UMIN-CTR 臨床試験登録情報の閲覧

一般向け試験名/Public title

日本語
職域でのノンアルコール提供前後における飲酒関連指標の変化の要因：パイロット研究

英語
Factors for Changes in Alcohol-Related Indicators Due to Non-Alcoholic Beverage Provision in the Workplace: A Pilot Study

一般向け試験名略称/Acronym

日本語
職域でのノンアルコール提供前後における飲酒関連指標の変化の要因：パイロット研究

英語
Factors for Changes in Alcohol-Related Indicators Due to Non-Alcoholic Beverage Provision in the Workplace: A Pilot Study

科学的試験名/Scientific Title

日本語
職域でのノンアルコール提供前後における飲酒関連指標の変化の要因：パイロット研究

英語
Factors for Changes in Alcohol-Related Indicators Due to Non-Alcoholic Beverage Provision in the Workplace: A Pilot Study

科学的試験名略称/Scientific Title:Acronym

日本語
職域でのノンアルコール提供前後における飲酒関連指標の変化の要因：パイロット研究

英語
Factors for Changes in Alcohol-Related Indicators Due to Non-Alcoholic Beverage Provision in the Workplace: A Pilot Study

試験実施地域/Region

日本/Japan

対象疾患名/Condition

日本語
生活習慣病のリスクを高める過剰な飲酒

英語
Excessive drinking that increases the risk of lifestyle-related diseases

疾患区分1/Classification by specialty

成人/Adult

疾患区分2/Classification by malignancy

悪性腫瘍以外/Others

ゲノム情報の取扱い/Genomic information

いいえ/NO

目的1/Narrative objectives1

日本語
ノンアルコール飲料の提供による飲酒量への影響と、飲酒量へ影響を与える様々な要因について調査する

英語
To conduct a study investigating the impact of non-alcoholic beverage provision on alcohol consumption levels and identify the various factors that influence drinking behaviors

目的2/Basic objectives2

有効性/Efficacy

目的2 -その他詳細/Basic objectives -Others

日本語

英語

試験の性質1/Trial characteristics_1

試験の性質2/Trial characteristics_2

試験のフェーズ/Developmental phase

主要アウトカム評価項目/Primary outcomes

日本語
過去3週間の総アルコール摂取量

英語
Total alcohol intake for past 3 weeks from baseline (3 weeks after intervention)

副次アウトカム評価項目/Key secondary outcomes

日本語
過去3週間の総アルコール摂取量、ノンアルコール摂取量とアルコール摂取量の相関、HDD（男性で60g、女性で40g以上摂取した日数）、一時多量飲酒HED、ビンジ飲酒

英語
Correlation Between Non-Alcoholic and Alcoholic Beverage Consumption, Total Alcohol Intake, Heavy Drinking Days, Heavy Episodic Drinking, and Binge Drinking Patterns Over Three Weeks

試験の種類/Study type

介入/Interventional

基本デザイン/Basic design

単群/Single arm

ランダム化/Randomization

非ランダム化/Non-randomized

ランダム化の単位/Randomization unit

ブラインド化/Blinding

オープン/Open -no one is blinded

コントロール/Control

無対照/Uncontrolled

層別化/Stratification

動的割付/Dynamic allocation

試験実施施設の考慮/Institution consideration

ブロック化/Blocking

割付コードを知る方法/Concealment

群数/No. of arms

1

介入の目的/Purpose of intervention

治療・ケア/Treatment

介入の種類/Type of intervention

食品/Food

介入1/Interventions/Control_1

日本語
3週間のノンアルコール飲料の提供

英語
Provision of non-alcoholic beverages for 3 weeks

介入2/Interventions/Control_2

日本語

英語

介入3/Interventions/Control_3

日本語

英語

介入4/Interventions/Control_4

日本語

英語

介入5/Interventions/Control_5

日本語

英語

介入6/Interventions/Control_6

日本語

英語

介入7/Interventions/Control_7

日本語

英語

介入8/Interventions/Control_8

日本語

英語

介入9/Interventions/Control_9

日本語

英語

介入10/Interventions/Control_10

日本語

英語

年齢（下限）/Age-lower limit

20

歳/years-old

以上/<=

年齢（上限）/Age-upper limit

適用なし/Not applicable

性別/Gender

男女両方/Male and Female

選択基準/Key inclusion criteria

日本語
平均４回／週以上飲酒しており、1回飲酒量が男性で40ｇ以上、女性で20ｇ以上のもの

英語
1.Drinkers who drink four days or more a week
2.Drinkers who drink 40g or more for men, 20g or more for women per day

除外基準/Key exclusion criteria

日本語
１．妊娠中の方・授乳中である方
２．アルコール依存症の方

英語
1.Pregnant / lactating
2.Alcohol dependence syndrome

目標参加者数/Target sample size

40

責任研究者/Name of lead principal investigator

日本語

名	尚
ミドルネーム
姓	吉本

英語

名	Hisashi
ミドルネーム
姓	Yoshimoto

所属組織/Organization

日本語
筑波大学

英語
University of Tsukuba

所属部署/Division name

日本語
健幸ライフスタイル開発研究センター

英語
R&D Center for Lifestyle Innovation

郵便番号/Zip code

305-8550

住所/Address

日本語
茨城県つくば市春日1-2

英語
1-2 Kasuga, Tsukuba 305-8550

電話/TEL

029-853-1019

Email/Email

hisashiyoshi@md.tsukuba.ac.jp

試験問い合わせ窓口担当者/Name of contact person

日本語

名	歩惟
ミドルネーム
姓	大畑

英語

名	Ai
ミドルネーム
姓	Ohata

組織名/Organization

日本語
筑波大学

英語
University of Tsukuba

部署名/Division name

日本語
健幸ライフスタイル開発研究センター

英語
R&D Center for Lifestyle Innovation

郵便番号/Zip code

305-8550

住所/Address

日本語
茨城県つくば市春日1-2

英語
1-2 Kasuga, Tsukuba

電話/TEL

029-853-1019

試験のホームページURL/Homepage URL

Email/Email

lifestyle-tsukuba@un.tsukuba.ac.jp

機関名/Institute

日本語
その他

英語
University of Tsukuba, R&D Center for Lifestyle Innovation

機関名/Institute
（機関選択不可の場合）

日本語
筑波大学

部署名/Department

日本語

個人名/Personal name

日本語

英語

機関名/Organization

日本語
その他

英語
ASAHI BREWERIES, LTD.

機関名/Organization
（機関選択不可の場合）

日本語
アサヒビール株式会社

組織名/Division

日本語

組織の区分/Category of Funding Organization

営利企業/Profit organization

研究費拠出国/Nationality of Funding Organization

日本語

英語

共同実施組織/Co-sponsor

日本語

英語

その他の研究費提供組織/Name of secondary funder(s)

日本語

英語

組織名/Organization

日本語
筑波大学

英語
University of Tsukuba

住所/Address

日本語
茨城県つくば市天王台1-1-1

英語
1-1-1 Tennodai, Tsukuba 305-8575

電話/Tel

029-853-3022

Email/Email

sien.ningenss@un.tsukuba.ac.jp

他機関から発行された試験ID/Secondary IDs

いいえ/NO

試験ID1/Study ID_1

ID発行機関1/Org. issuing International ID_1

日本語

英語

試験ID2/Study ID_2

ID発行機関2/Org. issuing International ID_2

日本語

英語

治験届/IND to MHLW

試験実施施設名称/Institutions

一般公開日（本登録希望日）/Date of disclosure of the study information

2023

年

12

月

31

日

プロトコル掲載URL/URL releasing protocol

https://www.cell.com/heliyon/fulltext/S2405-8440(26)00020-4

試験結果の公開状況/Publication of results

最終結果が公表されている/Published

結果掲載URL/URL related to results and publications

https://www.cell.com/heliyon/fulltext/S2405-8440(26)00020-4

組み入れ参加者数/Number of participants that the trial has enrolled

24

主な結果/Results

日本語
Alcohol consumption was significantly reduced three weeks after the intervention compared to before the intervention (-9.8 g/day, p < 0.01), but this significant reduction in alcohol consumption disappeared six weeks after the intervention (-5.9 g/day, p = 0.057). Non-alcoholic beverage consumption increased three weeks after the intervention (p < 0.01), and this significant increase was maintained even six weeks after the intervention (p < 0.01, Fig. 1B).

英語
Alcohol consumption was significantly reduced three weeks after the intervention compared to before the intervention (-9.8 g/day, p < 0.01), but this significant reduction in alcohol consumption disappeared six weeks after the intervention (-5.9 g/day, p = 0.057). Non-alcoholic beverage consumption increased three weeks after the intervention (p < 0.01), and this significant increase was maintained even six weeks after the intervention (p < 0.01, Fig. 1B).

主な結果入力日/Results date posted

2026

年

02

月

09

日

結果掲載遅延/Results Delayed

結果遅延理由/Results Delay Reason

日本語

英語

最初の試験結果の出版日/Date of the first journal publication of results

2026

年

01

月

15

日

参加者背景/Baseline Characteristics

日本語
Our previous study demonstrated that providing three cases of non-alcoholic beverages on separate occasions significantly reduced alcohol consumption among heavy drinkers. However, interventions with reduced costs are required, particularly for health promotion in the workplace. Therefore, we investigated whether a single provision of one case of non-alcoholic beverages could reduce alcohol consumption among workers who drink heavily. This was a single-center, open-label, single-arm study. Participants aged 20 years or older who usually drink heavily but were not diagnosed with alcohol dependence were recruited. Each participant received one case of free non-alcoholic beverages (twenty-four 350 mL cans). From three weeks before to six weeks after the provision of non-alcoholic beverages, the consumption of alcoholic and non-alcoholic beverages was recorded in a drinking diary. Twenty-four individuals participated in this study, one of whom dropped out. Changes in alcohol consumption were analyzed using repeated measures analysis of variance and within-individual associations with non-alcoholic beverage consumption were examined using repeated measures correlation. Alcohol consumption significantly decreased three weeks after the intervention compared to baseline, but this effect was no longer evident at six weeks after the intervention. The reduction in alcohol consumption was associated with the replacement of non-alcoholic beverages without changes in the total intake of alcoholic and non-alcoholic beverages. These findings demonstrate that even a one-time provision of non-alcoholic beverages may be an effective, scalable strategy to reduce alcohol consumption among heavy-drinking workers.

英語
Our previous study demonstrated that providing three cases of non-alcoholic beverages on separate occasions significantly reduced alcohol consumption among heavy drinkers. However, interventions with reduced costs are required, particularly for health promotion in the workplace. Therefore, we investigated whether a single provision of one case of non-alcoholic beverages could reduce alcohol consumption among workers who drink heavily. This was a single-center, open-label, single-arm study. Participants aged 20 years or older who usually drink heavily but were not diagnosed with alcohol dependence were recruited. Each participant received one case of free non-alcoholic beverages (twenty-four 350 mL cans). From three weeks before to six weeks after the provision of non-alcoholic beverages, the consumption of alcoholic and non-alcoholic beverages was recorded in a drinking diary. Twenty-four individuals participated in this study, one of whom dropped out. Changes in alcohol consumption were analyzed using repeated measures analysis of variance and within-individual associations with non-alcoholic beverage consumption were examined using repeated measures correlation. Alcohol consumption significantly decreased three weeks after the intervention compared to baseline, but this effect was no longer evident at six weeks after the intervention. The reduction in alcohol consumption was associated with the replacement of non-alcoholic beverages without changes in the total intake of alcoholic and non-alcoholic beverages. These findings demonstrate that even a one-time provision of non-alcoholic beverages may be an effective, scalable strategy to reduce alcohol consumption among heavy-drinking workers.

参加者の流れ/Participant flow

日本語
Our previous study demonstrated that providing three cases of non-alcoholic beverages on separate occasions significantly reduced alcohol consumption among heavy drinkers. However, interventions with reduced costs are required, particularly for health promotion in the workplace. Therefore, we investigated whether a single provision of one case of non-alcoholic beverages could reduce alcohol consumption among workers who drink heavily. This was a single-center, open-label, single-arm study. Participants aged 20 years or older who usually drink heavily but were not diagnosed with alcohol dependence were recruited. Each participant received one case of free non-alcoholic beverages (twenty-four 350 mL cans). From three weeks before to six weeks after the provision of non-alcoholic beverages, the consumption of alcoholic and non-alcoholic beverages was recorded in a drinking diary. Twenty-four individuals participated in this study, one of whom dropped out. Changes in alcohol consumption were analyzed using repeated measures analysis of variance and within-individual associations with non-alcoholic beverage consumption were examined using repeated measures correlation. Alcohol consumption significantly decreased three weeks after the intervention compared to baseline, but this effect was no longer evident at six weeks after the intervention. The reduction in alcohol consumption was associated with the replacement of non-alcoholic beverages without changes in the total intake of alcoholic and non-alcoholic beverages. These findings demonstrate that even a one-time provision of non-alcoholic beverages may be an effective, scalable strategy to reduce alcohol consumption among heavy-drinking workers.

英語
Our previous study demonstrated that providing three cases of non-alcoholic beverages on separate occasions significantly reduced alcohol consumption among heavy drinkers. However, interventions with reduced costs are required, particularly for health promotion in the workplace. Therefore, we investigated whether a single provision of one case of non-alcoholic beverages could reduce alcohol consumption among workers who drink heavily. This was a single-center, open-label, single-arm study. Participants aged 20 years or older who usually drink heavily but were not diagnosed with alcohol dependence were recruited. Each participant received one case of free non-alcoholic beverages (twenty-four 350 mL cans). From three weeks before to six weeks after the provision of non-alcoholic beverages, the consumption of alcoholic and non-alcoholic beverages was recorded in a drinking diary. Twenty-four individuals participated in this study, one of whom dropped out. Changes in alcohol consumption were analyzed using repeated measures analysis of variance and within-individual associations with non-alcoholic beverage consumption were examined using repeated measures correlation. Alcohol consumption significantly decreased three weeks after the intervention compared to baseline, but this effect was no longer evident at six weeks after the intervention. The reduction in alcohol consumption was associated with the replacement of non-alcoholic beverages without changes in the total intake of alcoholic and non-alcoholic beverages. These findings demonstrate that even a one-time provision of non-alcoholic beverages may be an effective, scalable strategy to reduce alcohol consumption among heavy-drinking workers.

有害事象/Adverse events

日本語
Our previous study demonstrated that providing three cases of non-alcoholic beverages on separate occasions significantly reduced alcohol consumption among heavy drinkers. However, interventions with reduced costs are required, particularly for health promotion in the workplace. Therefore, we investigated whether a single provision of one case of non-alcoholic beverages could reduce alcohol consumption among workers who drink heavily. This was a single-center, open-label, single-arm study. Participants aged 20 years or older who usually drink heavily but were not diagnosed with alcohol dependence were recruited. Each participant received one case of free non-alcoholic beverages (twenty-four 350 mL cans). From three weeks before to six weeks after the provision of non-alcoholic beverages, the consumption of alcoholic and non-alcoholic beverages was recorded in a drinking diary. Twenty-four individuals participated in this study, one of whom dropped out. Changes in alcohol consumption were analyzed using repeated measures analysis of variance and within-individual associations with non-alcoholic beverage consumption were examined using repeated measures correlation. Alcohol consumption significantly decreased three weeks after the intervention compared to baseline, but this effect was no longer evident at six weeks after the intervention. The reduction in alcohol consumption was associated with the replacement of non-alcoholic beverages without changes in the total intake of alcoholic and non-alcoholic beverages. These findings demonstrate that even a one-time provision of non-alcoholic beverages may be an effective, scalable strategy to reduce alcohol consumption among heavy-drinking workers.

英語
Our previous study demonstrated that providing three cases of non-alcoholic beverages on separate occasions significantly reduced alcohol consumption among heavy drinkers. However, interventions with reduced costs are required, particularly for health promotion in the workplace. Therefore, we investigated whether a single provision of one case of non-alcoholic beverages could reduce alcohol consumption among workers who drink heavily. This was a single-center, open-label, single-arm study. Participants aged 20 years or older who usually drink heavily but were not diagnosed with alcohol dependence were recruited. Each participant received one case of free non-alcoholic beverages (twenty-four 350 mL cans). From three weeks before to six weeks after the provision of non-alcoholic beverages, the consumption of alcoholic and non-alcoholic beverages was recorded in a drinking diary. Twenty-four individuals participated in this study, one of whom dropped out. Changes in alcohol consumption were analyzed using repeated measures analysis of variance and within-individual associations with non-alcoholic beverage consumption were examined using repeated measures correlation. Alcohol consumption significantly decreased three weeks after the intervention compared to baseline, but this effect was no longer evident at six weeks after the intervention. The reduction in alcohol consumption was associated with the replacement of non-alcoholic beverages without changes in the total intake of alcoholic and non-alcoholic beverages. These findings demonstrate that even a one-time provision of non-alcoholic beverages may be an effective, scalable strategy to reduce alcohol consumption among heavy-drinking workers.

評価項目/Outcome measures

日本語
Our previous study demonstrated that providing three cases of non-alcoholic beverages on separate occasions significantly reduced alcohol consumption among heavy drinkers. However, interventions with reduced costs are required, particularly for health promotion in the workplace. Therefore, we investigated whether a single provision of one case of non-alcoholic beverages could reduce alcohol consumption among workers who drink heavily. This was a single-center, open-label, single-arm study. Participants aged 20 years or older who usually drink heavily but were not diagnosed with alcohol dependence were recruited. Each participant received one case of free non-alcoholic beverages (twenty-four 350 mL cans). From three weeks before to six weeks after the provision of non-alcoholic beverages, the consumption of alcoholic and non-alcoholic beverages was recorded in a drinking diary. Twenty-four individuals participated in this study, one of whom dropped out. Changes in alcohol consumption were analyzed using repeated measures analysis of variance and within-individual associations with non-alcoholic beverage consumption were examined using repeated measures correlation. Alcohol consumption significantly decreased three weeks after the intervention compared to baseline, but this effect was no longer evident at six weeks after the intervention. The reduction in alcohol consumption was associated with the replacement of non-alcoholic beverages without changes in the total intake of alcoholic and non-alcoholic beverages. These findings demonstrate that even a one-time provision of non-alcoholic beverages may be an effective, scalable strategy to reduce alcohol consumption among heavy-drinking workers.

英語
Our previous study demonstrated that providing three cases of non-alcoholic beverages on separate occasions significantly reduced alcohol consumption among heavy drinkers. However, interventions with reduced costs are required, particularly for health promotion in the workplace. Therefore, we investigated whether a single provision of one case of non-alcoholic beverages could reduce alcohol consumption among workers who drink heavily. This was a single-center, open-label, single-arm study. Participants aged 20 years or older who usually drink heavily but were not diagnosed with alcohol dependence were recruited. Each participant received one case of free non-alcoholic beverages (twenty-four 350 mL cans). From three weeks before to six weeks after the provision of non-alcoholic beverages, the consumption of alcoholic and non-alcoholic beverages was recorded in a drinking diary. Twenty-four individuals participated in this study, one of whom dropped out. Changes in alcohol consumption were analyzed using repeated measures analysis of variance and within-individual associations with non-alcoholic beverage consumption were examined using repeated measures correlation. Alcohol consumption significantly decreased three weeks after the intervention compared to baseline, but this effect was no longer evident at six weeks after the intervention. The reduction in alcohol consumption was associated with the replacement of non-alcoholic beverages without changes in the total intake of alcoholic and non-alcoholic beverages. These findings demonstrate that even a one-time provision of non-alcoholic beverages may be an effective, scalable strategy to reduce alcohol consumption among heavy-drinking workers.

個別症例データ共有計画/Plan to share IPD

日本語

英語

個別症例データ共有計画の詳細/IPD sharing Plan description

日本語

英語

試験進捗状況/Recruitment status

主たる結果の公表済み/Main results already published

プロトコル確定日/Date of protocol fixation

2023

年

10

月

02

日

倫理委員会による承認日/Date of IRB

2023

年

10

月

31

日

登録・組入れ開始（予定）日/Anticipated trial start date

2023

年

11

月

07

日

フォロー終了(予定)日/Last follow-up date

2024

年

03

月

31

日

入力終了(予定)日/Date of closure to data entry

データ固定（予定）日/Date trial data considered complete

解析終了(予定)日/Date analysis concluded

その他関連情報/Other related information

日本語

英語

登録日時/Registered date

2023

年

11

月

06

日

最終更新日/Last modified on

2026

年

02

月

09

日

閲覧ページへのリンク/Link to view the page

日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000060146

英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060146