# Effects of Low-calorie Sweetened Beverage Restriction in Youth with Type 1 Diabetes

> **NIH NIH R21** · GEORGE WASHINGTON UNIVERSITY · 2021 · $252,215

## Abstract

Abstract
This project aims to determine whether replacement of beverages containing low-calorie sweeteners (hereafter
LCSB) with unsweetened still or seltzer water improves glycemic variability (time in target range) and reduces
visceral adiposity and systemic inflammation in children with type 1 diabetes (T1D). While LCSB are widely
consumed in youth with T1D, their role in cardiometabolic health is controversial. LCS consumption is reported
to promote glucose intolerance in rodents and humans, and incubation of human mesenchymcal stem cells
with sucralose at clinically relevant doses upregulated expression of glucose transporter genes as well as
markers of fat accumulation and inflammation. This is alarming because inflammation and hyperglycemia drive
early cardiovascular disease (CVD) in youth with T1D and positive associations between LCS consumption,
CVD, and stroke are consistently reported in observational analyses in adults without diabetes. These findings
are particularly concerning for patients with T1D, who already struggle with glycemic control and are at
heightened cardiometabolic risk. To address these outcomes, we plan to conduct a two-arm randomized
controlled trial comparing effects of replacement of usual sucralose or aspartame + acesulfame-potassium
containing LCSB consumption (the majority of LCSB consumed by children contain either sucralose or
aspartame + ace-K) with unsweetened still or seltzer water for 12 weeks (referred to as LCSB restriction) on
glycemic variability, visceral adiposity, and systematic inflammation in 60 children ages 6-12 years old with
T1D. We will also examine the feasibility and acceptability of the proposed intervention and monitor adherence
using both self-report and objective (urinary sucralose and acesulfame-potassium) measures. Blinded
continuous glucose monitoring (CGM), MRI, and blood assays will be performed at baseline, after which
participants will be randomized to either LCSB restriction or continuation of usual LCSB intake (control).
Participants in both groups will be instructed to complete photo-assisted, online, three day food records, with
the help of their parents, during weeks 1, 6, and 12. All participants and their parent will receive instructions on
how to complete photo-assisted food records, education on continuous glucose monitoring (CGM), and
counseling on general healthy eating strategies. Those in the intervention group will receive additional
guidance on how to avoid LCSB. CGM, blood assays and MRI will be performed again at study follow up. If
LCSB restriction improves glycemic variability and lowers visceral adiposity and systemic inflammation, these
findings will inform the development of a larger and longer-term trial to elucidate mechanisms underlying LCS
effects and will justify or challenge the standard practice of encouraging LCSB among children with T1D.

## Key facts

- **NIH application ID:** 10130523
- **Project number:** 5R21DK122345-02
- **Recipient organization:** GEORGE WASHINGTON UNIVERSITY
- **Principal Investigator:** Allison Sylvetsky
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $252,215
- **Award type:** 5
- **Project period:** 2020-04-01 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10130523

## Citation

> US National Institutes of Health, RePORTER application 10130523, Effects of Low-calorie Sweetened Beverage Restriction in Youth with Type 1 Diabetes (5R21DK122345-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10130523. Licensed CC0.

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