UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033460 |
|---|---|
| Receipt number | R000038149 |
| Scientific Title | Effects of a Test Food for Bone Metabolism Marker |
| Date of disclosure of the study information | 2018/08/03 |
| Last modified on | 2020/08/03 17:04:55 |
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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
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
t-yamamoto-jc@morinaga.co.jp
Sponsor or person
Institute
MORINAGA & CO., LTD.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038149
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