Tokyo, Sept. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059197) titled 'Examination of the effect of test food intake on the promotion of alcohol metabolism after drinking in adults' on Sept. 26.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - BIOSIS Lab. Co., Ltd.
Condition:
Condition - Healthy Adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the effects of a food containing acetic acid bacteria extract powder on alcohol metabolism after drinking in adults aged 20 years or older.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Take three test meals before drinking alcohol
Interventions/Control_2 - Take three placebo tablets before drinking alcohol
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1. Persons who received a sufficient explanation of the purpose and contents of the research, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate
2. Persons who regularly drink alcohol and can drink 180 mL of sake (15% alcohol) without any problems, but are aware of getting drunk.
3. Persons who are Japanese citizens, aged 20 or older and under 65 at the time of consent
Key exclusion criteria - 1. Persons who have chronic diseases and are receiving drug treatment, or have a history of serious illness
2. Persons who have been diagnosed with diabetes
3. Persons who usually take medicine, specified health food, foods with function claims, and foods with nutrient function claims that may have effects on alcohol metabolism or sleep quality
4. Persons who are at risk of developing allergies related to the test foods
5. Persons who drink a large amount of alcohol (60 g or more of alcohol per day: approximately 1500 mL of beer, 540 mL of wine, 3 cups of sake, or 180 mL of double-sized whiskey)
6. Persons who regularly consume large amounts of the test food
7. Persons who are judged unsuitable as research subjects based on their responses to a background survey
8. Persons who have participated in other research during one month prior to the start of this research, or plan to participate in other research after consenting to this research.
9. Persons who are breastfeeding, pregnant, or have plans to become pregnant during the study period
10. Persons who are judged to be ineligible by the principal investigator
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 11 Day
Date of IRB - 2025 Year 09 Month 11 Day
Anticipated trial start date - 2025 Year 10 Month 02 Day
Last follow-up date - 2025 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067706
Disclaimer: Curated by HT Syndication.
