460 Participants Needed

Sugary to Non-Sugary Beverage Switch for Obesity

(SUB-POP Trial)

DK
TC
Overseen ByTrisha Copeland, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Brigham and Women's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

DT

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

I am between 20 and 69 years old.
You have a body mass index (BMI) between 25 and 45.
I can use a smartphone and am willing to download an app for the study.
See 2 more

Exclusion Criteria

I am not on medication that could change my weight or affect the study.
Pregnant in the past 12 months, currently breastfeeding, or planning to become pregnant during the study period
I have been diagnosed with Phenylketonuria (PKU).
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to one of four beverage groups and receive at-home monthly deliveries of beverages for 6 months.

6 months
In-person clinic visits at baseline, 6 months

Observational

Participants switch to water only for a final 6-month observational period.

6 months
In-person clinic visit at 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Aspartame ASBs
  • Maintain SSBs (Control)
  • Substitute Water
  • Sucralose ASBs
Trial Overview The study is testing if replacing sugary drinks (like soda) with water or artificially-sweetened beverages helps reduce body weight in overweight individuals. Participants will be randomly assigned to one of four groups: some get an app plus non-sugary drinks delivered; others maintain their usual intake.
Participant Groups
5Treatment groups
Experimental Treatment
Active Control
Group I: Substitute WaterExperimental Treatment3 Interventions
Instruction/guidelines to eliminate SSBs and replace with water (months 0-12)
Group II: Substitute Sucralose ASBs (participants randomized through 8/31/2023)Experimental Treatment3 Interventions
Instruction/guidelines to eliminate SSBs and replace, where possible with beverages artificially sweetened with sucralose (months 0-6); then switch to water only (months 6-12)
Group III: Substitute Aspartame ASBs (participants randomized through 8/31/2023)Experimental Treatment3 Interventions
Instruction/guidelines to eliminate SSBs and replace, where possible with beverages artificially sweetened with aspartame (months 0-6); then switch to water only (months 6-12)
Group IV: Substitute ASBs (participants randomized on or after 9/1/2023)Experimental Treatment3 Interventions
Instruction/guidelines to eliminate SSBs and replace, where possible with beverages artificially sweetened with choice of non-nutritive sweeteners such as sucralose or aspartame
Group V: Maintain SSBs (Control)Active Control3 Interventions
Instruction to maintain baseline intake of SSBs (months 0-6); then switch to water only (months 6-12)

Aspartame ASBs is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺
Approved in European Union as Aspartame for:
  • Food additive
  • Sweetener
🇺🇸
Approved in United States as Aspartame for:
  • Food additive
  • Sweetener
🇨🇦
Approved in Canada as Aspartame for:
  • Food additive
  • Sweetener
🇯🇵
Approved in Japan as Aspartame for:
  • Food additive
  • Sweetener
🇨🇳
Approved in China as Aspartame for:
  • Food additive
  • Sweetener
🇨🇭
Approved in Switzerland as Aspartame for:
  • Food additive
  • Sweetener

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

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

Collaborator

Trials
2,513
Recruited
4,366,000+

Findings from Research

In a study of 203 adults over 12 months, replacing sugar-sweetened beverages (SSBs) with artificially sweetened beverages (ASBs) or unsweetened beverages (USBs) did not significantly change serum triglyceride to HDL cholesterol ratios, indicating similar safety profiles for these alternatives.
Participants with higher central adiposity who replaced SSBs with ASBs or USBs experienced less weight gain compared to those who continued consuming SSBs, suggesting that ASBs and USBs can be effective in managing weight in this population.
Effects of Sugar-Sweetened, Artificially Sweetened, and Unsweetened Beverages on Cardiometabolic Risk Factors, Body Composition, and Sweet Taste Preference: A Randomized Controlled Trial.Ebbeling, CB., Feldman, HA., Steltz, SK., et al.[2021]
Replacing sugar-sweetened beverages (SSB) with water can significantly reduce energy intake from beverages, lowering the percentage of energy from 17% to 11% for those consuming one SSB per day, based on data from 19,718 US adults.
This substitution not only improved Healthy Beverage Index scores by 9% to 21% but also predicted a decrease in obesity prevalence, suggesting that drinking water instead of SSB can be an effective strategy for weight management.
Modeling the Effect of Replacing Sugar-Sweetened Beverage Consumption with Water on Energy Intake, HBI Score, and Obesity Prevalence.Duffey, KJ., Poti, J.[2019]
Observational studies suggest that nonnutritive sweeteners (NNSs) might lead to weight gain due to mechanisms related to cravings and addictive behaviors, but interventional studies indicate that replacing sugar-sweetened beverages with NNS can reduce caloric intake and promote modest weight loss.
The effectiveness of NNS for weight reduction may vary based on an individual's baseline diet, dietary changes, and adherence to a comprehensive weight loss program.
The paradox of artificial sweeteners in managing obesity.Roberts, JR.[2022]

References

Effects of Sugar-Sweetened, Artificially Sweetened, and Unsweetened Beverages on Cardiometabolic Risk Factors, Body Composition, and Sweet Taste Preference: A Randomized Controlled Trial. [2021]
Modeling the Effect of Replacing Sugar-Sweetened Beverage Consumption with Water on Energy Intake, HBI Score, and Obesity Prevalence. [2019]
The paradox of artificial sweeteners in managing obesity. [2022]
Impact of acute consumption of beverages containing plant-based or alternative sweetener blends on postprandial appetite, food intake, metabolism, and gastro-intestinal symptoms: Results of the SWEET beverages trial. [2023]
Changes in Non-Nutritive Sweetener Consumption Patterns in Response to a Sugar-Sweetened Beverage Reduction Intervention. [2021]
Rationale, Design and Participants Baseline Characteristics of a Crossover Randomized Controlled Trial of the Effect of Replacing SSBs with NSBs versus Water on Glucose Tolerance, Gut Microbiome and Cardiometabolic Risk in Overweight or Obese Adult SSB Consumer: Strategies to Oppose SUGARS with Non-Nutritive Sweeteners or Water (STOP Sugars NOW) Trial and Ectopic Fat Sub-Study. [2023]
Diet beverages and the risk of obesity, diabetes, and cardiovascular disease: a review of the evidence. [2019]
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