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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 6, month 12
Awards & highlights

SUB-POP Trial 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.Check my eligibility
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.See study design
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.

SUB-POP Trial 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.

SUB-POP Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Weight Change at 6 months
Secondary outcome measures
Beverage Intake Change (oz/d)
TG/HDL Ratio Change
Weight Change Sustainability
Other outcome measures
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

SUB-POP 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)

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,604 Previous Clinical Trials
11,466,477 Total Patients Enrolled
46 Trials studying Obesity
78,175 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,348 Previous Clinical Trials
4,314,272 Total Patients Enrolled
445 Trials studying Obesity
588,595 Patients Enrolled for Obesity
Deirdre Tobias, ScDPrincipal InvestigatorBrigham and Women's Hospital

Media Library

Aspartame ASBs (Artificial Sweetener) Clinical Trial Eligibility Overview. Trial Name: NCT04567108 — N/A
Obesity Research Study Groups: Substitute Aspartame ASBs (participants randomized through 8/31/2023), Substitute Sucralose ASBs (participants randomized through 8/31/2023), Substitute ASBs (participants randomized on or after 9/1/2023), Maintain SSBs (Control), Substitute Water
Obesity Clinical Trial 2023: Aspartame ASBs Highlights & Side Effects. Trial Name: NCT04567108 — N/A
Aspartame ASBs (Artificial Sweetener) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04567108 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to join this medical experiment?

"In order to be considered, potential participants must have a BMI between 20 and 69. The study organisers are aiming to recruit 540 individuals in total."

Answered by AI

Is enrollment for this experiment still available to individuals seeking treatment?

"Affirmative. According to clinicaltrials.gov, this research is actively pursuing participants for enrollment. It was originally advertised on April 22nd 2021 and the listing has been modified most recently on August 1st 2022. The investigation calls for 540 individuals from a single medical centre to take part in it."

Answered by AI

Does the eligibility criteria of this medical study encompass individuals aged 35 or older?

"Eligible participants for this medical trial must be aged between 20 to 69 years old."

Answered by AI

What is the total cohort size of this research project?

"Affirmative. According to the information on clinicaltrials.gov, this trial is actively enrolling participants starting from April 22nd 2021 and was most recently updated on August 1st 2022. 540 individuals are required across a single site for this study's completion."

Answered by AI
~131 spots leftby Jun 2025