A trial of sugar-free or sugar-sweetened beverages and body weight in children.

Publication Name: N Engl J Med. 2012 Oct 11;367(15):1397-406. doi: 10.1056/NEJMoa1203034. Epub 2012 Sep 21.

Author(s): de Ruyter JC, Olthof MR, Seidell JC, Katan MB. | Publication Year: 2012

Abstract

BACKGROUND: The consumption of beverages that contain sugar is associated with overweight, possibly because liquid sugars do not lead to a sense of satiety, so the consumption of other foods is not reduced. However, data are lacking to show that the replacement of sugar-containing beverages with noncaloric beverages diminishes weight gain.
METHODS: We conducted an 18-month trial involving 641 primarily normal-weight children from 4 years 10 months to 11 years 11 months of age. Participants were randomly assigned to receive 250 ml (8 oz) per day of a sugar-free, artificially sweetened beverage (sugar-free group) or a similar sugar-containing beverage that provided 104 kcal (sugar group). Beverages were distributed through schools. At 18 months, 26% of the children had stopped consuming the beverages; the data from children who did not complete the study were imputed.
RESULTS: The z score for the body-mass index (BMI, the weight in kilograms divided by the square of the height in meters) increased on average by 0.02 SD units in the sugar-free group and by 0.15 SD units in the sugar group; the 95% confidence interval (CI) of the difference was -0.21 to -0.05. Weight increased by 6.35 kg in the sugar-free group as compared with 7.37 kg in the sugar group (95% CI for the difference, -1.54 to -0.48). The skinfold-thickness measurements, waist-to-height ratio, and fat mass also increased significantly less in the sugar-free group. Adverse events were minor. When we combined measurements at 18 months in 136 children who had discontinued the study with those in 477 children who completed the study, the BMI z score increased by 0.06 SD units in the sugar-free group and by 0.12 SD units in the sugar group (P=0.06).
CONCLUSIONS: Masked replacement of sugar-containing beverages with non-caloric beverages reduced weight gain and fat accumulation in normal-weight children. (Funded by the Netherlands Organization for Health Research and Development and others; DRINK ClinicalTrials.gov number, NCT00893529.).

Summary

In this 18-month, double-blind, randomised clinical trial in 641 normal-weight children (Double-blind, Randomized Intervention Study in Kids (DRINK)), the replacement of a sugar-containing beverage with a sugar-free beverage led to significantly reduced weight gain and body fat gain.

Great strengths of this trial include its double-blind design, the large sample size (641 primarily normal-weight children from 4 years 10 months to 11 years 11 months of age), which was adequate to allow precise outcomes, and the 18-month study duration that ensured that the observed effect was not transient. Previous trials may have yielded inconsistent results because of small samples, short duration, poor adherence, or lack of individual randomization. Measurements of urinary sucralose levels suggested a high rate of adherence in this trial. Based on these findings, confirming also outcomes of previous studies (Ebbeling et al., 2012), the authors conclude that the observed differences in body fat and BMI z score can be ascribed primarily to the assigned beverage.