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Effects of a Test Food for Bone Metabolism Marker

Effects of a Test Food for Bone Metabolism Marker - Effects of a Test Food for Bone Metabolism Marker

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000033460
Enrollment
24
Registered
2018-08-03
Start date
2018-08-03
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

N/A(healthy adults)

Interventions

Sponsors

MORINAGA & CO., LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Japanese males and females aged 40-79 years. 2)Individuals who are healthy (women over 1 year after menopause) and who do not fall under the following items. Individuals who is taking medication for diseases related to bone In the past month, individuals who have drug ingestion and application habits aimed at disease treatment (excluding draft of medicine for condition such as headache, common cold) Individuals who have anamnesis and present history of the disease about the disability of internal organs, blood etc. Individuals who are judged to be presently in a disease state by judgment of examination doctor judgment and blood sampling, or self-declaration. Individuals who had self-assessment of past medical history within the past 6 months. Individuals who have advanced anemia. 3)Individuals who care about bone health. 4)Individuals whose written informed consent has been obtained. 5)Individuals who can visit an inspection facility and be inspected in designated days. 6)Individuals juged approprate for the study by the principal.

Exclusion criteria

Exclusion criteria: 1)Individuals using medical products and are judged that treatment is necessaryby examination doctor. 2)Individuals who have advanced anemia. 3)Individuals who have possibility of allergy symptoms onset by the test food and who cause severe allergic symptoms in foods and medicines, persons with fear of oral allergy syndrome and latex fruit syndrome. (In particular, gelatin, peach, pork, banana, melon, avocado, pineapple, papaya, mango, peach, kiwi, chestnut, tomato, cashew nut, pistachio) 4)Individuals who have an addiction to alcohol or a mental illness. 5)Individuals who have a habit of smoking. 6)Individuals whose life style will change during the test period. 7)Individuals with probable seasonal allergy, such as pollinosis, during the test period.(In particular, Betulaceae: alder, oba alnus firma, shirakaba, Taxodiaceae: cryptomeria, hinoki cypress, Asteraceae: ragweed, Artemisia vulgaris indica, Gramineae:Dactylis glomerata, Phleum pratense) 8)Individuals who will ingest health-promoting foods, foods for specified health uses, health foods, or supplements during the test period. 9)Individuals who conducted hormone replacement therapy in the past 6 months. 10)Individuals who have suffered bone injuries or illnesses such as fractures in the past 6 months. 11)Individuals who were hospitalized and received treatment in the past 6 months. 12)Individuals who participated in other clinical studies in the past 3 months. 13)Individuals judged inappropriate for the study by the principal.

Design outcomes

Primary

MeasureTime frame
Fasting blood index for bone metabolism marker (BAP,P1NP,NTX,TRACP-5b,ucOC),urinary index for bone metabolism marker (CTX,DPD) : 0 and 12 weeks after a test food intake.

Secondary

MeasureTime frame
Doctor's qustions (0 and 12 weeks after a test food intake), Questionnaire, Subject's diary (From the first day of ingetion of atest food to the last day of the test)

Countries

Japan

Contacts

Public ContactTakayuki Yamamoto

Morinaga & Co.,Ltd Health Science and Research Center, R&D institute

t-yamamoto-jc@morinaga.co.jp045-571-2982

Outcome results

None listed

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