UMIN-CTR Clinical Trial

Basic information
Public title	Effects of a Test Food for Bone Metabolism Marker
Acronym	Effects of a Test Food for Bone Metabolism Marker
Scientific Title	Effects of a Test Food for Bone Metabolism Marker
Scientific Title:Acronym	Effects of a Test Food for Bone Metabolism Marker
Region	Japan

Condition
Condition	N/A(healthy adults)
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to examine effects of a test food for bone metabolism marker.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	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.
Key secondary outcomes	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)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Oral ingestion of the test food (12 weeks)
Interventions/Control_2	Oral ingestion of the placebo food (12 weeks)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key 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.
Key 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.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Middle name Last name Sadao Mori
Organization	Morinaga & Co.,Ltd
Division name	Health Science and Research Center, R&D institute
Zip code
Address	2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama
TEL	045-571-2982
Email	s-mori-ab@morinaga.co.jp

Public contact
Name of contact person	1st name Middle name Last name Takayuki Yamamoto
Organization	Morinaga & Co.,Ltd
Division name	Health Science and Research Center, R&D institute
Zip code
Address	2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama
TEL	045-571-2982
Homepage URL
Email	t-yamamoto-jc@morinaga.co.jp

Sponsor
Institute	MORINAGA & CO., LTD.
Institute
Department

Funding Source
Organization	MORINAGA & CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 08 Month 03 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2018 Year 06 Month 26 Day
Date of IRB	2018 Year 06 Month 27 Day
Anticipated trial start date	2018 Year 08 Month 03 Day
Last follow-up date	2018 Year 12 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 07 Month 20 Day
Last modified on	2020 Year 08 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038149