(2023) 21:379
Yoshimoto et al. BMC Medicine
https://doi.org/10.1186/s12916-023-03085-1

BMC Medicine

RESEARCH ARTICLE

Open Access

Effect of provision of non‑alcoholic
beverages on alcohol consumption:a randomized controlled study
Hisashi Yoshimoto1,2* , Kyoko Kawaida1, Shohei Dobashi1, Go Saito1,3 and Yukiko Owaki1

Abstract
Background The 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.
Objective To verify whether non-alcoholic beverages impact the alcohol consumption of excessive drinkers.
Study design Single-center, open-label, randomized, parallel-group study.
Methods Participants aged 20 years or older who were not diagnosed with alcoholism, who drank at least fourtimes a week, and whose alcohol consumption on those days was at least 40 g in males and 20 g in females, wererecruited. Participants were randomized into the intervention or control group by simple randomization usinga 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 basedon 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.
Results Fifty-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. Thechange 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.
Conclusions Providing non-alcoholic beverages significantly reduced alcohol consumption, an effect that persisted
for 8 weeks after the intervention.
Trial registration UMIN UMIN000047949. Registered 4 June 2022.
Keywords Non-alcoholic beverages, Reduced alcohol consumption, Randomized controlled study*Correspondence:
Hisashi Yoshimoto
hisashiyoshi@md.tsukuba.ac.jp
Full list of author information is available at the end of the article© The Author(s) 2023. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which
permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to theoriginal author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images orother third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line
to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory
regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of thislicence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Yoshimoto et al. BMC Medicine(2023) 21:379

Background
Excessive alcohol consumption is a global public healthissue. In 2020, an estimated 1.34 billion people (1.03 billion males and 310 million females) consumed a harmful amount of alcohol [1], and more than 3 million people
are dying from alcohol-related problems per year worldwide [2]. The World Health Organization (WHO) claims
that excessive drinking not only causes health problems,
including alcoholism, but also leads to other serious
issues, including domestic violence and traffic accidents
due to drunk driving. Thus, it is recommending evidencebased measures such as price increases and taxation on
alcohol beverages, permitting only certified stores to sell
alcohol, and strengthening penalties for underage drinking and drunk driving [3]. Japan is relatively permissive
regarding drinking: for instance, there is an “all-you-candrink” system in some restaurants [4], and alcoholic beverages are available for purchase 24 hours a day, every day
throughout the year. The need for measures to improve
this situation has been pointed out in an international
report [5].
In Japan, efforts to reduce excessive drinking have been
made through Health Japan 21, a program that constitutes
Japan’s primary prevention strategy, and the enforcementof the Basic Law on Measures to Prevent Damage to
Health Due to Alcohol, but their effects have been insufficient [5]. The “amount of alcohol that increases the riskof lifestyle diseases” is defined in Japan as pure alcohol
consumption (hereinafter referred to as “alcohol consumption”) of 40 g/day or more in men and 20 g/day ormore in women [6–8]. In 2019, it was reported that compared to 2010, the percentage of people who drank theabove amounts did not increase or decrease in men andsignificantly increased in women [5]. One of the criticalgoals of Health Japan 21 is to reduce the number of people who drink alcohol in amounts that increase the risk oflifestyle diseases, and since this has not been achieved, it
is necessary to take additional measures.
One strategy that has been discussed is the use of lowalcohol or non-alcoholic beverages [9]. Non-alcoholic
beverages are alcohol-flavored beverages that contain no
alcohol. They are alternatives to alcoholic beverages, andtheoretically, if they replace alcoholic beverages, this maylead to public health benefits [10]. In its Global Strategy
to Reduce Harmful Use of Alcohol, the WHO requests
that the alcohol industry contributes to decreasing theharmful use of alcohol, for example by reducing the alcohol content of its products [11]. Rehm et al. identified thefollowing three ways in which low-alcohol or non-alcoholic beverages may impact the harmful use of alcohol:(1) replacing standard alcoholic beverages with similar
low-alcohol beverages may lead to the consumption ofbeverages with lower alcohol content without increasing

Page 2 of 10

the amount of liquid consumed; (2) replacing alcoholic
beverages with non-alcoholic beverages for a certain
period of time may allow drinkers to reduce their mean
ethanol consumption; and (3) consumption of low-alcohol or non-alcoholic beverages may lead to the resumption of alcohol use by people who have been abstaining
from alcohol [12]. Thus, non-alcoholic beverages can be
an effective tool for reduction of alcohol consumption
among excessive drinkers.
There is currently limited evidence on the effect of
non-alcoholic beverages [13], with insufficient researchon whether providing non-alcoholic beverages directly
affects alcohol consumption. We examined this question in a randomized controlled study in excessive drinkers, excluding those with alcoholism. It is extremely
valuable to verify effective methods for reducing alcohol
consumption, not only for developing interventions forindividuals, but also for formulating global strategies andcommunity approaches such as policymaking.

Methods
Study design

This was a single-center, open-label, randomized, parallelgroup study.
ParticipantsWith reference to preceding studies [14, 15], the eligibility criteria for participants in this study were specified asfollows: (1) at least 20 years of age and (2) drinking on
4 or more days per week, with alcohol consumption ofat least 40 g for men or 20 g for women on each of thedays. The exclusion criteria were consumption of nonalcoholic beverages at least twice per month, past historyof liver disease, current pregnancy or nursing, alcoholism, lack of consent for the use of LINE® (a messaging
application widely used in Japan that can be used on personal computers or smartphones; LINE Corp., Shinjukuku, Tokyo, Japan), and inability to understand the study
explanation or answer the online survey conducted inadvance, both of which were written only in Japanese.
This study excluded individuals with alcoholism because
it has been suggested that their use of non-alcoholic beverages may enhance alcohol craving and stimulate thedesire to drink, which may increase the risk of drinking
relapse [16].
Setting

The survey was conducted from May 2022 to January
2023. Participants were recruited from May 30 to July
15, 2022, through the employee website of the University of Tsukuba, by putting up flyers inside and outside
the University of Tsukuba campus, and by snowball
sampling by the study personnel. The participants wereYoshimoto et al. BMC Medicine(2023) 21:379

randomly allocated to either the intervention or control
group. People who wished to participate in the study
were asked to answer an online questionnaire in advanceto confirm eligibility and exclusion criteria, as well as toparticipate in an in-person 2-h briefing held on the University of Tsukuba campus and to provide written consent to participate. Nine briefings were held, and thenumber of attendees at each meeting was restricted to
15 as a COVID-19 prevention measure. In addition tointerviews for alcoholism with physicians, measurementof height and weight and collection of saliva samples, this2-h face-to-face orientation session prior to randomization included careful explanation about this study. We
explained the effect of providing non-alcoholic beverages
on alcohol consumption was unknown. We also asked
participants in both groups to go about their daily lives
as usual, with the exception of keeping a drinking diary.
Procedures

The study procedures are described in Table 1. Week 0of the study was defined as the start of the intervention.
In the preparation period, the number of weeks wascounted backwards, specifically Week (-4) and Week(-2). After the start of the intervention, the numbers
of weeks were specified as Week 4, Week 8, and Week
12, and in the follow-up period, they were specified as
Week 16 and Week 20. At Week (-4), a study briefing
was held, including an interview with a physician experienced in the diagnosis and treatment of alcoholism

Page 3 of 10

to initially confirm eligibility criteria. Two physicians
were in charge of interviews. Each individual wasinterviewed by one of these physicians, who independently formulated the diagnosis. All individuals who
met the eligibility criteria underwent a group briefing,
and consent to participate was obtained in writing. At
this briefing, participants completed a questionnaire
regarding basic attributes, information about drinking,and other factors; in addition, height and body weight
were measured and a saliva test was administered toassess the activity of genes related to alcohol metabolism. After the briefing, the participants were randomized to either the intervention or control group by
simple randomization using a random number table[17]. To prepare for the provision of the non-alcoholic
beverages described below, at Week (-2), participants
were told which group they were allocated to. During
the post-allocation period (the intervention period,
from Week 4 to Week 12) and the follow-up period,
the participants in both groups were asked to record
their consumption of alcoholic and non-alcoholic beverages in a drinking diary every day and to submit it
every 4 weeks. After the briefing, the study participants
were contacted only by phone or via internet. At theend of the study, a gift card worth 10,000 yen (approximately 73.67 US dollars) was given to all participants
as a reward. In addition, each participant in the control
group received up to five cases of non-alcoholic beverages of their choice.

Table 1 Study procedures

I intervention group, C control group, X all participantsaUp to 3 cases of non-alcoholic beverages were provided at a time; each contained 24 350-mL bottles according to each participant’s requestb

Up to 5 cases of non-alcoholic beverages were provided, each containing 24 350-mL bottles according to each participant’s request

Yoshimoto et al. BMC Medicine(2023) 21:379

Intervention

During the 12-week intervention period, free non-alcoholic beverages were provided once every 4 weeks (threetimes in total). Each case included 24 350-mL bottles.
Up to three cases were provided at a time, with the exact
number depending on each participant’s preference. Participants selected beverages from among 22 products
from four manufacturers, specifically the six top-ranked
beer-flavored products and the 16 top-ranked cocktailflavored products according to the sales ranking in theJapanese market in 2021. The selected non-alcoholic beverages were shipped to participants’ homes by a package
delivery company.
Measurement

The self-administered questionnaire used in the briefing
included questions regarding basic attributes such as age,sex, race, marital status, the highest level of education,
employment status, household income, smoking history,
and subjective view of health [18], as well as the Alcohol
Quality of Life Scale (AQoLS) [19] and questions related
to drinking, such as the Alcohol Use Disorders Identification Test (AUDIT) [20] and the number of binge-drinking
episodes within the past 1 month. The definition of binge
drinking varies across studies, but it commonly refers to
the consumption of five or more drinks by men or fouror more drinks by women over a period of about 2 h[21]. Since a standard drink is defined in Japan as 10 g ofpure alcohol, we defined binge drinking as consumptionof 50 g or more of alcohol by men and 40 g or more by
women in a 2-h period on one occasion within the pastmonth. Subjective view of health was one of the QOL
indices. In response to the question “What do you consider to be your usual health condition?” the participants
were asked to select one of four choices: “very healthy,”“fairly healthy,” “not so healthy,” and “not healthy.” The
AQoLS is a scale for the evaluation of the effects of alcohol on health-related QOL. We used the Japanese version of the AQoLS, which, like the original, consists of
34 scientifically verified questions. AUDIT is a screening
tool for alcohol use disorder developed by the WHO, andconsists of 10 questions, with a full score of 40 points.
As genetic information related to alcohol metabolism,
the gene activities of alcohol dehydrogenase 1B (ADH1B)
and aldehyde dehydrogenase 2 (ALDH2) were examined using a saliva test. ADH1B is one of the enzymes
that degrades ethanol, and ALDH2 is among those that
degrades acetaldehyde. Differences in their activities are
known to affect drinking behavior [22].
The drinking diary was designed in a calendar format,
in which the amount of alcoholic and non-alcoholic beverages consumed were to be entered under each date.
The drinking diary was provided to the study participants

Page 4 of 10

in printed form or in a Microsoft® Excel® file according
to their choice, and they were asked to submit it to thestudy secretariat once every 4 weeks, either in an e-mailattachment or by LINE® (whereby photos of the filledout diary were attached). For alcoholic beverages, participants were asked to specify the type, alcohol content, andthe amount of consumption in order to calculate alcohol
consumption, and the number of episodes of heavy episodic drinking (HED) was also counted. HED was definedas the consumption of at least 60 g of pure alcohol on atleast one occasion in the past 30 days [2].
Outcome

The primary endpoint was the change in total alcohol
consumption from baseline during the past 4 weeks at
Week 12 [23, 24]. Alcohol consumption (grams) was calculated based on the drinking diary data using the following formula: “consumption (mL) × alcohol concentration(%, v/v) × specific gravity (0.8)/100” [15]. In addition, thechange from baseline in the consumption of non-alcoholic beverages was calculated based on the amount (mL)of non-alcoholic beverages consumed as recorded in thedrinking diary. Furthermore, to examine whether alcohol
consumption was reduced by replacing alcoholic beverages with non-alcoholic ones, the correlation betweenchanges in alcohol consumption and the consumption of
non-alcoholic beverages was analyzed.
Sample size

The necessary sample size was calculated based on theeffect size of the change in alcohol consumption (Cohen’sd = 0.59, unpublished data) determined in a preliminary
investigation we performed by providing a brief intervention (a quick counseling by healthcare personnel) to
excessive drinkers and comparing the outcomes with acontrol group, with a significance level of 0.05 and a statistical power of 0.80. Forty-seven participants per group
and 94 in total (two groups) were determined to be necessary. Taking into consideration possible participant
dropout during the intervention period, approximately
25% of 94, i.e., 26, was added, and 120 was specified as
the target number of participants.
Randomization and blinding

A random number table was used to perform simple
randomization and to select the number of participantsin the intervention group. After the eligibility and exclusion criteria were confirmed and consent was obtained,
participants were allocated into either the intervention orcontrol group and notified of the randomization results
via e-mail within 2 weeks after the briefing. Allocation
was performed by Investigator K, without disclosing theallocation or its order to the other investigators. BecauseYoshimoto et al. BMC Medicine(2023) 21:379

people can choose their preferred non-alcoholic beverages in their everyday lives, and since the dropout rate
might be increased if participants were provided withbeverages that they did not like, those in the intervention
group were not blinded so that they could choose their
non-alcoholic beverages. For this reason, no items tofacilitate blinding were provided to the control group participants during the study, but instead non-alcoholic beverages were provided after the study period had ended.
The drinking diary data were evaluated by Investigators
K, S, and O, who were blinded to the allocations of participants in both groups. Investigator D was not involvedin briefings, randomization, questionnaire development,or the evaluation of drinking diary data, and therefore
was able to perform data analysis in a blinded manner.
Statistical methods

The available data of all participants were included
according to the original allocation in an intention-totreat analysis. The unsubmitted data of the participants
who dropped out were treated as missing data. The normality of the data was evaluated by the Kolmogorov–
Smirnov test. Intergroup comparisons of baseline data
were performed by t-test in cases of normal distribution
and by the Mann–Whitney U test in cases of non-normal
distribution. The chi-square test or Fisher’s exact probability test was performed for categorical variables. Twoway analysis of variance (ANOVA) was used to analyzechanges from baseline in the consumption of alcoholicand non-alcoholic beverages in the two groups, usinggroup and time as factors. Normality of the data was notobserved for either variable. However, homogeneity ofthe variance of the data was confirmed for both variables

Fig. 1 Study flow diagram

Page 5 of 10

using Levene’s test, and therefore, the results of the analysis of variance were accepted with reference to a preceding study (n = 121) [25].
As post hoc tests, Dunnett’s test was performed tocompare temporal sequences within the same group withreference to Week 4, and Bonferroni’s test was performed
to analyze intergroup differences at individual time
points. Correlations were evaluated based on Spearman’srank correlation coefficients. The significance level was
5%. Stata 17.0 for Windows (Stata Corp., College Station,
TX, USA) and GraphPad Prism v. 9.0 (GraphPad Inc., La
Jolla, CA, USA) were used for all analyses.

Results
The study flow chart is shown in Fig. 1. One hundred
twenty-three people wished to participate in the study
and all of them were randomized. Fifty-four (43.9%) wereallocated to the intervention group and 69 (56.1%) to thecontrol group. None of the participants in the intervention group dropped out, compared to two participants(1.6%) in the control group. One participant did not specify the reason for dropping out, while the other cited thehassle of filling out the drinking diary.
Table 2 and Table S1 show the basic attributes of all
123 participants. There were no significant differences
between the intervention and control groups in age (22to 72 years), sex, race, height, body weight, marital status,
highest level of education, employment status, householdincome, smoking history, AUDIT score, AQoLS score,
subjective view of health, or number of binge-drinking
episodes. Data on polymorphisms of the ADH1B and
ALDH2 genes, obtained from 122 participants, did not
differ significantly between the two groups (Table S2).

Yoshimoto et al. BMC Medicine(2023) 21:379

Page 6 of 10

Table 2 Characteristics in the participantsn = 123

Intervention groupn = 54(43.9%)

Control groupn = 69(56.1%)p

Age (years, SD)

47.5 (10.2)

47.8 (10.7)

47.2 (9.8)

0.74aFemale (number of participants, %)69 (56.1)

28 (51.9)

41 (59.4)

0.40b

Junior high school

1 (0.8)1 (1.9)0 (0.0)0.15c

High school

19 (15.5)

13 (24.1)

6 (8.7)

Vocational school

12 (9.8)

4 (7.4)8 (11.6)

Highest level of education (number of participants, %)Junior college, specialized vocational high school

17 (13.8)

6 (11.1)

11 (15.9)

College

50 (40.7)

22 (40.7)

28 (40.6)

24 (19.5)

8 (14.8)

16 (23.2)

AUDIT (points, median, IQR)

Graduate school

9.0 (7.0)

11.0 (7.0)

8.0 (7.0)

0.23d

Binge drinking (times/month, median, IQR)

4.0 (13.0)

4.0 (9.0)

3.0 (13.0)

0.53d

SD standard deviation, IQR interquartile rangeat-test, bChi-square test, cFisher’s exact probability test, dMann–Whitney U test

Alcohol consumption, the consumption of non-alcoholic beverages, and the number of instances of HED are
shown in Table 3 as baseline data. The median baseline
alcohol consumption was 996.0 g (interquartile range[IQR], 825.0) in the intervention group and 887.5 g (IQR,
765.0) in the control group, indicating no significant difference (p = 0.39).
The longitudinal changes in alcohol consumption
and non-alcoholic beverage consumption relative tobaseline at Weeks 4, 8, 12, 16, and 20 are presented
in Fig. 2. Two-way ANOVA of the change in alcohol
consumption using group and time as factors indicated a significant interaction (p = 0.040, η2 = 0.006,
Fig. 2A). The result of Bonferroni’s test for multiple
comparisons indicated significantly lower values in
the intervention group than in the control group at alltime points from Week 4 to Week 20 (p < 0.05 for all).
The main outcome in this study, the change in alcohol consumption at Week 12 (mean ± standard deviation), was − 320.8 ± 283.6 g in the intervention groupcompared with − 76.9 ± 272.6 g in the control group,
while that at Week 20 was − 276.9 ± 287.6 g in the intervention group compared with − 126.1 ± 338.4 g in thecontrol group. Neither group showed a significant effectof time on the change in alcohol consumption. Two-way
ANOVA of the change in consumption of non-alcoholic beverages also revealed a significant interaction(p < 0.001, η2 = 0.057, Fig. 2B). Bonferroni’s test for multiple comparisons indicated significantly higher values
in the intervention group than in the control group at
all time points from Week 4 to Week 20. Dunnett’s test
for multiple comparisons indicated no significant difference between Week 4 and Week 8 in the intervention group, but significantly lower values than those at
Week 4 were observed at each time point from Week 12
onward (p < 0.05 for all).
Spearman’s correlation coefficient was used to analyze each group in terms of the changes from baselinein both alcohol consumption and non-alcoholic beverage consumption at each time point from Week 4 toTable 3 Baseline alcoholic and non-alcoholic beverages consumption and the number of heavy episodic drinking
N = 122

Intervention group,
mediann = 54 (44.3%)

Control group, mediann = 68 (55.7%)pAlcohol consumption (g/4 weeks, IQR)

935.5 (771.0)

996.0 (825.0)

887.5 (765.0)

0.39d

Non-alcoholic beverage consumption(mL/4 weeks, IQR)

0.0 (350.0)

0.0 (700.0)

0.0 (0.0)

0.064dNumber of HED (times/4 weeks, IQR)

6.0 (12.0)

6.0 (16.0)

6.0 (11.0)

0.92d

HED heavy episodic drinking, IQR interquartile rangeat-test, bChi-square test, cFisher’s exact probability test, dMann–Whitney U testYoshimoto et al. BMC Medicine(2023) 21:379

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Fig. 2 Changes in alcoholic and non-alcoholic beverage consumption from baseline. A Alcohol consumption (interaction of group and time:
p = 0.040, η2 = 0.006; main effect of group: p < 0.001, η2 = 0.125; main effect of time: p = 0.846, η2 = 0.001). B Non-alcoholic beverage consumption(interaction of group and time: p < 0.001, η2 = 0.057; main effect of group: p < 0.001, η2 = 0.425; main effect of time: p < 0.001, η2 = 0.063). *p < 0.05 vs.
the control group at the same time point. †p < 0.05 vs. Week 4

Week 20. The main outcome, alcohol consumption at
Week 12, was not significantly correlated with nonalcoholic beverage consumption in the control group(ρ =  − 0.063, n = 67, p = 0.615). In contrast, a significant negative correlation was noted in the intervention
group (ρ =  − 0.500, n = 54, p < 0.001, Fig. 3) and was
also observed at Weeks 4, 8, and 16, with no significant
correlation at Week 20 (Fig. S1).
No adverse events were reported during the study.
The total cost of the non-alcoholic beverages provided
to the intervention group, including shipment costs,
was 1,061,564 yen (approximately 7820.6 US dollars),
which equated to a mean of 111.70 yen (approximately
0.82 US dollars) per 350-mL bottle.

Discussion
In this study, the provision of free non-alcoholic beverages for 12 weeks significantly reduced alcohol consumption. In the intervention group, this effect persisted
not only during the intervention period but also up to
8 weeks following completion of the 12-week intervention. Our study is the first to suggest that providing nonalcoholic beverages reduces alcohol consumption.
At Week 12, alcohol consumption was reduced by anaverage of 11.5 g per day. On the other hand, the average volume of non-alcoholic beverages consumed per
day was 314.3 mL. Correlation analysis showed a significant and moderate negative correlation between changes
from baseline in alcohol consumption and non-alcoholicFig. 3 Correlation between changes in alcohol consumption and non-alcoholic beverage consumption at Week 12 in the control and intervention
groups. A Control group (n = 67). B Intervention group (n = 54)

Yoshimoto et al. BMC Medicine(2023) 21:379

beverage consumption, but only in the intervention
group. This suggests that the reduced alcohol consumption in the intervention group may have been caused by
the replacement of alcoholic beverages with the provided
non-alcoholic beverages. A previous study demonstrated
that greater availability of non-alcoholic beverages
increased the odds of selecting non-alcoholic beverages
rather than alcoholic beverages [26]. In our study, thisincreased availability presumably resulted from the delivery of non-alcoholic beverages to participants’ homes. It
has been pointed out that replacing alcoholic with nonalcoholic beverages may lead to public health benefits[10], and therefore, such replacement may be effective as
one method for reducing the harmful impact of alcohol.
However, the correlation between the changes in alcohol consumption and non-alcoholic beverage consumption in the intervention group gradually weakened after
Week 8, and the significant correlation between themdisappeared at Week 20. Although the reason remains
unclear, it is possible that some of the non-alcoholic
beverages provided at Weeks 0, 4, and 8 were consumed
by the participants in the intervention group even after
Week 12. Thus, although the effect of replacing alcoholic
beverages lasted for a certain period, it was weakened
when all the available non-alcoholic beverages were consumed. While the participants were not restricted frompurchasing either alcoholic or non-alcoholic beverages
throughout the study period, we could not distinguishwhether the consumed non-alcoholic beverages were
provided or voluntarily purchased because our information from the participants pertained only to the consumption amount. Thus, further studies are warranted
to clarify this hypothesis. Nevertheless, the reductionof alcohol consumption in the intervention group was
not affected by time and was still observed at Week 20(8 weeks after completion of the intervention). This suggests that a certain degree of behavioral modification
may have occurred, in addition to the effect of replacing alcoholic with non-alcoholic beverages, and this may
have contributed to the persistent reduction in alcohol
consumption in the intervention group after the intervention was complete. As this study was not conductedin a blinded manner, the Hawthorne effect, which refers
to behavioral changes driven by attention or expectation from others, including investigators, may haveaffected the results [27]. However, no Hawthorne effectoccurred in a preceding study in which alcohol consumption data were collected by an online survey [28].
To prevent this effect as much as possible in the present
study, a 2-h face-to-face orientation session prior to randomization included a careful explanation that the effectof providing non-alcoholic beverages on alcohol consumption was unknown. We also asked participants inPage 8 of 10

both groups to go about their daily lives as usual, withthe exception of keeping a drinking diary. Finally, alcohol consumption and the consumption of non-alcoholic
beverages were reported using a messaging app online.
Given these measures, we consider it unlikely that the
Hawthorne affected the study results. As such, provisionof non-alcoholic beverages may be a new approach to
behavioral modification that facilitates reduced alcohol
consumption.
Although there was no significant difference in theintervention group between alcohol consumption
at Week 12 and that at Week 20, the mean value did
increase slightly, suggesting that the alcohol consumption-reducing effect of providing non-alcoholic beverages
did not persist long term after the intervention was complete. However, the reduction of alcohol consumption
over at least 20 weeks is considered beneficial in terms of
public health.
The control group in this study also exhibited reduced
alcohol consumption at Week 12, on average 2.7 g/day.
This change may have been caused by the requirement tokeep a drinking diary. According to a systematic review,
self-monitoring of substance use disorder was effective
in 29% of the analyzed studies, ineffective in 63%, andharmful in 8% [29]. Because people with alcoholism were
excluded from the present study, the drinking diary may
have effectively reduced alcohol consumption. Assumingthat the effect in the control group was the result of keeping a drinking diary, the decreased alcohol consumption observed in the intervention group is speculated toresult from the combination of providing non-alcoholic
beverages and keeping a drinking diary. For this reason,
it may be appropriate to estimate the alcohol consumption-reducing effect of providing non-alcoholic beverages to be 8.8 g/day (i.e., the observed 11.5-g reductionin this group minus the 2.7-g reduction in the control
group). The cost of the 12-week intervention required toreduce alcohol consumption by 8.8 g/day per person was
19,658.5 yen (approximately 144.8 US dollars; 1,061,564
yen divided by 54 [participants]). Because it has beensuggested that there is a negative association between
the price of non-alcoholic beverages and the numberof consumers of such beverages [30], a price increase islikely to result in fewer purchasers. Therefore, the resultsof this study, specifically the low dropout rate, may be
attributable to the fact that non-alcoholic beverages
were provided free of charge. Further research is necessary to determine how the results and dropout rate areaffected when participants are required to pay the costs
themselves.
Since the purpose of this study was to investigate
whether increased availability of non-alcoholic beverages would change the amount of alcohol consumption,

Yoshimoto et al. BMC Medicine(2023) 21:379

we first examined the effect of providing non-alcoholic
beverages purchased by the research group. The fact that
alcohol consumption decreased when these non-alcoholic beverages were provided to the participants indicates that this strategy may be useful as a public healthpolicy (e.g., providing price incentives for non-alcoholic
beverages) in the real world [3].
From a clinical point of view, it will be beneficial toexamine whether alcohol use changes if individuals purchase non-alcoholic beverages themselves. However, as
the non-alcoholic beverages delivered to the intervention
group were selected from a list specified by the participants based on their own preferences, we believe that thisstudy serves as a valuable foundation for future studies.
In this study, the number of participants differed
between the two groups because of simple randomization, but there was no significant bias in basic attributes
or baseline data, and the low percentage of dropouts(1.6%) contributed to the validity of the study. However,there are roughly five major limitations to this study.
The first is that almost all participants were Japanese,and therefore, caution should be exercised when generalizing the results across different races. Information was collected on alcohol metabolism-related genes
as well as on body size (height and body weight), andthese data are considered to be helpful for interpreting
the results of this study. The second limitation is thenarrowly defined target population in this study. Since
none of the participants had a history of alcoholism,
it remains unknown whether the results of this study
can be applied to individuals with alcoholism or thoseat high risk of other alcohol-related problems [20].
Therefore, future studies should examine the effect ofproviding non-alcoholic beverages to these populations, as well as the cost effectiveness of such programs. The third limitation is that the data on alcohol
consumption and non-alcoholic beverage consumption were reported by participants themselves. While
several objective blood biomarkers reflecting excessive
drinking exists, there are some problems, such as large
individual variation of the biomarkers and short halflife of them [31, 32]. Moreover, the longitudinal study
requires many times of blood collection, which canincrease drop-out our study. From these observations,
we used only diary to obtain the amount of drinking
alcoholic and non-alcoholic beverages. However, only
self-reported data were analyzed and interpreting theresults requires caution. The fourth limitation is that
this study was conducted in an open-label manner. In
this study, all participants were notified of their groupassignment 2 weeks before the start of the intervention,
due to the preparation time needed before providingthem with the non-alcohol beverages of their choice.

Page 9 of 10

Although none of the baseline data differed significantly between the two groups, revealing group assignments may have affected baseline values and the main
outcome of change in alcohol consumption. The last
limitation is that this study may have included unmeasurable confounding factors. Thus, future studies should
enroll larger populations.

Conclusions
Our results suggested that providing free non-alcoholic
beverages was associated with significantly reduced
alcohol consumption. This effect persisted for 8 weeks
after the completion of the intervention. Providing
non-alcoholic beverages may be a strategic option for
reducing alcohol consumption among people withexcessive drinking.
Abbreviations
ADH1B	Alcohol dehydrogenase 1B
ALDH2	Aldehyde dehydrogenase 2
ANOVA	Analysis of variance
AQoLS	Alcohol Quality of Life Scale
AUDIT	Alcohol Use Disorders Identification Test
COVID-19	Coronavirus disease 2019
HED	Heavy episodic drinkingWHO	World Health Organization

Supplementary Information
The online version contains supplementary material available at https://​doi.​
org/​10.​1186/​s12916-​023-​03085-1.
Additional file 1: Figure S1. Correlation between changes in alcohol
consumption and non-alcoholic beverage consumption at Weeks 4, 8, 16,
and 20 in the control and intervention groups. Panels A, C, E, and G indicate the relationships at Weeks 4, 8, 16, and 20, respectively, in the control
group (all panels, n = 67). Panels B, D, F, and H indicate the relationships at
Weeks 4, 8, 16, and 20, respectively, in the intervention group (all panels,
n = 54).
Additional file 2: Table S1. Characteristics in the participants other than
Table 1. Table S2. The number of populations of genetic polymorphisms
in ADH1B and ALDH2 in the participants.
Acknowledgements
The authors thank all participants in this study.
Authors’ contributions
H.Y. conceived and designed the study. H.Y., K.K., G.S., and Y.O. performed theintervention and data collection. S.D. analyzed the data. All authors interpreted the data. H.Y. and S.D. drafted the manuscript. S.D. prepared the tableand figures. K.K., G.S., and Y.O. revised it critically for important intellectual
content. All authors mentioned above made substantial contributions to thecontent of the paper. All authors read and approved the final manuscript.
Funding
This study was conducted jointly with Asahi Breweries, Ltd., which provided
funding.
Availability of data and materials
Not applicable.

Yoshimoto et al. BMC Medicine(2023) 21:379

Declarations
Ethics approval and consent to participate
This study was conducted after approval by the ethics committee of the University of Tsukuba (Notification Number G299) and written informed consent
was provided prior to participation.
Consent for publication
Not applicable.
Competing interests
H.Y. received research funding from Asahi Breweries. H.Y. also received themfrom Sanwa Shurui, which is not related to the conduct of our study. Studyplanning and conduct, data analysis, and writing of the manuscript were
performed only by the investigators, independently from the company, under
the supervision and instruction of the University of Tsukuba. Transparency andneutrality were strictly maintained during the conduct of the study. K.K., S.D.,
G.S., and Y.O. declare that they have no competing interests.
Author details
1
Research and Development Center for Lifestyle Innovation, Universityof Tsukuba, 1‑2 Kasuga, Tsukuba, Ibaraki 305‑8550, Japan. 2 Department
of Family Medicine, General Practice and Community Health, Institute of Medicine, University of Tsukuba, Tsukuba, Japan. 3 Department of Primary Careand Medical Education, Graduate School of Comprehensive Human Sciences,
University of Tsukuba, Tsukuba, Japan.
Received: 26 May 2023 Accepted: 20 September 2023

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