Active — Not RecruitingNot Applicable

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

United States460 participantsStarted 2021-04-22

Plain-language 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.

Who can participate

Age range20 Years – 69 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Weight Change at 6 months

Timeframe: Baseline, Month 6

Trial details

NCT IDNCT04567108

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-21

View on ClinicalTrials.gov More Body Weight trials