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

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hunan
      • Yongzhou, Hunan, China, 425300
        • Dao County People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Active Comparator: 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.

What is the study measuring?

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
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

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
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

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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Luke Law, Dr, OmniSolutions Laboratory Holdings Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2024

Primary Completion (Actual)

June 21, 2024

Study Completion (Actual)

June 21, 2024

Study Registration Dates

First Submitted

April 30, 2026

First Submitted That Met QC Criteria

May 6, 2026

First Posted (Actual)

May 14, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

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)?

NO

IPD Plan Description

Individual participant data will not be shared due to privacy protection and ethical considerations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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