A Crossover Exploratory Study of NatureU Cheers Friends Curcumin on Acute Alcohol Hangover Symptoms (NUZY)
A Single-Center, Open-Label, Crossover Exploratory Study of NatureU Cheers Friends Curcumin on Acute Alcohol Hangover Symptoms in Healthy Adult Men
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Hunan
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Yongzhou, Hunan, China, 425300
- Dao County People's Hospital
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: NatureU Cheers Friends Curcumin
Participants received NatureU Cheers Friends Curcumin, three tablets orally 30 minutes before alcohol intake.
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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.
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Active Comparator: Herbsense Hangover Relief Tablet
Participants received Herbsense hangover relief tablets, two tablets orally 30 minutes before alcohol intake.
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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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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in Acute Hangover Scale Total Score Between NatureU Cheers Friends Curcumin and Comparator Product
Time Frame: 12 hours after alcohol intake in each test-food session
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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.
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12 hours after alcohol intake in each test-food session
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in Individual Acute Hangover Scale Item Scores Between NatureU Cheers Friends Curcumin and Comparator Product
Time Frame: 12 hours after alcohol intake in each test-food session
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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.
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12 hours after alcohol intake in each test-food session
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Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety and Tolerability During Test-Food Sessions
Time Frame: Baseline, 30 minutes, 60 minutes, and 120 minutes after alcohol intake during each test session
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Safety monitoring included participant status and vital sign assessments, including blood pressure and pulse rate, during the supervised test procedures.
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Baseline, 30 minutes, 60 minutes, and 120 minutes after alcohol intake during each test session
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Luke Law, Dr, OmniSolutions Laboratory Holdings Limited
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
Other Study ID Numbers
- 2024060001 (Other Identifier: Dao County People's Hospital Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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