Substitute Aspartame ASBs for Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
ObesitySubstitute Aspartame ASBs - Behavioral
Eligibility
20 - 69
All Sexes
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Study 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.

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Baseline, Month 6, Month 12

Baseline, Month 6
Beverage Intake Change (oz/d)
TG/HDL Ratio Change
Weight Change Sustainability
Weight Change at 6 months
Month 12
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
Energy Compensation (kcal/d) Estimated from Repeated Body Weights (Assessed via At-Home Scale) vs. Repeated Energy Intake (Derived from Repeated Self-Reported 24-Hour Diet Recalls)
Fasting Blood Insulin Change
Fasting Plasma Glucose Change
HDL-C Change
HOMA-IR Change
HbA1c Change
Interleukin-6 Change
LDL-C Change
SSB Beverage Intake Change (oz/d)
Self Reported Added Sugar Change (%kcal/d from 24 hour diet recall)
Self-Reported Added Sugar Change (g/d from 24 hour diet recall)
Sussex Sweet Taste Preference Score Change (0 to 100 where higher score indicates greater liking of sweet taste)
Sweets/Desserts Change (serv/d from 24 hour diet recall)
TG/HDL Change
Total Beverage Intake Change (oz/d)
Total Physical Activity Change (MET-hrs/wk)
Triglycerides Change
Waist Circumference Change
Water Intake Change (oz/d)
hsCRP Change

Trial Safety

Trial Design

4 Treatment Groups

Maintain SSBs (Control)
1 of 4
Substitute Sucralose ASBs
1 of 4
Substitute Aspartame ASBs
1 of 4
Substitute Water
1 of 4

Active Control

Experimental Treatment

540 Total Participants · 4 Treatment Groups

Primary Treatment: Substitute Aspartame ASBs · No Placebo Group · N/A

Substitute Sucralose ASBs
Behavioral
Experimental Group · 1 Intervention: Substitute Sucralose ASBs · Intervention Types: Behavioral
Substitute Aspartame ASBs
Behavioral
Experimental Group · 1 Intervention: Substitute Aspartame ASBs · Intervention Types: Behavioral
Substitute Water
Behavioral
Experimental Group · 1 Intervention: Substitute Water · Intervention Types: Behavioral
Maintain SSBs (Control)
Behavioral
ActiveComparator Group · 1 Intervention: Maintain SSBs (Control) · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, month 6, month 12

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,148 Previous Clinical Trials
4,074,209 Total Patients Enrolled
404 Trials studying Obesity
492,985 Patients Enrolled for Obesity
Brigham and Women's HospitalLead Sponsor
1,480 Previous Clinical Trials
9,735,241 Total Patients Enrolled
41 Trials studying Obesity
77,741 Patients Enrolled for Obesity
Deirdre Tobias, ScDPrincipal InvestigatorBrigham and Women's Hospital

Eligibility Criteria

Age 20 - 69 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
I am willing to drink any beverage that is assigned to me for the next 6 months.
The ability to have access to a smartphone and the willingness and ability to download a study app are important factors for students who want to succeed in their studies.
A person who has a BMI between 25.0 and 45.0 kg/m2 is considered to be overweight.