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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024402
Receipt No. R000028058
Scientific Title Continued ingestion test of the plant extract containing food.
Date of disclosure of the study information 2016/10/13
Last modified on 2016/10/24

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Basic information
Public title Continued ingestion test of the plant extract containing food.
Acronym Continued ingestion test of the plant extract containing food.
Scientific Title Continued ingestion test of the plant extract containing food.
Scientific Title:Acronym Continued ingestion test of the plant extract containing food.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the complaints of ingesting the plant extract containing food of healthy female.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of Complaints.
(Evaluation time:0,2 and 4weeks after ingestion of the test food.)
Key secondary outcomes Evaluation of Health Related Quality of Life.
(Evaluation time:0,2 and 4weeks after ingestion of the test food.)

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 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Ingestion of active once a day for 28days.
Interventions/Control_2 Ingestion of control1 once a day for 28days.
Interventions/Control_3 Ingestion of control2 once a day for 28days.
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
50 years-old <=
Age-upper limit
70 years-old >
Gender Female
Key inclusion criteria 1)Informed consent provided
2)Aged between50 and 69 women
3)Persons who have had stiffness in a month.
Key exclusion criteria 1)Persons who have possibilities for emerging allergy to foods.
2)Persons who have had rheumatism or disc herniation or collagen diseases or Parkinson's disease.
3)Persons who are considered inappropriate by the investigator or project leader.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasushi Shioya
Organization Kao Corporation
Division name Health Care Food Research Labs.
Zip code
Address 2-1-3, bunka, sumida-ku, Tokyo, 131-8501, JAPAN
TEL 03-5630-7251
Email shioya.yasushi@kao.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Aiko Shudo
Organization Kao Corporation
Division name Health Care Food Research Labs.
Zip code
Address 2-1-3, bunka, sumida-ku, Tokyo, 131-8501, JAPAN
TEL 03-5630-7464
Homepage URL
Email shudou.aiko@kao.co.jp

Sponsor
Institute Macromill,Inc.
Institute
Department

Funding Source
Organization Kao Corporation
Organization
Division
Category of Funding Organization Other
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 被験者自宅

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 13 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 No longer recruiting
Date of protocol fixation
2016 Year 10 Month 13 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 13 Day
Last modified on
2016 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028058

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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