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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Allison Sylvetsky (Meni)
Study ID
NCT04385888
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 12 Years
Healthy Volunteers
Not accepted

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

Study Details

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

Key Dates

Start date
Oct 28, 2020
Status verified
Aug 2025
Primary completion
Dec 30, 2023
Completion
Dec 30, 2023

Study Design

Enrollment
62 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Low-calorie sweetener restriction
    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.
  • No Intervention: Usual consumption/control
    Participants will continue low-calorie sweetener consumption, as usual.

Primary Outcome Measure

Glycemic Variability [ Time Frame: Baseline vs Weeks 11-12 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Children's National HospitalWashington D.C.District of Columbia20010-

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