Health Effects of Substituting Sugary Beverages With Artificially-sweetened Beverages or Water

NCT ID: NCT04567108

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 460 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-22
• Study Completion Date: 2026-03-01

Brief Summary

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.

Detailed Description

The SUBstituting with Preferred OPtions (SUB-POP) trial, is a parallel-arm randomized controlled trial (RCT) to test the effects of substituting SSBs with non-caloric options on body weight and markers of type 2 diabetes and cardiometabolic health. Eligible adult participants will be randomized to 1 of 4 beverage groups and receive at-home monthly deliveries of beverages for 6 months. In-person clinic visits will be conducted at baseline, 6, and 12 months. After the 6 months of assigned beverage substitution and delivery, all participants will be instructed to substitute SSBs with water only for a final 6-month observational period. In-person clinic visits will collect technician-measured anthropometrics, blood pressure, biospecimen samples (blood, urine, stool [subset]), and assess physical activity, diet, beverage frequency, and taste preference. The SUB-POP app-based assessments and online diet recall will ascertain daily beverage intake, while diet (via 3 24-hour recalls), physical activity, and overall beverage frequency will be collected every 1-3 months. A subset will receive at-home digital scales to transmit daily body weight for energy balance and caloric compensation modeling. SUB-POP is a novel RCT that will enroll adult regular SSB consumers with overweight or obesity to evaluate the effectiveness of substituting SSBs with non-caloric options in a real-world, un-blinded setting. The trial will leverage social media recruitment methods, achieve ≥30% non-White participants, implement innovative intervention delivery, adherence, and data collection tools, and partition the artificially-sweetened beverage (ASB) substitution intervention to the two most common artificial sweetener types (aspartame, sucralose) to explore potential heterogeneity. Whether ASBs, which are largely free of calories and sugar, provide a healthful interim strategy to transition to water among habitual SSB consumers is unknown. Thus, by addressing this large gap in the understanding of how to address a highly prevalent and concerning dietary exposure, the investigators will inform dietary guidelines and clinical recommendations for the prevention of obesity, type 2 diabetes, and cardiometabolic disease risks. The primary outcomes are change in body weight from baseline to 6 months between the 3 beverage substitution groups (aspartame ASBs, sucralose ASBs, and water) vs. the maintain SSBs control group, adjusting for multiple comparisons. The investigators and staff will be blinded to group assignment at outcome assessments. Intention-to-treat analysis will be used.

After 9/1/2023 the 2 ASB intervention groups (sucralose, aspartame) are combined into a single ASB intervention group; participants randomized on or after 9/1/2023 will be randomized to 1 of 3 beverage groups: maintain SSBs (months 0-6; then switch to water months 6-12); switch to ASBs (months 0-6; then switch to water months 6-12); switch to water (months 0-12). The primary outcomes are change in body weight from baseline to 6 months between the 2 beverage substitution groups (ASBs [all ASB intervention groups combined] and water) vs. the maintain SSBs control group, adjusting for multiple comparisons.

Conditions

Body Weight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Maintain SSBs (Control)

Instruction to maintain baseline intake of SSBs (months 0-6); then switch to water only (months 6-12)

Group Type: ACTIVE_COMPARATOR

Maintain usual SSBs

Intervention Type: BEHAVIORAL

Instruction/guidelines to maintain baseline intake of SSBs (months 0-6); then switch to water only (months 6-12)

Study app

Intervention Type: BEHAVIORAL

Engage with a motivational mobile app to track beverage intake and complete study data collection

Beverage delivery

Intervention Type: BEHAVIORAL

Select from approved beverages for a monthly at-home delivery (months 0-6)

Substitute Aspartame ASBs (participants randomized through 8/31/2023)

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 Type: EXPERIMENTAL

Substitute to non-SSBs

Intervention Type: BEHAVIORAL

Instruction/guidelines to eliminate SSBs and replace, where possible, with beverages consistent to group assignment (months 0-6); then switch to water only (months 6-12)

Study app

Intervention Type: BEHAVIORAL

Engage with a motivational mobile app to track beverage intake and complete study data collection

Beverage delivery

Intervention Type: BEHAVIORAL

Select from approved beverages for a monthly at-home delivery (months 0-6)

Substitute Sucralose ASBs (participants randomized through 8/31/2023)

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 Type: EXPERIMENTAL

Substitute to non-SSBs

Intervention Type: BEHAVIORAL

Instruction/guidelines to eliminate SSBs and replace, where possible, with beverages consistent to group assignment (months 0-6); then switch to water only (months 6-12)

Study app

Intervention Type: BEHAVIORAL

Engage with a motivational mobile app to track beverage intake and complete study data collection

Beverage delivery

Intervention Type: BEHAVIORAL

Select from approved beverages for a monthly at-home delivery (months 0-6)

Substitute Water

Instruction/guidelines to eliminate SSBs and replace with water (months 0-12)

Group Type: EXPERIMENTAL

Substitute to non-SSBs

Intervention Type: BEHAVIORAL

Instruction/guidelines to eliminate SSBs and replace, where possible, with beverages consistent to group assignment (months 0-6); then switch to water only (months 6-12)

Study app

Intervention Type: BEHAVIORAL

Engage with a motivational mobile app to track beverage intake and complete study data collection

Beverage delivery

Intervention Type: BEHAVIORAL

Select from approved beverages for a monthly at-home delivery (months 0-6)

Substitute ASBs (participants randomized on or after 9/1/2023)

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 Type: EXPERIMENTAL

Substitute to non-SSBs

Intervention Type: BEHAVIORAL

Instruction/guidelines to eliminate SSBs and replace, where possible, with beverages consistent to group assignment (months 0-6); then switch to water only (months 6-12)

Study app

Intervention Type: BEHAVIORAL

Engage with a motivational mobile app to track beverage intake and complete study data collection

Beverage delivery

Intervention Type: BEHAVIORAL

Select from approved beverages for a monthly at-home delivery (months 0-6)

Interventions

Maintain usual SSBs

Instruction/guidelines to maintain baseline intake of SSBs (months 0-6); then switch to water only (months 6-12)

Intervention Type: BEHAVIORAL

Substitute to non-SSBs

Instruction/guidelines to eliminate SSBs and replace, where possible, with beverages consistent to group assignment (months 0-6); then switch to water only (months 6-12)

Intervention Type: BEHAVIORAL

Study app

Engage with a motivational mobile app to track beverage intake and complete study data collection

Intervention Type: BEHAVIORAL

Beverage delivery

Select from approved beverages for a monthly at-home delivery (months 0-6)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Adults aged 20-69 years

2. Consume ≥1 serving/day (12 oz.) of SSBs (SSBs include soda, fruit drinks, energy drinks, sports drinks, and sweetened waters, sweetened with high fructose corn syrup, sucrose, or fruit juices. SSBs do not include 100% fruit juice, sweetened teas, or flavored milk.)

3. BMI 25.0 to 45.0 kg/m2

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

5. Willing to consume beverages consistent with any of the 4 possible group assignments for 6 months

Exclusion Criteria

1. Physician diagnosis of T2D or fasting glucose ≥126 mg/dL at in-person screening visit

2. Intention to move away from greater Boston area within 1 year from randomization

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

4. Phenylketonuria (PKU)

5. Medication that may affect weight or other study endpoints

6. Another family or household member participating in the study

7. Pregnant in the past 12 months, currently breastfeeding, or planning to become pregnant during the study period

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Deirdre K Tobias, ScD

Assistant Professor, Associate Epidemiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deirdre Tobias, ScD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

1R01DK125803-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2020p002494

Identifier Type: -

Identifier Source: org_study_id