Tokyo, Feb. 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060774) titled 'A study to verify the effects of nomimamori gummy on promoting alcohol metabolism and removing acetaldehyde: an open-label study' on Feb. 27.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - National university corporation Tokushima University

Condition: Condition - Healthy Japanese Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To verify the effects of nomimamori gummy on promoting alcohol metabolism and removing acetaldehyde. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: Single ingestion Interval period: two weeks Test product: nomimamori gummy Administration: Test 1: Each measurement is performed after drinking 100 mL per 60 kg body weight of 25% shochu (ethanol content: 25 mL per 60 kg body weight) over five minutes. Test 2: Take three test products of the test food (chewing each test product 30 times), then drink 100 mL per 60 kg body weight of 25% shochu over five minutes, after which each measurement is performed.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - 1. Japanese

2. Men or women

3. Individuals aged between 20 and 50

4. Healthy individuals

5. Individuals who show moderate activity in alcohol-metabolizing gene test (Genemetry) Key exclusion criteria - 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction

2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, stroke disorder, dyslipidemia, hypertension, neoplastic disease, hemorrhagic disease, infectious disease, or any other chronic diseases

4. Individuals who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional foods/beverages on a daily basis

5. Individuals who are currently taking medications (including herbal medicines) and supplements

6. Individuals who are allergic to medicines and foods related to the test food (particularly alcohol)

7. Individuals who are pregnant, lactating, or planning to become pregnant during this study

8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study

9. Individuals who are smokers

10. Individuals who plan to drive a car or ride a bicycle after the examinations on the test day

11. Individuals who are judged as ineligible to participate in this study by the physician Target Size - 15

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 02 Month 18 Day Date of IRB - 2026 Year 02 Month 18 Day Anticipated trial start date - 2026 Year 02 Month 27 Day Last follow-up date - 2026 Year 03 Month 18 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069502

Disclaimer: Curated by HT Syndication.