Sugary to Non-Sugary Beverage Switch for Obesity
(SUB-POP Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it excludes those on medication that may affect weight or other study outcomes. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment Aspartame ASBs, Aspartame, E951, NutraSweet, Equal, Maintain SSBs (Control), Sugar-Sweetened Beverages, SSBs, Substitute Water, Water, H2O, Sucralose ASBs, Splenda, Sucralose Artificially Sweetened Beverages for obesity?
Research shows that replacing sugar-sweetened beverages with water or artificially sweetened beverages can help reduce body weight, especially in individuals with higher body fat. Additionally, replacing sugary drinks with water has been associated with a decrease in energy intake and a potential reduction in obesity prevalence.12345
Is switching from sugary to non-sugary beverages safe for humans?
Research suggests that replacing sugar-sweetened beverages with artificially sweetened or unsweetened ones is generally safe for humans. Studies have shown no significant negative effects on cholesterol levels or weight, and they may even help reduce weight in people with high body fat. However, more research is needed to fully understand the long-term safety of artificial sweeteners.14567
How does the treatment of switching from sugary to non-sugary beverages for obesity differ from other treatments?
This treatment is unique because it focuses on replacing sugar-sweetened beverages with non-sugary options like water and artificially sweetened drinks, which may help reduce weight in people with central obesity (excess fat around the stomach area) without affecting cholesterol levels. Unlike other treatments that might involve medication or surgery, this approach uses everyday beverage choices to potentially improve weight and taste preferences.14567
What is the purpose of this trial?
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.
Research Team
Deirdre Tobias, ScD
Principal Investigator
Brigham and Women's Hospital
Eligibility Criteria
This trial is for adults aged 20-69 with obesity who drink at least one sugary beverage daily and are willing to change their drinking habits. They must have a smartphone, be able to use an app, and not plan to move from the Boston area within a year. People with diabetes, PKU, recent or current pregnancy, weight-affecting medications, or major illnesses cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to one of four beverage groups and receive at-home monthly deliveries of beverages for 6 months.
Observational
Participants switch to water only for a final 6-month observational period.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Aspartame ASBs
- Maintain SSBs (Control)
- Substitute Water
- Sucralose ASBs
Aspartame ASBs is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Food additive
- Sweetener
- Food additive
- Sweetener
- Food additive
- Sweetener
- Food additive
- Sweetener
- Food additive
- Sweetener
- Food additive
- Sweetener
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator