A Crossover Exploratory Study of NatureU Cheers Friends Curcumin on Acute Alcohol Hangover Symptoms (NUZY)
2026年5月6日 更新者：OmniSolutions Laboratory Holdings Limited
A Single-Center, Open-Label, Crossover Exploratory Study of NatureU Cheers Friends Curcumin on Acute Alcohol Hangover Symptoms in Healthy Adult Men
This was a single-center, open-label, exploratory crossover study evaluating acute hangover symptoms after use of NatureU Cheers Friends Curcumin compared with an active comparator product in healthy adult men.
Participants completed two independent test-food sessions separated by at least 48 hours.
Sixteen participants were recruited, 12 were screened and enrolled, and 12 were included in the effectiveness analysis.
In the control session, participants took Herbsense hangover relief tablets 30 minutes before alcohol intake.
In the NatureU Cheers Friends Curcumin session, participants took NatureU Cheers Friends Curcumin 30 minutes before alcohol intake.
The main outcome was the Acute Hangover Scale (AHS) assessed the morning after each test session.
Safety was monitored during the test procedures.
調査の概要
状態
完了
詳細な説明
The study was designed as an exploratory human evaluation of a functional food product intended to support post-alcohol hangover relief.
Eligible healthy adult male participants completed two independent test-food sessions under researcher supervision.
Screening was performed on June 19, 2024, eligible participants were enrolled on June 20, 2024, and the final next-morning questionnaire assessment was completed on June 21, 2024.
Participants were instructed not to drink alcohol for 24 hours before each test day and not to eat during the 3 hours before testing.
On each test day, participants arrived at the study center at approximately 18:00, completed check-in and baseline assessments including blood pressure, pulse rate, and breath alcohol measurement, and received the assigned test product at approximately 18:30.
At approximately 19:00, participants consumed 100 mL of commercially available 52% Chinese baijiu within 10-15 minutes and consumed a standardized meal within 30 minutes.
Blood pressure and pulse rate were measured 30, 60, and 120 minutes after alcohol intake.
Participants completed the Acute Hangover Scale the next morning after waking.
The study was open-label and exploratory, with no masking.
Analyses compared AHS scores after NatureU Cheers Friends Curcumin with scores after the comparator product.
研究の種類
介入
入学 (実際)
12
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Hunan
-
Yongzhou、Hunan、中国、425300
- Dao County People's Hospital
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- Signed informed consent before the study and understood the study content, procedures, and possible adverse reactions.
- Healthy adult man aged 20 to 48 years, inclusive.
- Normal social drinking lifestyle and no alcohol dependence.
- Aspartate aminotransferase and alanine aminotransferase values within two standard deviations of the normal range.
- Able to maintain normal healthy routines during the study.
- Able to avoid other interfering supplements for 2 weeks before and during the study.
- Abstained from alcohol for 24 hours before the study.
- Abstained from caffeinated beverages, including coffee, tea, and energy drinks, for 12 hours before the study.
Exclusion Criteria:
- Known allergy or hypersensitivity to product ingredients, including magnolia bark, milk thistle extract, turmeric, or alcohol.
- History of multiple drug or food allergies.
- Acute or chronic inflammatory disease, including influenza A, within the previous month.
- Hypertension.
- Participation in any other clinical trial within 1 month before first use of the study product.
- Clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immune, psychiatric, cardiovascular, cerebrovascular, or metabolic disease within the previous 6 months.
- Acute illness or concomitant medication use from screening to first use of the study product.
- Surgery within the previous 3 months.
- Blood donation or major blood loss greater than 450 mL within the previous 3 months.
- Difficulty swallowing.
- Use of prescription or non-prescription medications affecting nutritional supplements or alcohol metabolism.
- Any other factor judged by the investigator to make participation inappropriate.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：非ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：NatureU Cheers Friends Curcumin
Participants received NatureU Cheers Friends Curcumin, three tablets orally 30 minutes before alcohol intake.
|
NatureU Cheers Friends Curcumin is an oral functional food product containing magnolia bark extract, milk thistle extract, high-concentration turmeric, and related ingredients.
Participants took three tablets 30 minutes before alcohol intake.
|
|
アクティブコンパレータ：Herbsense Hangover Relief Tablet
Participants received Herbsense hangover relief tablets, two tablets orally 30 minutes before alcohol intake.
|
The comparator product was Herbsense hangover relief tablet.
Participants took two tablets 30 minutes before alcohol intake during the comparator session.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Difference in Acute Hangover Scale Total Score Between NatureU Cheers Friends Curcumin and Comparator Product
時間枠：12 hours after alcohol intake in each test-food session
|
The Acute Hangover Scale includes nine items scored from 0 to 7, with higher scores indicating more severe hangover symptoms.
The primary endpoint was the difference in total AHS score after NatureU Cheers Friends Curcumin compared with the comparator product.
|
12 hours after alcohol intake in each test-food session
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Difference in Individual Acute Hangover Scale Item Scores Between NatureU Cheers Friends Curcumin and Comparator Product
時間枠：12 hours after alcohol intake in each test-food session
|
Individual AHS item scores included hangover, thirst, fatigue, headache, dizziness, appetite loss, stomachache, nausea, and heart racing.
Each item was scored from 0 to 7, with higher scores indicating more severe symptoms.
|
12 hours after alcohol intake in each test-food session
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Safety and Tolerability During Test-Food Sessions
時間枠：Baseline, 30 minutes, 60 minutes, and 120 minutes after alcohol intake during each test session
|
Safety monitoring included participant status and vital sign assessments, including blood pressure and pulse rate, during the supervised test procedures.
|
Baseline, 30 minutes, 60 minutes, and 120 minutes after alcohol intake during each test session
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディディレクター：Luke Law, Dr、OmniSolutions Laboratory Holdings Limited
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年6月20日
一次修了 (実際)
2024年6月21日
研究の完了 (実際)
2024年6月21日
試験登録日
最初に提出
2026年4月30日
QC基準を満たした最初の提出物
2026年5月6日
最初の投稿 (実際)
2026年5月14日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月14日
QC基準を満たした最後の更新が送信されました
2026年5月6日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 2024060001 (その他の識別子：Dao County People's Hospital Ethics Committee)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
Individual participant data will not be shared due to privacy protection and ethical considerations.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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