A confirmation study of improvements in bone metabolism: a randomized, double-blind, placebo-controlled, crossover trial
Not Applicable
- Conditions
- Healthy Japanese adult people
- Registration Number
- JPRN-UMIN000038627
- Lead Sponsor
- Chubu University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 44
Inclusion Criteria
Not provided
Exclusion Criteria
1. A medical history of malignant tumor, heart failure or myocardial infarction. 2. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus. 3. Subjects who are allergic to the test food related products.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Urinalysis Crosslinked N-telopeptide of type I collagen (NTx), deoxypyridinoline (DPD). *Examinations will be performed before and 4 weeks after intake of the test food.
- Secondary Outcome Measures
Name Time Method 1.Peripheral blood test Tartrate-resistant Acid Phosphatase 5b (TRACP-5b), osteocalcin (OC), bone specific alkaline phosphatase (BAP),calcitonin(CT) *Examinations will be performed before and 4 weeks after intake of the test food. 2.calcaneus bone: SOS score, T-score, YAM score, and Z score * Measured by quantitative ultrasound (QUS). * Perform the test at screening. 3.Dietary assessment method brief-type self-administered diet history questionnaire (BDHQ) *examination before consuming and at 4 weeks after ingestion