Healthy volunteers
Conditions
Interventions
Intake of test food for 24 weeks
Intake of placebo for 24 weeks
Sponsors
Soiken Inc.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Females aged 45 years or more and less than 75 years who experienced natural menopause over a year ago 2)Subjects whose levels of low bone mineral density measurement in the femoral neck or total hip are more than Young Adult Mean (YAM) -2.5 SD and less than YAM -1.0 SD 3)Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
Exclusion criteria
Exclusion criteria: 1)Subjects receiving medical treatments for osteoporosis 2)Subjects with serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 3)Subjects who take regularly pharmaceuticals and quasi-drugs which have the efficacy for bone mineral density or bone metabolism 4)Subjects who take regularly Foods for Specified Health Uses, Foods with Function Claims and supplements which have the possibility of the effects on bone mineral density or bone metabolism 5)Subjects who have the possibility of developing allergic symptoms by the test food 6)Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood) 7)Subjects who took part in another study within 3 months prior to the start of the present study or who is currently taking part in another study 8)Subjects deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood analysis (TRACP-5b) | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood analysis (NTx, BAP, osteocalcin, IGF-1), urinalysis (deoxypyridinoline/creatinine), bone mineral density (femoral neck and total hip) | — |
Countries
Japan
Contacts
Public ContactMai Hamada
Soiken Inc. R&D Division
Outcome results
None listed