Non-Nutritive SweetenerNCT07434544
Cardiometabolic Effects of Non-Nutritive Sweeteners (NNS) in Type 1 Diabetes (T1D)
A study testing Cherry Sports Drink in people with Non-Nutritive Sweetener and Type 1 Diabetes, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This project will apply a novel non-nutritive sweetener (NNS) dietary assessment tool with measurement of circulating NNS levels in a pediatric population, allowing correlation of NNS exposure to clinically meaningful cardiometabolic health outcomes. Read more about this study
- Who is it for?
- Ages 15 to 24 years
- Conditions the study is for
- Non-Nutritive Sweetener, Type 1 Diabetes, type1diabetes
- What is being tested?
- Cherry Sports Drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2026to 31 Dec 2029
- Phase
- Interventional
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 15 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 15-24 years
- Clinical diagnosis of type 1 diabetes, requiring insulin therapy, of ≥ 1 to < 10 years duration.
- Last available HbA1c ≤ 8.5% (obtained by chart review in Children's Wisconsin Diabetes Clinic patients or verbally by individuals not receiving diabetes care at Children's Wisconsin)
- Current use of an FDA approved automated insulin delivery (AID) system
- Willing to consume a 12 ounce Gatorade G Zero Glacier Cherry drink in less than 10 minutes
- Willing and able to give informed consent or have parent or legal guardian provide informed consent if the subject is < 18 years of age
Who cannot join
- Any disease other than type 1 diabetes that affects glucose, sex steroid, or fat metabolism such as polycystic ovary syndrome or hypercortisolism
- Any medication use that may affect glucose, sex steroid, or fat metabolism such as metformin or glucocorticoids
- Half or full sibling already participating in this study
- Known cardiovascular disease such as hypertension or atherosclerosis, and/or use of an anti-hypertensive medication
- Known hyperlipidemia, defined as LDL ≥ 160 mg/dL, and/or use of lipid-lowering medication, such as statin therapy
- Known renal disease or microalbuminuria, and/or use of angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blockers (ARBs) for microalbuminuria
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- Known diabetic retinopathy or neuropathy
- Raynaud's phenomenon or other vascular disease
- Obesity and/or body habitus that precludes completion of the flow-mediated brachial ultrasound study (generally, BMI > 40 kg/m2 in adults) - this is at study team's discretion.
- Pregnancy or lactation
- Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Susanne M Cabrera, MD
About this study
Official title: The Cardiometabolic Impact of Non-Nutritive Sweeteners in Young Adults With Type 1 Diabetes
This project will apply a novel non-nutritive sweetener (NNS) dietary assessment tool with measurement of circulating NNS levels in a pediatric population, allowing correlation of NNS exposure to clinically meaningful cardiometabolic health outcomes.
Read the detailed description
The purpose of this project is to learn how NNS affects the health of the blood vessels.
Type 1 diabetes (T1D) is an autoimmune disease that requires lifelong dependence on prescribed insulin. Scientists know that if an individual has T1D, they are at greater risk of having cardiovascular disease than people who do not have diabetes.
To help manage diabetes, individuals may talk with their doctor about adjusting what they normally eat or drink. Doctors typically ask that individuals avoid foods and drinks with lots of sugar in them. In response to this, individuals might drink diet drinks or eat snacks or other foods that are sugar-free. Sugar-free drinks and foods have NNS which help things taste sweet without impacting their blood glucose.
Concern exists that consuming NNS may make individuals more at risk for developing cardiovascular disease. Although the American Heart Association advises against long-term NNS consumption, about 20% of all beverages consumed by children contain NNS.
Currently, there are no scientifically backed questionnaires to assess how much NNS someone is consuming. As well, there are no commercially available lab tests to determine how much NNS is in someone's blood. This makes it difficult to draw associations or causal relationships between NNS exposure and health outcomes.
By conducting this project, the investigators hope to gain knowledge to potentially inform and revise care guidelines for individuals with T1D and ultimately lead to improved nutritional recommendations and clinical care of children.
- Being tested
- Cherry Sports Drink
- Keywords
- Non-Nutritive Sweeteners, Type 1 Diabetes, Cardiometabolic, Long standing
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cherry Sports DrinkDietary supplement
Also called Gatorade Zero Glacier Cherry™
12 oz bottle (1 1/2 cups) of Gatorade G Zero Glacier Cherry™ Sports Drink
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Sports Drink - Participants will drink a cherry sports drink within 10 minutes. Receives: Dietary Supplement: Cherry Sports Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in "in vivo" endothelial function and vascular stiffness
Brachial artery ultrasound will measure flow-mediated dilation % (FMD%) at baseline and 1 hour after drinking a non-nutritive sweetened sports drink.
Measured: 2 years (duration of study)
Secondary outcomes (4)
Associations of circulating NNS levels with self-reported food frequency assessments
A food frequency survey has been developed of the most common categories of NNS containing foods and beverages. Participants will complete the food frequency survey to select the frequency by which they consumed a given product and the most common serving size over the past month.
Measured: 2 years (duration of study)
Impact of chronic NNS dietary consumption on cardiovascular health
Changes 1-hour after NNS consumption from baseline will be measured by carotid-femoral pulse wave velocity, baseline flow velocity, and hyperemic flow velocity
Measured: 2 years (duration of study)
Impact of chronic NNS dietary consumption on metabolic health
Changes 1-hour after NNS consumption from baseline will be measured by blood lipids, blood glucose, and blood pressure
Measured: 2 years (duration of study)
Impact of chronic NNS dietary consumption of T1D specific glycemic control
Changes 1-hour after NNS consumption from baseline will be measured by 14-day continuous glucose monitor (CGM) data and 14-day insulin data for total daily dose and % basal insulin
Measured: 2 years (duration of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start5 Aug 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Nutritive SweetenerStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm pre-post study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susanne Cabrera, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434544
- Sponsor's protocol ID
- PRO00057293
- Status last verified
- Oct 2026
- First submitted
- 27 Jan 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No