UMIN-CTR Clinical Trial

Public title

Randomized controlled study on the impact of serving non-alcoholic beverages on alcohol consumption

Acronym

Randomized controlled study on the impact of serving non-alcoholic beverages on alcohol consumption

Scientific Title

Randomized controlled study on the impact of serving non-alcoholic beverages on alcohol consumption

Scientific Title:Acronym

Randomized controlled study on the impact of serving non-alcoholic beverages on alcohol consumption

Region

Japan

Condition

Excessive drinking that increases the risk of lifestyle-related diseases

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

Assess the impact of providing non-alcoholic beverages on the amount of alcohol consumed

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Changes in total alcohol intake for past 4 weeks from baseline (12 weeks after intervention)

Key secondary outcomes

1) Changes in total alcohol intake for past 4 weeks from baseline (4, 8, 16 and 20 weeks after intervention)
2) For past 4 weeks, number of days drank 60g or more for men and 40g or more for women, total alcohol intake (4, 8, 12, 16 and 20 weeks after intervention)
3) Alcohol Quality of Life Scale, subjective health perception and binge drinking (12 weeks and 20 weeks after intervention)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Provision of non-alcoholic beverages for 12 weeks
(3 times every 4 weeks, maximum quantity provided per 4weeks is 350ml/bottle x 24 bottles per case x 3 cases, each case selected from 22 types of non-alcoholic beverages from 4 manufacturers)

Interventions/Control_2

Control group: None

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.20 years and over
2.Drinkers who drink four days or more a week
3.Drinkers who drink 40g or more for men, 20g or more for women per day

Key exclusion criteria

1.Those who take non-alcoholic beverages twice a month or more
2.Those who have a history of liver disease
3.Pregnant / lactating
4.Alcohol dependence syndrome (diagnosed by interview with a doctor)
5.Disagreement with the use of LINE

Target sample size

120

Name of lead principal investigator

1st name	Hisashi
Middle name
Last name	Yoshimoto

Organization

University of Tsukuba

Division name

R&D Center for Lifestyle Innovation

Zip code

305-8550

Address

1-2 Kasuga, Tsukuba 305-8550

TEL

029-853-1019

Email

hisashiyoshi@md.tsukuba.ac.jp

Name of contact person

1st name	Kyoko
Middle name
Last name	Kawaida

Organization

University of Tsukuba

Division name

R&D Center for Lifestyle Innovation

Zip code

305-8550

Address

1-2 Kasuga, Tsukuba 305-8550

TEL

029-853-1019

Homepage URL

Email

kawaida.kyoko.ff@u.tsukuba.ac.jp

Institute

University of Tsukuba, R&D Center for Lifestyle Innovation

Institute

Department

Personal name

Organization

ASAHI BREWERIES, LTD.

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

University of Tsukuba

Address

1-1-1 Tennodai, Tsukuba 305-8575

Tel

029-853-3022

Email

sien.ningenss@un.tsukuba.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

06

Month

04

Day

URL releasing protocol

https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-023-03085-1

Publication of results

Partially published

URL related to results and publications

https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-023-03085-1

Number of participants that the trial has enrolled

123

Results

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).

Results date posted

2024

Year

04

Month

19

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

With reference to preceding studies [14, 15], the eligibility criteria for participants in this study were specified as follows: (1) at least 20 years of age and (2) drinking on 4 or more days per week, with alcohol consumption of at least 40 g for men or 20 g for women on each of the days. The exclusion criteria were consumption of non-alcoholic beverages at least twice per month, past history of 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., Shinjuku-ku, Tokyo, Japan), and inability to understand the study explanation or answer the online survey conducted in advance, 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 the desire to drink, which may increase the risk of drinking relapse [16].

Participant flow

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 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 advance to confirm eligibility and exclusion criteria, as well as to participate 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 the number of attendees at each meeting was restricted to 15 as a COVID-19 prevention measure. In addition to interviews for alcoholism with physicians, measurement of height and weight and collection of saliva samples, this 2-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.The study procedures are described in Table 1. Week 0 of the study was defined as the start of the intervention. In the preparation period, the number of weeks was counted 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 to initially confirm eligibility criteria. Two physicians were in charge of interviews. Each individual was interviewed 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 to assess 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 the end 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.During the 12-week intervention period, free non-alcoholic beverages were provided once every 4 weeks (three times 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 participants preference. Participants selected beverages from among 22 products from four manufacturers, specifically the six top-ranked beer-flavored products and the 16 top-ranked cocktail-flavored products according to the sales ranking in the Japanese market in 2021. The selected non-alcoholic beverages were shipped to participants homes by a package delivery company.

Adverse events

There were no reports of adverse events during the study.

Outcome measures

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 four or more drinks by women over a period of about 2h [21]. Since a standard drink is defined in Japan as 10 g of pure alcohol, we defined binge drinking as consumption of 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 past month. 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, and consists 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 in printed form or in a Microsoft Excel file according to their choice, and they were asked to submit it to the study secretariat once every 4 weeks, either in an e-mail attachment or by LINE (whereby photos of the filled-out diary were attached). For alcoholic beverages, participants were asked to specify the type, alcohol content, and the amount of consumption in order to calculate alcohol consumption, and the number of episodes of heavy episodic drinking (HED) was also counted. HED was defined as the consumption of at least 60 g of pure alcohol on at least one occasion in the past 30 days [2].

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2022

Year

03

Month

31

Day

Date of IRB

2022

Year

04

Month

15

Day

Anticipated trial start date

2022

Year

06

Month

05

Day

Last follow-up date

2023

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

06

Month

04

Day

Last modified on

2024

Year

04

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054615