Healthy subjects
Conditions
Interventions
16-weeks intake of the test food
16-weeks intake of the placebo food
Sponsors
Pharma Foods International Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Japanese healthy male and female subjects whose ages are 30 <= years old <65 at the time of obtaining written consent. 2.Subject who is not currently receiving treatment or medication. 3.Subject whose liver function marker values correspond to one of the following two. a.Liver function marker (ALT) is normal, ALT is 20 or more and 30 or less. b.Liver function marker (ALT) is slightly higher, ALT is 31 or more and 50 or less. 4.Subject who has received sufficient explanation of the purpose and content of the research, have the ability to consent, voluntarily volunteered to participate in the examination after understanding it well, and agreed to participate in the examination in writing. 5.Subject who is not expected to meet the exclusion criteria from the results of the primary SCR background questionnaire.
Exclusion criteria
Exclusion criteria: 1.Subject who has been diagnosed with serious liver disease (viral hepatitis, drug-induced liver injury, liver cirrhosis, etc.) by a doctor, or those who have a medical history or are suspected (hepatitis virus test positive, etc.) 2.Subject who is currently undergoing medication or outpatient treatment due to some serious illness. 3.Subject who is under exercise therapy or dietetic therapy. 4.Subject who may develop allergies due to test foods. 5.Subject with current or history of drug or alcohol dependence. 6.Alcohol polydipsia. 7.Subject who is out of the hospital due to mental disorders (depression, etc.) or sleep disorders(Insomnia, sleep apnea syndrome, etc.), or who has a history of mental illness in the past. 8.Subject with irregular life rhythms due to night shifts or shift work. 9.Subject who has extremely irregular lifestyle habits such as eating and sleeping. 10.Subject who has an extremely unbalanced diet. 11.Subject with serious current or history of brain disease, malignant tumor, immune disease, diabetes, renal disease, heart disease, thyroid disease, adrenal disease, and other metabolic diseases. 12.Subject who uses or cannot refrain from using health foods, supplements, medicines, quasi-drugs, Chinese medicine, etc. that contain ingredients that affect liver function (eg, ornithine, sulforaphane, turmeric, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver function markers(ALT,AST,Gamma-GTP) | — |
Secondary
| Measure | Time frame |
|---|---|
| (Safety evaluation) Vital signs, physical measurement, blood biochemistry, hematology, urinalysis, adverse events | — |
Countries
Japan
Contacts
Public ContactHidemasa Toya
HUMA R&D CORP Clinical Development Department
Outcome results
None listed