Healthy subjects
Conditions
Interventions
Ingestion of the test food once on the day of the test.
Ingestion of the placebo food once on the day of the test.
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Japanese male and female aged 20 to 60 years of aged at the time of the informed consent. 2.Subject with BMI from 20.2 kg /m2 less than 27.2 kg /m2 for males and 18.5 kg /m2 less than 25.2 kg /m2 for females. 3.Non-smoker 4. Subject who has received sufficient explanation of the purpose and content of the research, has the ability to consent.
Exclusion criteria
Exclusion criteria: 1.Subject who is taking medication or under medical treatment due to serious illness. 2.Subject who has experienced chest pain or abnormal pulse at rest. 3.Subject who has or had a history of severe diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), kidney disease, heart disease, thyroid disease, adrenal disease, other metabolic diseases. 4.Subject who is treating rheumatism. 5.Subject who frequently experiences shortness of breath, dizziness, and loss of consciousness. 6.Subject who has or had a history of drug allergies, food allergies, or allergies to raw materials for test foods (milk protein etc.). 7.Subject who has a family member who died suddenly of unknown causes. 8.Subject who has been diagnosed as having problems with the legs and hips. 9.Subject with knee surgery or disease, or those who use a cane on a daily basis. 10.Subject who has or had a history of either medicine or alcohol dependence syndrome. 11.Subject who has or had suspected of disorder with mental (such as depression) or sleep (such as insomnia and sleep apnea syndrome). 12.Subject who has extremely irregular lifestyle such as eating and sleeping. 13.Subject who has an unbalanced diet. 14.Subject who has irregular life rhythms such as working at night. 15.Subject who works in factories, construction sites, etc. and perform physical labor that overuses the body.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective evaluation of the bodily sensation using questionnaire (frequency and intensity of bodily sensation, and their cumulative value), physical condition changes after meals, vital signs,BMI,adverse events | — |
Countries
Japan
Contacts
Public ContactDaisuke Ochitani
HUMA R&D CORP Public relations department
Outcome results
None listed