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Artificial Sweetener

Sugary to Non-Sugary Beverage Switch for Obesity (SUB-POP Trial)

N/A

Recruiting

Led By Deirdre Tobias, ScD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults aged 20-69 years

Access to a smartphone and willingness and ability to download study app

Must not have

Phenylketonuria (PKU)

Major medical illness (known cardiovascular disease, cancer, kidney disease, cirrhosis, etc.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, month 6, month 12

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether substituting sugar-sweetened beverages for calorie-free alternatives can help reduce body weight and improve health among people who regularly drink sugar-sweetened beverages and are overweight or obese.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the trial primarily involves substituting beverages which may not have direct side effects like drugs do, participants might experience changes in appetite or taste preferences. Artificial sweeteners sometimes cause digestive discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 20 and 69 years old.

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I can use a smartphone and am willing to download an app for the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with Phenylketonuria (PKU).

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I have a major illness like heart disease, cancer, kidney disease, or cirrhosis.

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I have been diagnosed with type 2 diabetes or my fasting glucose level is high.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, month 6, month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, month 6, month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 6, month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Weight Change at 6 months

Secondary study objectives

Beverage Intake Change (oz/d)

TG/HDL Ratio Change

Weight Change Sustainability

Other study objectives

ASB Beverage Intake Change (oz/d)

Alternative Healthy Eating Index 2015 Diet Score Change (Scale 0 to 100 with higher score indicating greater adherence to the dietary pattern)

Blood Pressure (Systolic and Diastolic) Change

+20 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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)

0 / 5Eligibility criteria met