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

Body Weight Clinical Trial

— SUB-POP  

Official title:

SUBstituting With Preferred Options: Health Effects of Substituting Sugar-sweetened Beverages With Non-caloric Beverages in Adults With Overweight and Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04567108
• Other study ID #: 2020p002494
• Secondary ID: 1R01DK125803-01
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2021
• Est. completion date: June 1, 2025

Study information

• Verified date: September 2023
• Source: Brigham and Women's Hospital
• Contact: Deirdre K Tobias, ScD
• Phone: 617-732-5500
• Email: dtobias[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 460
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight

Intervention

Behavioral:
• Maintain usual SSBs
Instruction/guidelines to maintain baseline intake of SSBs (months 0-6); then switch to water only (months 6-12)
• 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)
• Study app
Engage with a motivational mobile app to track beverage intake and complete study data collection
• Beverage delivery
Select from approved beverages for a monthly at-home delivery (months 0-6)

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Waist Circumference Change	Calculated as month 6 minus baseline value, month 12 minus month 6 value	Baseline, Month 6, Month 12
Other	Sussex Sweet Taste Preference Score Change (0 to 100 where higher score indicates greater liking of sweet taste)	Calculated as month 6 minus baseline value, month 12 minus month 6 value	Baseline, Month 6, Month 12
Other	Total Beverage Intake Change (oz/d)	Calculated as month 6 minus baseline value, month 12 minus month 6 value	Baseline, Month 6, Month 12
Other	SSB Beverage Intake Change (oz/d)	Calculated as month 6 minus baseline value, month 12 minus month 6 value	Baseline, Month 6, Month 12
Other	ASB Beverage Intake Change (oz/d)	Calculated as month 6 minus baseline value, month 12 minus month 6 value	Baseline, Month 6, Month 12
Other	Water Intake Change (oz/d)	Calculated as month 6 minus baseline value, month 12 minus month 6 value	Baseline, Month 6, Month 12
Other	HOMA-IR Change	Calculated as month 6 minus baseline value, month 12 minus month 6 value	Baseline, Month 6, Month 12
Other	Fasting Blood Insulin Change	Calculated as month 6 minus baseline value, month 12 minus month 6 value	Baseline, Month 6, Month 12
Other	Fasting Plasma Glucose Change	Calculated as month 6 minus baseline value, month 12 minus month 6 value	Baseline, Month 6, Month 12
Other	HbA1c Change	Calculated as month 6 minus baseline value, month 12 minus month 6 value	Baseline, Month 6, Month 12
Other	Triglycerides Change	Calculated as month 6 minus baseline value, month 12 minus month 6 value	Baseline, Month 6, Month 12
Other	TG/HDL Change	Calculated as month 6 minus baseline value, month 12 minus month 6 value	Baseline, Month 6, Month 12
Other	HDL-C Change	Calculated as month 6 minus baseline value, month 12 minus month 6 value	Baseline, Month 6, Month 12
Other	LDL-C Change	Calculated as month 6 minus baseline value, month 12 minus month 6 value	Baseline, Month 6, Month 12
Other	Blood Pressure (Systolic and Diastolic) Change	Calculated as month 6 minus baseline value, month 12 minus month 6 value	Baseline, Month 6, Month 12
Other	hsCRP Change	Calculated as month 6 minus baseline value, month 12 minus month 6 value	Baseline, Month 6, Month 12
Other	Interleukin-6 Change	Calculated as month 6 minus baseline value, month 12 minus month 6 value	Baseline, Month 6, Month 12
Other	Alternative Healthy Eating Index 2015 Diet Score Change (Scale 0 to 100 with higher score indicating greater adherence to the dietary pattern)	Calculated as month 6 minus baseline value, month 12 minus month 6 value	Baseline, Month 6, Month 12
Other	Self-Reported Added Sugar Change (g/d from 24 hour diet recall)	Calculated as month 6 minus baseline value, month 12 minus month 6 value	Baseline, Month 6, Month 12
Other	Self Reported Added Sugar Change (%kcal/d from 24 hour diet recall)	Calculated as month 6 minus baseline value, month 12 minus month 6 value	Baseline, Month 6, Month 12
Other	Sweets/Desserts Change (serv/d from 24 hour diet recall)	Calculated as month 6 minus baseline value, month 12 minus month 6 value	Baseline, Month 6, Month 12
Other	Total Physical Activity Change (MET-hrs/wk)	Calculated as month 6 minus baseline value, month 12 minus month 6 value	Baseline, Month 6, Month 12
Other	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)	Calculated as month 6 minus baseline value, month 12 minus month 6 value	Baseline, Month 6, Month 12
Primary	Weight Change at 6 months	Change in total body weight calculated as the month 6 weight minus the baseline weight	Baseline, Month 6
Secondary	Waist Circumference Change	Calculated as month 6 minus baseline value	Baseline, Month 6
Secondary	Sussex Sweet Taste Preference Score Change (0 to 100 where higher score indicates greater liking of sweet taste)	Calculated as month 6 minus baseline value	Baseline, Month 6
Secondary	Beverage Intake Change (oz/d)	Calculated as month 6 minus baseline value	Baseline, Month 6
Secondary	Fasting Plasma Glucose Change	Calculated as month 6 minus baseline value	Baseline, Month 6
Secondary	Fasting Blood Insulin Change	Calculated as month 6 minus baseline value	Baseline, Month 6
Secondary	HOMA-IR Change	Calculated as month 6 minus baseline value	Baseline, Month 6
Secondary	HbA1c Change	Calculated as month 6 minus baseline value	Baseline, Month 6
Secondary	TG/HDL Ratio Change	Calculated as month 6 minus baseline value	Baseline, Month 6
Secondary	Weight Change Sustainability	Calculated as month 6 minus baseline value, month 12 minus month 6 value	Baseline, Month 6