Clinical trial NCT04567108: Health Effects of Substituting Sugary Beverages With Artificially-sweetened Beverages or Water
Official title: SUBstituting With Preferred Options: Health Effects of Substituting Sugar-sweetened Beverages With Non-caloric Beverages in Adults With Overweight and Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Body Weight
Keywords: Prevention
Weight control
Sugar-sweetened beverages
Artificial sweeteners
Water
Beverages
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-09-28
Enrollment: 460
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel randomization on a rolling basis to one of 4 interventions; After 9/1/2023 design is modified to 3 parallel interventions, with sucralose and aspartame interventions combined into one ASB substitution arm
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Weight Change at 6 months
timeFrame: Baseline, Month 6
Secondary outcomes:
measure: Waist Circumference Change
timeFrame: Baseline, Month 6
measure: Sussex Sweet Taste Preference Score Change (0 to 100 where higher score indicates greater liking of sweet taste)
timeFrame: Baseline, Month 6
measure: Beverage Intake Change (oz/d)
timeFrame: Baseline, Month 6
measure: Fasting Plasma Glucose Change
timeFrame: Baseline, Month 6
measure: Fasting Blood Insulin Change
timeFrame: Baseline, Month 6
measure: HOMA-IR Change
timeFrame: Baseline, Month 6
measure: HbA1c Change
timeFrame: Baseline, Month 6
measure: TG/HDL Ratio Change
timeFrame: Baseline, Month 6
measure: Weight Change Sustainability
timeFrame: Baseline, Month 6
Other outcomes:
measure: Waist Circumference Change
timeFrame: Baseline, Month 6, Month 12
measure: Sussex Sweet Taste Preference Score Change (0 to 100 where higher score indicates greater liking of sweet taste)
timeFrame: Baseline, Month 6, Month 12
measure: Total Beverage Intake Change (oz/d)
timeFrame: Baseline, Month 6, Month 12
measure: SSB Beverage Intake Change (oz/d)
timeFrame: Baseline, Month 6, Month 12
measure: ASB Beverage Intake Change (oz/d)
timeFrame: Baseline, Month 6, Month 12
measure: Water Intake Change (oz/d)
timeFrame: Baseline, Month 6, Month 12
measure: HOMA-IR Change
timeFrame: Baseline, Month 6, Month 12
measure: Fasting Blood Insulin Change
timeFrame: Baseline, Month 6, Month 12
measure: Fasting Plasma Glucose Change
timeFrame: Baseline, Month 6, Month 12
measure: HbA1c Change
timeFrame: Baseline, Month 6, Month 12
measure: Triglycerides Change
timeFrame: Baseline, Month 6, Month 12
measure: TG/HDL Change
timeFrame: Baseline, Month 6, Month 12
measure: HDL-C Change
timeFrame: Baseline, Month 6, Month 12
measure: LDL-C Change
timeFrame: Baseline, Month 6, Month 12
measure: Blood Pressure (Systolic and Diastolic) Change
timeFrame: Baseline, Month 6, Month 12
measure: hsCRP Change
timeFrame: Baseline, Month 6, Month 12
measure: Interleukin-6 Change
timeFrame: Baseline, Month 6, Month 12
measure: Alternative Healthy Eating Index 2015 Diet Score Change (Scale 0 to 100 with higher score indicating greater adherence to the dietary pattern)
timeFrame: Baseline, Month 6, Month 12
measure: Self-Reported Added Sugar Change (g/d from 24 hour diet recall)
timeFrame: Baseline, Month 6, Month 12
measure: Self Reported Added Sugar Change (%kcal/d from 24 hour diet recall)
timeFrame: Baseline, Month 6, Month 12
measure: Sweets/Desserts Change (serv/d from 24 hour diet recall)
timeFrame: Baseline, Month 6, Month 12
measure: Total Physical Activity Change (MET-hrs/wk)
timeFrame: Baseline, Month 6, Month 12
measure: 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)
timeFrame: Baseline, Month 6, Month 12
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Deirdre Tobias, ScD
role: PRINCIPAL_INVESTIGATOR
References: