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A confirmation test of enhancing effect of the clam extract powder in alcohol metabolism

A confirmation test of enhancing effect of the clam extract powder in alcohol metabolism - A confirmation test of enhancing effect of the clam extract powder in alcohol metabolism

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000031537
Enrollment
12
Registered
2018-03-01
Start date
2018-03-02
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy subjects

Interventions

Conducting alcohol loading test after intake 2 capsules of the test-food1. More than 5 days pause period. Conducting alcohol loading test after intake 2 capsules of the test-food2. More than 5 days pa

Sponsors

CPCC Company Limited
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Males over aged 20 when informed consent. 2) Subjects who can drink alcohol. (Include subjects who are weak against alcohol from subjective symptom and subjects who don't have liver dysfunction by doctor's judge.) 3) Subjects who have received enough description of the clinical test, understanding about the clinical test and giving written informed consent.

Exclusion criteria

Exclusion criteria: 1) Subjects who can't drink alcohol. 2) Subjects who showed strong positive reaction in patch test of alcohol. 3) Subjects who constantly use medicines suspected to have influence to the results of the clinical test. (Turmeric, shellfish, levers and other hangover supplements etc.) 4) Subjects who have previous and/or current medical history of serious disease in heart, liver, kidney, digestive organ. 5) Subjects who excessive alcohol intake. 6) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work. 7) Subjects who have previous medical history of drug and/or food allergy. 8) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. 9) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. 10) Subjects who donated over 400mL blood and/or blood components within the last three month to the current study. 11) Subjects who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. 14) Others those have been determined ineligible by principal investigator or sub-investigator.

Design outcomes

Primary

MeasureTime frame
Concentration of acetaldehyde in blood at each measurement point, AUC of blood acetaldehyde, Concentration of alcohol in blood at each measurement point, AUC of blood alcohol

Secondary

MeasureTime frame
Efficacy evaluations : VAS questionnaire, alcohol in expired gas Safety evaluation : Incidence of side effect and adverse events

Countries

Japan

Contacts

Public ContactMakoto Ichinohe

CPCC Company Limited Planning & Sales Department

cpcc-contact@cpcc.co.jp03-5297-3112

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026