Healthy subjects
Conditions
Interventions
Intake placebo beverage on the day Washout Intake test beverage on the day
Intake test beverage on the day Washout Intake placebo beverage on the day
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Healthy Japanese males who are between 20 and 35 years of age at the time of written informed consent. 2.BMI less than 25.0 kg/m2. 3.No smoker (No smoking past one year). 4.Subjects who are fully explained the purpose and details of the study, have ability to consent, are volunteering to participate in the study with a full understanding of the explanation, and have consented to participate in the study in writing.
Exclusion criteria
Exclusion criteria: 1.Receiving continuous pharmaceutical treatment with drugs including commercial pharmaceuticals and Chinese medicines due to some kind of illness excluding use as needed. 2.Receiving any dietary or exercise treatment under medical doctors. 3.Current or a history of mental disease, sleep disorder, hypertension, diabetes, dyslipidemia, or serious illness. 4.Current or a history of serious disorders of the liver, kidneys, heart, lungs, blood. 5.A gastrointestinal comorbidity or serious medical history. 6.Using implanted medical devices containing pacemakers or blood vessel clips. 7.A habit of taking drugs for treating diseases in past one month, excluding dismissal history of drugs for headaches, colds. 8.Have been taking any products (e.g., foods for specified health use, foods with functional health claims , health foods, drugs, quasi-drugs) that affect autonomic nervous system, metabolism and sleep, excluding who can quit intake during the study. 9.A constitutional difficulty in drinking alcohol. 10.At risk of developing hay fever or seasonal allergy symptoms or have allergic rhinitis during the study period. 11.Have or at risk of developing drug or food allergy symptoms. 12.Have difficulty wearing a heart rate monitor, such as an allergy to tape (such as bandage). 13.Alcohol drinkers, over 60 g/day of alcohol on daily basis. 14.Extremely irregular eating habits. 15.Night workers or Shift workers. 16.Under significant stress of any life event within 3 months before IC, or will have such a life event during the study period. 17.Have participated another clinical study within 1 month before IC, or will participate in it during the study period or within 1 month after the end of the study. 18.Cannot quit drinking from the day before the test date. 19.Have claustrophobia. 20.Current or a history of mental disorder containing depression.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| fMRI | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) Questionnaire concerning psychological evaluation pulse rate (Safety evaluation) adverse events | — |
Countries
Japan
Contacts
Public ContactHidemasa Toya
HUMA R&D CORP Clinical Development Department
Outcome results
None listed