Effects of a Test Food for Bone Metabolism Marker

Not Applicable

• Conditions: /A(healthy adults)

• Registration Number: JPRN-UMIN000033460
• Lead Sponsor: MORINAGA & CO., LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-03
• Study Completion: 2018-12-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)