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

NCT04567108 | Active Not Recruiting

• 2 other identifiers: 2020p0024941R01DK125803-01
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Weight

Keywords

Prevention; Weight control; Sugar-sweetened beverages; Artificial sweeteners; Water; Beverages

Outcome Measures

Primary Outcomes (1)

• Weight Change at 6 months

  Change in total body weight calculated as the month 6 weight minus the baseline weight

  Baseline, Month 6

Secondary Outcomes (9)

• Waist Circumference Change

  Baseline, Month 6

• Sussex Sweet Taste Preference Score Change (0 to 100 where higher score indicates greater liking of sweet taste)

  Baseline, Month 6

• Beverage Intake Change (oz/d)

  Baseline, Month 6

• Fasting Plasma Glucose Change

  Baseline, Month 6

• Fasting Blood Insulin Change

  Baseline, Month 6

Other Outcomes (23)

• Waist Circumference Change

  Baseline, Month 6, Month 12

• Sussex Sweet Taste Preference Score Change (0 to 100 where higher score indicates greater liking of sweet taste)

  Baseline, Month 6, Month 12

• Total Beverage Intake Change (oz/d)

  Baseline, Month 6, Month 12

Study Arms (5)

Maintain SSBs (Control)

ACTIVE COMPARATOR

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

Behavioral: Maintain usual SSBs; Behavioral: Study app; Behavioral: Beverage delivery

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

EXPERIMENTAL

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)

Behavioral: Substitute to non-SSBs; Behavioral: Study app; Behavioral: Beverage delivery

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

EXPERIMENTAL

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)

Behavioral: Substitute to non-SSBs; Behavioral: Study app; Behavioral: Beverage delivery

Substitute Water

EXPERIMENTAL

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

Behavioral: Substitute to non-SSBs; Behavioral: Study app; Behavioral: Beverage delivery

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

EXPERIMENTAL

Instruction/guidelines to eliminate SSBs and replace, where possible with beverages artificially sweetened with choice of non-nutritive sweeteners such as sucralose or aspartame

Behavioral: Substitute to non-SSBs; Behavioral: Study app; Behavioral: Beverage delivery

Interventions

Maintain usual SSBs BEHAVIORAL

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

Maintain SSBs (Control)

Study app BEHAVIORAL

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

Maintain SSBs (Control); Substitute ASBs (participants randomized on or after 9/1/2023); Substitute Aspartame ASBs (participants randomized through 8/31/2023); Substitute Sucralose ASBs (participants randomized through 8/31/2023); Substitute Water

Substitute to non-SSBs 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)

Substitute ASBs (participants randomized on or after 9/1/2023); Substitute Aspartame ASBs (participants randomized through 8/31/2023); Substitute Sucralose ASBs (participants randomized through 8/31/2023); Substitute Water

Beverage delivery BEHAVIORAL

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

Maintain SSBs (Control); Substitute ASBs (participants randomized on or after 9/1/2023); Substitute Aspartame ASBs (participants randomized through 8/31/2023); Substitute Sucralose ASBs (participants randomized through 8/31/2023); Substitute Water

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 20-69 years
• 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.)
• BMI 25.0 to 45.0 kg/m2
• Access to a smartphone and willingness and ability to download study app
• Willing to consume beverages consistent with any of the 4 possible group assignments for 6 months

You may not qualify if:

• Physician diagnosis of T2D or fasting glucose ≥126 mg/dL at in-person screening visit
• Intention to move away from greater Boston area within 1 year from randomization
• Major medical illness (known cardiovascular disease, cancer, kidney disease, cirrhosis, etc.)
• Phenylketonuria (PKU)
• Medication that may affect weight or other study endpoints
• Another family or household member participating in the study
• Pregnant in the past 12 months, currently breastfeeding, or planning to become pregnant during the study period

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Deirdre Tobias, ScD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will be blinded to participants' beverage assignment at time of outcome assessment; Investigators will be masked to treatment arm assignments during primary analyses
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Associate Epidemiologist

Model Details: 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

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 28, 2020
• Study Start: April 22, 2021
• Primary Completion (Estimated): May 21, 2026
• Study Completion (Estimated): May 21, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)