Health Effects of Substituting Sugary Beverages With Artificially-sweetened Beverages or Water

NCT04567108 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2026-05-01

No results posted yet for this study

Summary

Sugar-sweetened beverages (SSBs) contribute an alarming \~7% of calories in the US diet among adults, making SSBs the single largest source of added sugar. However, whether artificially sweetened beverages are a healthful alternative for reducing SSB intake among habitual SSB consumers is unknown. Therefore, the investigators will conduct a 4-arm randomized diet intervention trial to test the effects of substituting SSBs with calorie-free alternatives on body weight and health, among habitual SSB consumers with overweight/obesity.

Conditions

  • Body Weight

Interventions

BEHAVIORAL

Maintain usual SSBs

Instruction/guidelines to maintain baseline intake of SSBs (months 0-6); then switch to water only (months 6-12)

BEHAVIORAL

Substitute to non-SSBs

Instruction/guidelines to eliminate SSBs and replace, where possible, with beverages consistent to group assignment (months 0-6); then switch to water only (months 6-12)

BEHAVIORAL

Study app

Engage with a motivational mobile app to track beverage intake and complete study data collection

BEHAVIORAL

Beverage delivery

Select from approved beverages for a monthly at-home delivery (months 0-6)

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH
  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Deirdre Tobias, ScD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-22
Primary Completion
2026-05-21
Completion
2026-05-21

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04567108 on ClinicalTrials.gov