A Crossover Exploratory Study of NatureU Cheers Friends Curcumin on Acute Alcohol Hangover Symptoms (NUZY)
6. maj 2026 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
12
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Hunan
-
Yongzhou, Hunan, Kina, 425300
- Dao County People's Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Ikke-randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Aktiv komparator: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Difference in Acute Hangover Scale Total Score Between NatureU Cheers Friends Curcumin and Comparator Product
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Difference in Individual Acute Hangover Scale Item Scores Between NatureU Cheers Friends Curcumin and Comparator Product
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Safety and Tolerability During Test-Food Sessions
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studieleder: Luke Law, Dr, OmniSolutions Laboratory Holdings Limited
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
20. juni 2024
Primær færdiggørelse (Faktiske)
21. juni 2024
Studieafslutning (Faktiske)
21. juni 2024
Datoer for studieregistrering
Først indsendt
30. april 2026
Først indsendt, der opfyldte QC-kriterier
6. maj 2026
Først opslået (Faktiske)
14. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 2024060001 (Anden identifikator: Dao County People's Hospital Ethics Committee)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Individual participant data will not be shared due to privacy protection and ethical considerations.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .