UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Continued ingestion test of the plant extract containing food.
Title of the study (Brief title)	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	Yasushi Shioya
Organization	Kao Corporation
Division name	Health Care Food Research Labs.
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	Aiko Shudo
Organization	Kao Corporation
Division name	Health Care Food Research Labs.
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 10 Month 13 Day
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

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Publication of results	Unpublished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