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

NCT04385888 | Completed Results DMC

• 1 other identifier: Pro00012436
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate whether low-calorie sweeteners (LCS) are helpful or harmful for preventing diabetes complications among children with Type 1 Diabetes (T1D).

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Glycemic Variability

  Change in Time in Range (TIR)

  Baseline vs Weeks 11-12

Secondary Outcomes (2)

• Visceral Adiposity

  Baseline vs. Week 12

• Change in Inflammatory Cytokines (TNF-alpha)

  Baseline vs Week 12

Study Arms (2)

Low-calorie sweetener restriction

EXPERIMENTAL

Participants will be instructed to avoid low-calorie sweetened beverages and other sources of low-calorie sweeteners, and to instead consume unsweetened alternatives, such as plain or sparkling water for 12 weeks.

Behavioral: Low-calorie sweetener restriction

Usual consumption/control

NO INTERVENTION

Participants will continue low-calorie sweetener consumption, as usual.

Interventions

Low-calorie sweetener restriction BEHAVIORAL

Participants will avoid low-calorie sweetened beverages and other sources of low-calorie sweeteners for 12 weeks and will instead consume unsweetened alternatives, such as still or sparkling water

Low-calorie sweetener restriction

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child 6-12 years old
• Report consumption of ≥ 12 oz. beverages with sucralose (+/- ace-K) or aspartame+ace-K per day
• Child has had a diagnosis of T1D for at least one year
• Parent/guardian has reliable phone and internet access
• Parent/guardian and child both speak English
• Child is enrolled in the Diabetes Program at Children's National Hospital

You may not qualify if:

• Child under 6 years of age
• Child older than 12 years of age
• Child consumes foods with low-calorie sweeteners more than 3 times per week
• Child consumes condiments with low-calorie sweeteners more than 3 times per week
• Child has poorly managed chronic disease other than T1D or is taking medications other than insulin

Sponsors & Collaborators

• Allison Sylvetsky (Meni): lead
• Children's National Research Institute: collaborator

Study Sites (1)

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (1)

• Sylvetsky AC, Moore HR, Kaidbey JH, Halberg SE, Cogen FR, DiPietro L, Elmi A, Goran MI, Streisand R. Rationale and design of DRINK-T1D: A randomized clinical trial of effects of low-calorie sweetener restriction in children with type 1 diabetes. Contemp Clin Trials. 2021 Jul;106:106431. doi: 10.1016/j.cct.2021.106431. Epub 2021 May 8.

  PMID: 33974993 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Allison Sylvetsky
• Organization: George Washington University

asylvets@gwu.edu

202-994-5602

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 13, 2020
• Study Start: October 28, 2020
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: August 26, 2025
• Results First Posted: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)