Sugary to Non-Sugary Beverage Switch for Obesity

(SUB-POP Trial)

Overseen By Trisha Copeland, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must not be taking: Weight affecting

Disqualifiers: T2D, Cardiovascular disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

Duration: 6 months

460 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 5}

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. ^{1 2 4 6 7}

Who Is on the Research Team?

Deirdre Tobias, ScD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

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.

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).

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Substitute Water Experimental Treatment 3 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 Treatment 3 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 Treatment 3 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 Treatment 3 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 Control 3 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

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The paradox of artificial sweeteners in managing obesity. Roberts, JR.[2022]

In a study involving 60 healthy volunteers with overweight/obesity, non-nutritive sweeteners (S&SE) significantly reduced insulin levels after a carbohydrate-rich meal compared to sucrose, indicating potential benefits for glycaemic control.

While some S&SE blends affected cholesterol levels and appetite sensations, they did not lead to significant differences in overall energy intake or cause serious gastrointestinal issues, suggesting they may be a safe alternative to sugar.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Almiron-Roig, E., Navas-Carretero, S., Castelnuovo, G., et al.[2023]

In a 6-month intervention study with 101 participants, there was a significant increase in non-nutritive sweetener (NNS) consumption, particularly aspartame and total NNS, suggesting that NNS may help reduce sugar-sweetened beverage (SSB) intake.

Despite the increase in NNS consumption, there were no significant changes in weight or body mass index (BMI) among different SSB-NNS change groups, indicating that while NNS can be used to decrease SSB consumption, their impact on weight management may need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in Non-Nutritive Sweetener Consumption Patterns in Response to a Sugar-Sweetened Beverage Reduction Intervention. Acero, D., Zoellner, JM., Davy, BM., et al.[2021]

The STOP Sugars NOW trial is a randomized controlled trial involving 80 overweight or obese adults, aiming to compare the effects of non-nutritive sweetened beverages (NSBs) and water as replacements for sugar-sweetened beverages (SSBs) on glucose tolerance and gut microbiota diversity.

Preliminary results indicate that the trial is designed to provide high-level evidence on the safety and efficacy of NSBs in reducing sugar intake, which could influence clinical guidelines and public health policies regarding beverage consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Ayoub-Charette, S., McGlynn, ND., Lee, D., et al.[2023]

The review highlights that while artificial sweeteners (ASBs) are often marketed for weight control, the actual consumption of diet beverages is lower than that of sugar-sweetened beverages (SSBs), with those trying to lose weight consuming the most ASBs.

Current evidence suggests that replacing SSBs with ASBs may lower obesity risk, but more experimental studies are needed to fully understand the long-term benefits and risks of frequent ASB consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet beverages and the risk of obesity, diabetes, and cardiovascular disease: a review of the evidence. Pereira, MA.[2019]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Effects of Sugar-Sweetened, Artificially Sweetened, and Unsweetened Beverages on Cardiometabolic Risk Factors, Body Composition, and Sweet Taste Preference: A Randomized Controlled Trial. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Modeling the Effect of Replacing Sugar-Sweetened Beverage Consumption with Water on Energy Intake, HBI Score, and Obesity Prevalence. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

The paradox of artificial sweeteners in managing obesity. [2022]

4. England pubmed.ncbi.nlm.nih.gov

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]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Changes in Non-Nutritive Sweetener Consumption Patterns in Response to a Sugar-Sweetened Beverage Reduction Intervention. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

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]

7. United States pubmed.ncbi.nlm.nih.gov

Diet beverages and the risk of obesity, diabetes, and cardiovascular disease: a review of the evidence. [2019]