Healthy adult female
Conditions
Interventions
Sponsors
Medical Corporation Hokubukai Utsukushigaoka Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Japanese female aged 50 to 69 years old who have passed more than one year after natural menopause (2) BMI 18.5 or more and less than 30.0 (3) Subjects who are concerned about their bone health; for example, subjects whose family members have a history of fractures (femur, tibia, spine) other than fingers (4) Subjects who consented to participate in this trial in writing with his/her own will after receiving sufficient explanations
Exclusion criteria
Exclusion criteria: (1) Subjects diagnosed with osteoporosis (2) Subjects who suffer from the following chronic diseases and under medication: rheumatism, cerebrovascular disease, arrhythmia under treatment with warfarin, thyroid disease, adrenal gland disease (3) Subjects with diabetes, hyperlipidemia or hypertension who are poorly controlled by medication (4) Subjects with hepatic disorder (5) Subjects with renal disorder (6) Subjects with serious anemia (7) Subjects who may cause allergic symptoms to the test food ingredients (polyphenols, gelatin, etc.) (8) Subjects who may cause serious allergic symptoms due to ingestion of food or medicines (9) Subjects who suffer from alcoholism or other mental disorder or have such a history (10) Subjects who take supplements, foods for specified health uses, foods with functional claims, or foods with nutrient function claims that affect bone metabolism once or more per week, such as calcium, vitamin D, vitamin K, magnesium, isoflavones (including daidzein, genistein, equol, etc.) (11) Subjects who plan to take foods with health claims or supplement foods newly during the study period (12) Subjects who have received hormone replacement therapy within the past 6 months (13) Subjects who have suffered a bone injury or illness such as a fracture within the past 6 months (14) Subjects who have received treatment requiring hospitalization within the past 6 months (15) Subjects who participated in other human clinical trials within the past 3 months, or those who plan to participate in other human clinical trials during the study period (16) Subjects judged as unsuitable for the study by the investigator with other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone metabolism markers (BAP:bone alkaline phosphatase, P1NP, TRACP-5b, NTX) | — |
Secondary
| Measure | Time frame |
|---|---|
| Antioxidant markers (BAP:biological antioxidant potential, dROM, urinary 8-OHdG), bone markers (homocysteine, urinary pentosidine), 25OHVD, JOQOL, bone mineral content, and safety | — |
Countries
Japan
Contacts
Public ContactTakuya Matsuda
Medical Corporation Hokubukai Utsukushigaoka Hospital Clinical Pharmacology Center
Outcome results
None listed