Healthy adults (susceptible to alcohol)
Conditions
Interventions
[1]Oral intake of the test product (containing mushroom mycelium powder
2 capsules / day, 1 time) [2]Alcohol intake [3]Observation [4]Washout (1 week) [5]Oral intake of the placebo product (not containing mushroom mycelium powder
2 capsules / day, 1 time) [6]Alcohol intake [7]Observation
[1]Oral intake of the test product (not containing mushroom mycelium powder
2 capsules / day, 1 time) [2]Alcohol intake [3]Observation [4]Washout (1 week) [5]Oral intake of the placebo product (containing mushroom mycelium powder
2 capsules / day, 1 time) [6]Alcohol intake [7]Observation
Sponsors
RCT Japan Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Japanese males and females aged 20-59 years [2]Individuals who are healthy [3]Individuals who can intake alcohol and cause flushing response or have a hangover by small amount ingestion (result of ethanol patch test is ND or NN) [4]Individuals who do not have a habit of intaking alcohol [5]Individuals whose written informed consent has been obtained [6]Individuals who can come to the de signated venue for this study and be inspected [7]Individuals judged appropriate for the study by the principal
Exclusion criteria
Exclusion criteria: [1]Individuals whose result of ethanol patch test is DD [2]Individuals using medical products [3]Individuals who is patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia [4]Individuals who take medicine in the past 1 month to remedy disease (except of temporal taking medicine for headache, menstrual pain, or cold) [5]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease [6]Individuals who is a patient or have a history of or endocrine disease [7]Individuals whose BMI is over 30kg/m2 [8]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months [9]Individuals with serious anemia [10]Individuals who are sensitive to test product or other foods, and medical products [11]Individuals who are or are possibly, or are lactating [12]Individuals whose life style will change during the test period (ex. a night shift, travel for a long time, job transfer) [13]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements to improve liver function in the past 3 month or will ingest those foods during the test period [14]Individuals who participated in other clinical studies in the past 3 months [15]Individuals judged inappropriate for the study by the principal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *Alcohol Metabolic Capacity [1]Blood alcohol content (First observation, Second observation) [2]Acetaldehyde (First observation, Second observation) [3]Urine creatinine (First observation, Second observation) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Antioxidant [1]Diacron-Reactive Oxygen Metabolites test (First observation, Second observation) [2]Biological Antioxidant Potential test (First observation, Second observation) [3]Urinary 8-OHdG (First observation, Second observation) *Discomfort [1]Profile of Mood States (Japanese version) (First observation, Second observation) [2]Visual Analogue Scale (First observation, Second observation) *Safety [1]Blood pressure, pulsation (Preliminary observation, First observation, Second observation) [2]Weight, body fat percentage, BMI (Preliminary observation, First observation, Second observation) [3]Body temperature (Preliminary observation, First observation, Second observation) [4]Doctor's questions (Preliminary observation, First observation, Second observation) *Other indexes [1]Hematologic test (Preliminary observation, First observation, Second observation) [2]Blood biochemical test (Preliminary observation, First observation, Second observation) [3]Urine analysis (Preliminary observation, First observation, Second observation) [4]Subject's diary (each day during the test period) [5]Ethanol patch test (Preliminary observation) | — |
Countries
Japan
Contacts
Public ContactToshiyasu Tamura
TES Holdings Co., Ltd. Department of Clinical Trial
Outcome results
None listed