• Hisashi Yoshimoto, Kyoko Kawaida, Shohei Dobashi, Go Saito, and Yukiko Owaki.
• Research and Development Center for Lifestyle Innovation, University of Tsukuba, 1-2 Kasuga, Tsukuba, Ibaraki, 305-8550, Japan. hisashiyoshi@md.tsukuba.ac.jp.
• Bmc Med. 2023 Oct 2; 21 (1): 379379.

BackgroundThe use of alcohol-flavored beverages not containing alcohol (hereinafter referred to as non-alcoholic beverages) is recommended to reduce alcohol consumption. However, it is unclear if this reduces excessive drinking.ObjectiveTo verify whether non-alcoholic beverages impact the alcohol consumption of excessive drinkers.Study DesignSingle-center, open-label, randomized, parallel-group study.MethodsParticipants aged 20 years or older who were not diagnosed with alcoholism, who drank at least four times a week, and whose alcohol consumption on those days was at least 40 g in males and 20 g in females, were recruited. Participants were randomized into the intervention or control group by simple randomization using a random number table. In the intervention group, free non-alcoholic beverages were provided once every 4 weeks for 12 weeks (three times in total), and thereafter, the number of alcoholic and non-alcoholic beverages consumed were recorded for up to 20 weeks. The consumption of alcoholic and non-alcoholic beverages was calculated based on a drinking diary submitted with the previous 4 weeks of data. The primary endpoint was the change from baseline in total alcohol consumption during past 4 weeks at week 12. The participants were not blinded to group allocations.ResultsFifty-four participants (43.9%) were allocated to the intervention group and 69 (56.1%) to the control group. None of the participants in the intervention group dropped out, compared to two (1.6%) in the control group. The change in alcohol consumption was - 320.8 g (standard deviation [SD], 283.6) in the intervention group and - 76.9 g (SD, 272.6) in the control group at Week 12, indicating a significant difference (p < 0.001). Even at Week 20 (8 weeks after the completion of the intervention), the change was - 276.9 g (SD, 39.1) in the intervention group, which was significantly greater than - 126.1 g (SD, 41.3) in the control group (p < 0.001). The Spearman rank correlation coefficient between the change in non-alcoholic beverage consumption and alcohol consumption at Week 12 was significantly negative only in the intervention group (ρ =  - 0.500, p < 0.001). There were no reports of adverse events during the study.ConclusionsProviding non-alcoholic beverages significantly reduced alcohol consumption, an effect that persisted for 8 weeks after the intervention.Trial RegistrationUMIN UMIN000047949. Registered 4 June 2022.© 2023. BioMed Central Ltd., part of Springer Nature.

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