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
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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