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A Crossover Exploratory Study of NatureU Cheers Friends Curcumin on Acute Alcohol Hangover Symptoms (NUZY)

6 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

12

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: NatureU Cheers Friends Curcumin
Participants received NatureU Cheers Friends Curcumin, three tablets orally 30 minutes before alcohol intake.
Voedingssupplement: NatureU Cheers Friends Curcumin
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.
Actieve vergelijker: Herbsense Hangover Relief Tablet
Participants received Herbsense hangover relief tablets, two tablets orally 30 minutes before alcohol intake.
Voedingssupplement: Herbsense Hangover Relief Tablet
The comparator product was Herbsense hangover relief tablet. Participants took two tablets 30 minutes before alcohol intake during the comparator session.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Difference in Acute Hangover Scale Total Score Between NatureU Cheers Friends Curcumin and Comparator Product
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Difference in Individual Acute Hangover Scale Item Scores Between NatureU Cheers Friends Curcumin and Comparator Product
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Safety and Tolerability During Test-Food Sessions
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

OmniSolutions Laboratory Holdings Limited

Onderzoekers

  • Studie directeur: Luke Law, Dr, OmniSolutions Laboratory Holdings Limited

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

20 juni 2024

Primaire voltooiing (Werkelijk)

21 juni 2024

Studie voltooiing (Werkelijk)

21 juni 2024

Studieregistratiedata

Eerst ingediend

30 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 mei 2026

Eerst geplaatst (Werkelijk)

14 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

6 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 2024060001 (Andere identificatie: Dao County People's Hospital Ethics Committee)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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