Harrold · International journal of obesity (2005) 2024 · parallel-group, open-label randomized controlled trial · n=493

Non-nutritive sweetened beverages versus water after a 52-week weight management programme: a randomised controlled trial.

Cited 27 times in the scientific literature.

Level 2 - randomized trial

Individual randomized controlled equivalence trial in humans

PubMed 37794246 · doi:10.1038/s41366-023-01393-3 · record verified 2026-08-29

What was done

A 52-week, parallel-group, open-label randomized controlled equivalence trial (NCT02591134) evaluated 493 adults with overweight or obesity (BMI 27–35 kg/m²) who regularly consumed cold beverages. Participants were randomized 1:1 to consume either water (n = 246) or non-nutritive sweetened (NNS) beverages (n = 247) alongside a behavioral weight management program (12-week active weight-loss phase with weekly meetings, followed by a 40-week maintenance phase with monthly meetings). The primary endpoint was total weight change at week 52.

What was found

At 52 weeks, the two interventions were non-equivalent: participants in the NNS beverage group lost an average of 7.5 kg compared to 6.1 kg in the water group. The difference was statistically significant in favor of NNS beverages (difference: 1.4 kg, 90% CI: -2.6 to -0.2 kg; p < 0.05), although the authors noted this magnitude was not clinically significant. Numerical results for secondary endpoints (cardiometabolic risk factors, appetite, activity) were not reported in the abstract.

Why it matters

This trial provides long-term evidence addressing concerns that non-nutritive sweeteners undermine weight management, demonstrating that NNS beverages perform at least as well as water over a one-year behavioral program.

Limits

The open-label design could introduce performance bias; 75.9% of participants were already regular consumers of NNS beverages prior to enrollment; the cohort was restricted to individuals with BMI 27–35 kg/m² who regularly drink cold beverages; and numerical data for secondary cardiometabolic and behavioral endpoints were omitted from the abstract.

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