Osteopenic state Osteopenic state,Bone marker
Conditions
Interventions
Bifidobacterium bifidum 15 billion CFU per day or placebo orally for 12 weeks to study bone markers
Sponsors
Asaoka Daisuke
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Women who are at least 50 years old and less than 90 years old and have been postmenopausal for at least 1 year at the time of consent 2) Women whose bone mineral density is 71-79% of Young Adult Mean (YAM). (3) Persons who can provide written informed consent for participation in this study.
Exclusion criteria
Exclusion criteria: 1) Current or history of a serious disease such as brittle fracture, metabolic bone disease, chronic disease that may affect bone (e.g., severe renal or hepatic disease, thyroid or parathyroid disease, autoimmune disease, vitamin D deficiency or insufficiency), muscular disease such as sarcopenia, bowel disease, cancer, malabsorption or eating disorders or history of serious diseases such as sarcopenia, intestinal diseases, cancer, malabsorption or eating disorders. 2) Persons who are unable to discontinue foods or supplements containing lactobacilli, bifidobacteria, oligosaccharides, etc. during the study period. 3) Persons with milk allergy or with a history of milk allergy 4) Those who are regularly using medicines that affect the intestinal microflora (antibiotics, laxatives, intestinal regulators, etc.) 5) Patients who are regularly using drugs that affect bone metabolism (menopausal hormone therapy, bisphosphonates, raloxifene, calcitonin, growth hormone, parathyroid hormone, steroids, vitamin D preparations, etc.) within 3 months of the start of the study 6) Subjects who have participated in trials of other drugs or foods within the past month, or who intend to participate in such trials. 7) Subjects who are judged to be unsuitable as subjects by the investigator based on the results of the subject background and other factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood bone resorption marker CTX: change from baseline to 12 weeks of intake | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood bone formation marker total P1NP: change from baseline to 12 weeks TRACP-5b, a marker of bone resorption in blood: change from baseline to 12 weeks Urinary bone resorption marker NTX: change from baseline to 12 weeks Urinary bone resorption marker DPD: change from baseline to 12 weeks | — |
Contacts
Public ContactDaisuke Asaoka
Gastroenterology
Outcome results
None listed