None listed
Conditions
Interventions
Food containing low-dose plant extract, single ingestion
Food containing high-dose plant extract, single ingestion
Food not containing plant extract, single ingestion
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Males aged 30 to 59 years-old. (2) Subjects who are healthy and are not suffered from chronic disease. (3) Subjects who can take alcohol (ND type or NN type in the alcohol patch test), and are likely to have a hangover the next day. (4) Subjects who can make self-judgment and are voluntarily giving written informed consent. (5) Subjects who can have an examination on a designated check day. (6) Subjects who are judged as suitable for the current study by the investigator.
Exclusion criteria
Exclusion criteria: (1) Subjects with DD type in the alcohol patch test. (2) Subjects who have never had a hangover. (3) Subjects who have excessive alcohol intake more than 60 g/day of pure alcohol equivalent. (4) Subjects who contract disease and are under treatment. (5) Subjects who have a history of and/or contract serious diseases (eg, hyperlipidemia, high blood pressure, diabetes, psychiatric disease, sleeping disorder ). (6) Subjects who used a drug to treat a disease in the past 1 month (except temporal usage for headache and cold). (7) Subjects who have a history of and/or contract serious diseases (eg, liver disease, kidney disease, heart disease, lung disease, blood disease). (8) Subjects who have a history and/or contract digestive disease (except disease of an appendix). (9) Subjects whose BMI are under 18.5 or 30 or more. (10) Subjects with serious anemia. (11) Subjects who have allergic reaction to ingredients of test foods and other foods or drugs. (12) Subjects with possible changes of life style, such as a long-term travel and a late-night shift, during test periods. (13) Subjects who have a habit to use Foods with Function Claims, functional foods and/or supplements claiming to improve liver function (curcumin, clam extract, liver extract, etc.) in the past 3 months and/or are planning to use those foods during test periods. (14) Subjects who have difficulty in taking meals (dinner and lunch on the inspection day). (15) Subjects who are participating and/or had participated in other clinical studies within the last three months prior to the current study. (16) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Questionnaires on a hangover | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed