Healthy adult
Conditions
Interventions
Daily ingestion of lactulose and milk calcium for 48 weeks.
Daily ingestion of glucose and milk calcium for 48 weeks.
Sponsors
Hokkaido Information University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Subjects who fully understand significance, content and purpose of this study and who agree to participate in this study with a written informed consent. 2 . Japanese women who have been postmenopausal for more than 1 year. 3. Subjects whose T-score is >-2.5 and <-1.0.
Exclusion criteria
Exclusion criteria: 1. Subjects with serious cancer, respiratory, hepatic, renal, cardiac, lung, gastrointestinal, blood, endocrine, metabolism diseases, and/or have serious medical history those disease. 2. Subjects with gastrointestinal disorders such as irritable bowel syndrome or inflammatory bowel disease. 3. Subjects with major surgical history relevant to the digestive system. 4. Subjects who regularly take medicine which would affect intestinal environment and/or bone metabolism. 5. Subjects who cannot abstain from taking functional foods (food for specified health uses, foods with function claims, foods with nutrient function claims) which affect intestinal environment, bone metabolism, and/or bone density, supplements which contain vitamin D3 and/or mineral. 6. Subjects who are at risk of having allergic reactions to drugs or foods, especially milk. 7. Subjects with lactose intolerance. 8. Subjects with a history of lumbar spine or hip surgery, and/or who have metal plates on their lumbar spine and/or hip. 9. Subjects who use pacemakers and/or defibrillators. 10. Subjects who currently participate in other clinical trials or participated within the last 4 weeks prior to the current study. 11. Subjects whose BMI is >=30 kg/m2. 12. Subjects who are ineligible due to physician's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone mineral density (lumbar spine, left femur) | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood bone metabolism markers : Bone-type alkaline phosphatase (BAP), Tartate-resistant acid phosphatase-5b (TRACP-5b), Total procollagen type 1 -N-propeptide (t-P1NP), undercarboxylated osteocalcin (ucOC) Urinary bone metabolism markers: Deoxypyridinoline (DPD), Type I collagen cross-linked N-telopeptides (NTX) Organic acids in blood faecal microbiota | — |
Countries
Japan
Contacts
Public ContactNaoyuki HONMA
Hokkaido Information University Health Information Science Center
Outcome results
None listed