Tokyo, Aug. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062671) titled 'Study on the effect of single intake of food containing Salacia reticulata and food containing acetic acid bacteria extract powder on promoting alcohol metabolism after drinking in adults' on Aug. 24.

Study Type: Interventional

Study Design: Basic Design - Cross-over 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 exploratorily evaluate the effect of single intake of food containing Salacia reticulata or food containing acetic acid bacteria extract powder before alcohol consumption on promoting alcohol metabolism after drinking in adults aged 20 years and older. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Single intake of test food A 3 tablets with 150 mL of water (intake of 180 mL of Japanese sake for 10 minutes at 10 minutes after intake) Interventions/Control_2 - Single intake of test food B 3 tablets with 150 mL of water (intake of 180 mL of Japanese sake for 10 minutes at 10 minutes after intake)

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 study, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate.

2. Persons who have daily drinking experience and can drink 180 mL of Japanese sake (15% alcohol) without problem, but are aware of feeling drunk.

3. Japanese persons aged 20 years or older and under 65 years at the time of obtaining consent. Key exclusion criteria - 1. Persons who have chronic diseases and are receiving medical treatment, or who have a history of serious diseases.

2. Persons who have been diagnosed with diabetes.

3. Persons who regularly take medicines or health foods with health claims (specified health foods, foods with function claims, and foods with nutrient function claims) that may affect 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 (equivalent to 60 g or more of alcohol per day: beer about 1500 mL, wine about 540 mL, Japanese sake about 330 mL, or double whisky about 180 mL).

6. Persons who usually consume a large amount of the test foods.

7. Persons who are judged inappropriate as study participants based on their responses to the background survey.

8. Persons who have participated in other clinical studies within 1 month prior to obtaining consent for this study, or who plan to participate in other clinical studies after consenting to this study.

9. Persons who are breastfeeding, pregnant, or planning or hoping to become pregnant during the study period.

10. Persons who are judged inappropriate as study participants by the principal investigator. Target Size - 45

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 21 Day Anticipated trial start date - 2026 Year 08 Month 24 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071749

Disclaimer: Curated by HT Syndication.