Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Location contact
Susanne M Cabrera, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07434544
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.
Trial opening soon.
Get Notified15 year–24 year
All sexes
Interventional
Not applicable
Milwaukee, Wisconsin, 53226, United States
Susanne M Cabrera, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
12 oz bottle (1 1/2 cups) of Gatorade G Zero Glacier Cherry™ Sports Drink
Other names: Gatorade Zero Glacier Cherry™
Time frame: 2 years (duration of study)
Brachial artery ultrasound will measure flow-mediated dilation % (FMD%) at baseline and 1 hour after drinking a non-nutritive sweetened sports drink.
Time frame: 2 years (duration of study)
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.
Time frame: 2 years (duration of study)
Changes 1-hour after NNS consumption from baseline will be measured by carotid-femoral pulse wave velocity, baseline flow velocity, and hyperemic flow velocity
Time frame: 2 years (duration of study)
Changes 1-hour after NNS consumption from baseline will be measured by blood lipids, blood glucose, and blood pressure
Time frame: 2 years (duration of study)
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
Contact information is provided by the study sponsor or research team.
Medical College of Wisconsin
Other
The Cardiometabolic Impact of Non-Nutritive Sweeteners in Young Adults With Type 1 Diabetes
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