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A confirmation study of improvements in bone metabolism: a randomized, double-blind, placebo-controlled, crossover trial

A confirmation study of improvements in bone metabolism: a randomized, double-blind, placebo-controlled, crossover trial - A confirmation study of improvements in bone metabolism

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000038627
Enrollment
48
Registered
2019-11-19
Start date
2019-11-19
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Japanese adult people

Interventions

I. active food 1 II. active food 2 III. placebo food Duration: 4 weeks Dose: 1 pack, once a day (4 g) Administration: Take pack after meal with water, warm water, coffee, apple juice, or e

Sponsors

Chubu University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Japanese adult female

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactDaiki Suehiro

San-ei Sucrochemical Co., Ltd. Research and Development Section

daiki-suehiro@sanei-toka.co.jp0562-55-5197

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026