A verification study of improvements in bone density: a randomized double-blind placebo-controlled study

Recruitment & Eligibility

Status: Complete: follow-up complete

Sex: Female

Target Recruitment: 38

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, dyslipidemia, hypertension, or any other chronic diseases 3. Subjects who take supplements, "Foods for Specified Health Uses," "Foods with Functional Claims," or "Foods with Nutrient Function Claims" related to bone metabolism, such as calcium, vitamin D, vitamin K, magnesium, isoflavones, (included daidzein, genistein, equol, or etc.), more than once a week 4. Currently taking medications (include herbal medicines), "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage 5. Subjects who are allergic to medicines and/or the test food related products 6. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 7. Subjects who are judged as ineligible to participate in the study by the physician

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone density of total amount of lumbar vertebra * Measured by Dual Energy X-ray Absorptiometry (DEXA) * Perform the test at screening and examination before consuming and at 12 and 24 weeks after ingestion

Secondary Outcome Measures

Name	Time	Method
1. Left femur (thigh bone) (neck, trochanter, inter, total amount, and Ward' s): Bone area, bone mineral density, bone density, T-score, YAM score, and Z score 2. Lumbar vertebra (L2, L3, L4, and total amount): Bone area, bone mineral density, T-score, YAM score, and Z score 3. Peripheral blood test Tartrate-resistant Acid Phosphatase 5b (TRACP-5b), osteocalcin (OC), bone specific alkaline phosphatase (BAP), crosslinked N-telopeptide of type I collagen (NTx) 4. Urinalysis Crosslinked N-telopeptide of type I collagen (NTx), deoxypyridinoline (DPD) 5. Subjective symptoms Questionnaire of physical and life related to osteoporosis 1,2 Measured by Dual Energy X-ray Absorptiometry (DEXA) 1-5 Perform the tests at screening and examination before consuming and at 12 and 24 weeks after ingestion

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