetarian or vegan
- Pregnant or plans to become pregnant
- Breastfeeding
- Food allergies or aversions, Phenylketonuria (PKU)
- Estrogen or testosterone usage
Trial locations and contacts
1 site in 1 country.
About this study
Animal and observational research in humans suggest that specific types of non-nutritive sweeteners (NNS) may impair glycemic control. However, whether NNS consumption impacts glucose homeostasis in middle-aged/older adults with prediabetes is unknown, and potential mechanisms by which this could occur have yet to be identified. The overall objective of this R21 proposal is to establish proof-of-concept for alterations in glucose homeostasis following intake of saccharin, but not acesulfame potassium, in middle-aged/older adults with prediabetes compared to a eucaloric diet with no NNS.
Read the detailed description
Observational research has linked intake of non-nutritive sweeteners (NNS), which are consumed daily by ~50% of middle-aged/older U.S. adults, with increased risk of type 2 diabetes (T2D). This risk may be exacerbated by advancing age, which is associated with low-grade chronic inflammation and increased risk of T2D. Current T2D prevention recommendations related to NNS usage are unclear and confusing; use as an alternative to added sugar intake is suggested but long-term NNS use is discouraged despite minimal research to support this recommendation. Animal and observational human studies suggest detrimental effects of some NNS on glucose homeostasis. Longer-term human studies largely demonstrate null findings. Differences in study design and a lack of rigor in existing research contribute to inconclusive findings. In addition, NNS are often studied as a single entity yet types of NNS vary in their absorption and metabolism (e.g., two commonly consumed NNS, saccharin and acesulfame potassium). Whether NNS consumption impacts glucose homeostasis in middle-aged/older adults with prediabetes is unknown, and potential mechanisms by which this could occur have yet to be identified. The overall objective of this R21 proposal is to establish proof-of-concept for alterations in glucose homeostasis following intake of saccharin, but not acesulfame potassium, in middle-aged/older adults with prediabetes compared to a eucaloric diet with no NNS. We will investigate changes in inflammatory markers as potential mechanisms by which saccharin intake influences glucose homeostasis. Following a 2-week eucaloric lead-in diet, 30 middle-aged/older adults (40+ yrs) with prediabetes will be randomly assigned to 1 of 3 controlled feeding conditions for 6 weeks (10 participants per group): saccharin, acesulfame potassium, or a control group (no NNS). Standardized diets will be matched for macronutrients (50% carbohydrate, 35% fat, 15% protein) and other variables to avoid the potential confounds of weight change and dietary factors which may influence study outcomes (e.g., added sugars). All groups will receive identical diets, other than the additional NNS for the two NNS groups. 24-hr glycemic control using continuous glucose monitoring and insulin sensitivity and beta cell function via oral glucose tolerance test (OGTT), serum endotoxin, and inflammatory cytokines, including C-reactive protein, will be measured before and following the 6-week dietary treatment period. This research may have clinical practice and policy implications by informing U.S. dietary guidelines and guidelines for T2D prevention, which devote minimal attention to NNS and provide unclear guidance on NNS use due largely to a lack of rigorously-designed controlled feeding trials.
- Conditions
- Continuous Glucose Monitoring, Oral Glucose Tolerance, Insulin Sensitivity, Inflammatory Markers
- Being tested
- Non-Nutritive Sweetener Intake and impact on glucose homeostasis
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Nutritive Sweetener Intake and impact on glucose homeostasisOther
Provision of either saccharin, acesulfame potassium, or control with no non-nutritive sweeteners to a controlled feeding study to determine impacts on glucose homeostasis.
| Study group | Role | What they receive |
|---|---|---|
| Acesulfame Potassium | Active comparator | Controlled feeding study. Dosage of acesulfame potassium will follow 25% of the acceptable daily intake (equivalent to 3.75 mg/kg). This amount represents 225 mg/day of acesulfame potassium for a 60 kg adult. Receives: Other: Non-Nutritive Sweetener Intake and impact on glucose homeostasis |
| Saccharin | Active comparator | Controlled feeding study. Dosage of saccharin will follow 25% of the acceptable daily intake (equivalent to 3.75 mg/kg). This amount represents 225 mg/day of saccharin for a 60 kg adult. Receives: Other: Non-Nutritive Sweetener Intake and impact on glucose homeostasis |
| No NNS | Placebo comparator | controlled feeding study with no non-nutritive sweeteners Receives: Other: Non-Nutritive Sweetener Intake and impact on glucose homeostasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour glycemic control
The area under the curve (AUC) glucose concentrations, mg/dl from the continuous glucose monitoring at baseline and follow-up will be used
Measured: 6 weeks
Secondary outcomes (7)
Oral glucose tolerance
Oral glucose tolerance in response to 75 g glucose load; levels of glucose mg/dl will be determined 2 hrs after consuming a 75 glucose load
Measured: 6 weeks
Insulin Sensitivity
Insulin uU/mL concentrations from the oral glucose tolerance test at baseline and follow-up will be used
Measured: 6 weeks
Serum Endotoxin
Serum endotoxin mg/L concentrations will be measured at baseline and follow-up
Measured: 6 weeks
C-reactive protein
C-reactive protein mg/dL concentrations will be measured at baseline and follow-up
Measured: 6 weeks
Tumor Necrosis Factor alpha
Inflammatory cytokine: Tumor Necrosis Factor alpha pg/mL concentrations will be measured at baseline and follow-up
Measured: 6 weeks
Interleukin 6
Inflammatory cytokine: Interleukin 6 pg/mL concentrations will be measured at baseline and follow-up
Measured: 6 weeks
Monocyte chemoattractant protein-1
Inflammatory cytokine: Monocyte chemoattractant protein-1 pg/mL concentrations will be measured at baseline and follow-up
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start21 Sep 2023
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuous Glucose MonitoringStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441982
- Sponsor's protocol ID
- 1R21AG080358-01
- Status last verified
- Jun 2026
- First submitted
- 28 Jun 2022
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified study data will be posted to Virginia Tech's data repository, VTechData (https:// data.lib.vt.edu/). Datasets selected for sharing will be made accessible through VTechData, managed by the University Libraries at Virginia Tech. VTechData highlights, preserves, and provides access to data generated at Virginia Tech. The system relies on item/dataset level metadata as the primary building block to data discovery, access, and reuse. Published datasets are to be made accessible for at least five years.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saccharin and Acesulfame Potassium Consumption and Glucose Homeostasis in Older Adults With Prediabetes
- ClinicalTrials.gov ID
- NCT05441982
- Acronym / sponsor ID
- 1R21AG080358-01
- Conditions
- Continuous Glucose Monitoring, Oral Glucose Tolerance, Insulin Sensitivity, Inflammatory Markers
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 1 Jul 2022 (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.
Animal and observational research in humans suggest that specific types of non-nutritive sweeteners (NNS) may impair glycemic control. However, whether NNS consumption impacts glucose homeostasis in middle-aged/older adults with prediabetes is unknown, and potential mechanisms by which this could occur have yet to be identified. The overall objective of this R21 proposal is to establish proof-of-concept for alterations in glucose homeostasis following intake of saccharin, but not acesulfame potassium, in middle-aged/older adults with prediabetes compared to a eucaloric diet with no NNS.
Detailed description
Observational research has linked intake of non-nutritive sweeteners (NNS), which are consumed daily by ~50% of middle-aged/older U.S. adults, with increased risk of type 2 diabetes (T2D). This risk may be exacerbated by advancing age, which is associated with low-grade chronic inflammation and increased risk of T2D. Current T2D prevention recommendations related to NNS usage are unclear and confusing; use as an alternative to added sugar intake is suggested but long-term NNS use is discouraged despite minimal research to support this recommendation. Animal and observational human studies suggest detrimental effects of some NNS on glucose homeostasis. Longer-term human studies largely demonstrate null findings. Differences in study design and a lack of rigor in existing research contribute to inconclusive findings. In addition, NNS are often studied as a single entity yet types of NNS vary in their absorption and metabolism (e.g., two commonly consumed NNS, saccharin and acesulfame potassium). Whether NNS consumption impacts glucose homeostasis in middle-aged/older adults with prediabetes is unknown, and potential mechanisms by which this could occur have yet to be identified. The overall objective of this R21 proposal is to establish proof-of-concept for alterations in glucose homeostasis following intake of saccharin, but not acesulfame potassium, in middle-aged/older adults with prediabetes compared to a eucaloric diet with no NNS. We will investigate changes in inflammatory markers as potential mechanisms by which saccharin intake influences glucose homeostasis. Following a 2-week eucaloric lead-in diet, 30 middle-aged/older adults (40+ yrs) with prediabetes will be randomly assigned to 1 of 3 controlled feeding conditions for 6 weeks (10 participants per group): saccharin, acesulfame potassium, or a control group (no NNS). Standardized diets will be matched for macronutrients (50% carbohydrate, 35% fat, 15% protein) and other variables to avoid the potential confounds of weight change and dietary factors which may influence study outcomes (e.g., added sugars). All groups will receive identical diets, other than the additional NNS for the two NNS groups. 24-hr glycemic control using continuous glucose monitoring and insulin sensitivity and beta cell function via oral glucose tolerance test (OGTT), serum endotoxin, and inflammatory cytokines, including C-reactive protein, will be measured before and following the 6-week dietary treatment period. This research may have clinical practice and policy implications by informing U.S. dietary guidelines and guidelines for T2D prevention, which devote minimal attention to NNS and provide unclear guidance on NNS use due largely to a lack of rigorously-designed controlled feeding trials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acesulfame Potassium | Active comparator | Other: Non-Nutritive Sweetener Intake and impact on glucose homeostasisControlled feeding study. Dosage of acesulfame potassium will follow 25% of the acceptable daily intake (equivalent to 3.75 mg/kg). This amount represents 225 mg/day of acesulfame potassium for a 60 kg adult. |
| Saccharin | Active comparator | Other: Non-Nutritive Sweetener Intake and impact on glucose homeostasisControlled feeding study. Dosage of saccharin will follow 25% of the acceptable daily intake (equivalent to 3.75 mg/kg). This amount represents 225 mg/day of saccharin for a 60 kg adult. |
| No NNS | Placebo comparator | Other: Non-Nutritive Sweetener Intake and impact on glucose homeostasiscontrolled feeding study with no non-nutritive sweeteners |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 40+ years
- Prediabetic (fasting glucose concentration of 100-125 mg/dL, 2-hour oral glucose tolerance test glucose concentration of 140-199 mg/dL, or a HbA1c value of 5.7% to 6.4%)
- Weight stable for previous 6 months (±2 kg)
- BMI <40 kg/m2
- Sedentary to recreationally active
Key exclusion criteria (11 listed)
- BMI >40 kg/m2
- Diabetes or diabetes medication
- Antibiotic, prebiotic or prebiotic use in prior 3 months
- Uncontrolled hypertension (blood pressure (BP) > 159/99 mmHg)
- 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-Nutritive Sweetener Intake and impact on glucose homeostasisProvision of either saccharin, acesulfame potassium, or control with no non-nutritive sweeteners to a controlled feeding study to determine impacts on glucose homeostasis. | Other | Acesulfame Potassium, No NNS, Saccharin |
Primary outcome
24-hour glycemic control
Time frame: 6 weeks
The area under the curve (AUC) glucose concentrations, mg/dl from the continuous glucose monitoring at baseline and follow-up will be used
7 secondary outcomes
Oral glucose tolerance
Time frame: 6 weeks
Insulin Sensitivity
Time frame: 6 weeks
Serum Endotoxin
Time frame: 6 weeks
C-reactive protein
Time frame: 6 weeks
Tumor Necrosis Factor alpha
Time frame: 6 weeks
Interleukin 6
Time frame: 6 weeks
Monocyte chemoattractant protein-1
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified study data will be posted to Virginia Tech's data repository, VTechData (https:// data.lib.vt.edu/). Datasets selected for sharing will be made accessible through VTechData, managed by the University Libraries at Virginia Tech. VTechData highlights, preserves, and provides access to data generated at Virginia Tech. The system relies on item/dataset level metadata as the primary building block to data discovery, access, and reuse. Published datasets are to be made accessible for at least five years.
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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-Nutritive Sweetener Intake and impact on glucose homeostasis in people with Continuous Glucose Monitoring and Oral Glucose Tolerance, 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 10 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 10 Jun 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?
This study is still under way. Results are not available in the source record yet.
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?
24-hour glycemic control (time frame: 6 weeks). 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 10 Jun 2026.