UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033460
Receipt No. R000038149
Official scientific title of the study Effects of a Test Food for Bone Metabolism Marker
Date of disclosure of the study information 2018/08/03
Last modified on 2018/07/20

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Effects of a Test Food for Bone Metabolism Marker
Title of the study (Brief title) 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,CTX,TRACP-5b,ucOC),urinary index for bone metabolism marker (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 Sadao Mori
Organization Morinaga & Co.,Ltd
Division name Health Science and Research Center, R&D institute
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 Takayuki Yamamoto
Organization Morinaga & Co.,Ltd
Division name Health Science and Research Center, R&D institute
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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 06 Month 26 Day
Anticipated trial start date
2018 Year 08 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

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


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.