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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-UMIN000034257
Enrollment
68
Registered
2018-10-01
Start date
2018-10-02
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. Maltobionic acid containing corn syrup solid (Calcium maltobionate) II. Placebo supplement Duration: 4 weeks Dose: 1 pack, once a day (4 g) Administration: Take pack after meal with water,

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.Dietary assessment method brief-type self-administered diet history questionnaire (BDHQ) *examination before consuming and at 4 weeks after ingestion 2.The Japanese version of Constipation Assessment Scale MT version (CAS-MT) *Perform the test at 0 week and at 1 and 2 and 3 and 4 weeks after the 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