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| ID | Type | Description | Link |
|---|---|---|---|
| 2024060001 | Other Identifier | Dao County People's Hospital Ethics Committee |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NatureU Cheers Friends Curcumin | Experimental | Participants received NatureU Cheers Friends Curcumin, three tablets orally 30 minutes before alcohol intake. |
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| Herbsense Hangover Relief Tablet | Active Comparator | Participants received Herbsense hangover relief tablets, two tablets orally 30 minutes before alcohol intake. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NatureU Cheers Friends Curcumin | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Acute Hangover Scale Total Score Between NatureU Cheers Friends Curcumin and Comparator Product | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Individual Acute Hangover Scale Item Scores Between NatureU Cheers Friends Curcumin and Comparator Product | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability During Test-Food Sessions | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luke Law, Dr | OmniSolutions Laboratory Holdings Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dao County People's Hospital | Yongzhou | Hunan | 425300 | China |
Individual participant data will not be shared due to privacy protection and ethical considerations.
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Participants completed two independent test-food sessions, one with the comparator product and one with NatureU Cheers Friends Curcumin, separated by at least 48 hours.
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The study was open-label with no masking.
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| Herbsense Hangover Relief Tablet | Dietary Supplement | The comparator product was Herbsense hangover relief tablet. Participants took two tablets 30 minutes before alcohol intake during the comparator session. |
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