Energy restriction with ultra-processed food restriction yields greater weight loss than generic energy restriction in obesity

This randomized clinical trial evaluated 148 individuals with obesity over a 12.0-month follow-up period. Participants were randomized to either energy restriction associated with ultra-processed food restriction (ER-UPF) or generic energy restriction (ER-G). The study aimed to assess weight loss and metabolic effects while monitoring ultra-processed food intake and body composition.

The primary outcome measured was weight loss. At 12 months, the ER-UPF group lost 82.9 kg of bodyweight, whereas the ER-G group lost 86.3 kg. The difference in weight loss between the groups was statistically significant with a p-value of 0.01. Regarding ultra-processed food intake, the ER-UPF group decreased from 21.16% to 13.86%, while the ER-G group decreased from 23.70% to 20.02%. This difference in UPF intake was not statistically significant with a p-value of 0.08.

The NOVA-UPF Score decreased in the ER-UPF group from 2.74 to 1.86, compared to a decrease from 2.62 to 2.47 in the ER-G group. This reduction in the NOVA-UPF Score was statistically significant with a p-value of 0.03. Safety data regarding adverse events, serious adverse events, discontinuations, and tolerability were not reported in the study. A key limitation was that individuals in the trial had low ultra-processed food intake at baseline.

While the ER-UPF intervention showed statistical advantages in weight loss and ultra-processed food score reduction, the authors caution that the greater weight loss was statistically, but non-clinically significant. Consequently, the practice relevance of these specific findings remains uncertain given the baseline characteristics and the nature of the observed differences.