UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A double-blind, randomized, placebo-controlled clinical trial to investigate the effect of the foods containing plant extract (Ex.no.H27-1211)
Title of the study (Brief title)	A clinical trial to investigate the effect of the foods containing plant extract
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effect on prevalence of cold and upper airway inflammation of 8 week-ingestion of the foods containing plant extract
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Prevalence of cold and upper airway inflammation
Key secondary outcomes	Degree of cold and upper airway inflammation

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Food containing plant extract for 8 weeks
Interventions/Control_2	Food without plant extract for 8 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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	69 years-old >=
Gender	Male and Female
Key inclusion criteria	Subjects giving written informed consent.
Key exclusion criteria	1) Subjects consuming foods enriched with polyphenols 2) Subjects with cold before the study 3) Subjects with a history of allergy or might be liable to allergy related to the study 4) Subjects who have serious historical disease, marked impairment, or treatment in the liver, kidney, heart, lung, gastrointestinal tract, blood, endocrine system, or metabolism system 5) Subjects who are ineligible due to physician's judgment 6) Subjects who participate in other clinical trials 7) Subjects who plan to become pregnant, who are during pregnancy, or who are nursing 8) Subjects who are ineligible due to life-style questionnaire
Target sample size	90

Research contact person
Name of lead principal investigator	Masayuki Sugimoto
Organization	Koganeibashi Sakura Clinic
Division name	Doctor
Address	2-11-25, Sakuramachi, Koganei city, Tokyo, Japan
TEL	042-382-5252
Email	Info.food@kb-clinic.com

Public contact
Name of contact person	Soichi Yoneda
Organization	QOL RD Co.,Ltd.
Division name	CRO Department Food Division.
Address	2-14-1,Nihonbashi,Chuo-Ku,Tokyo,Japan
TEL	03-6386-8809
Homepage URL
Email	s-yoneda@qol-rd.co.jp

Sponsor
Institute	QOL RD Co.,Ltd.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Kao Corporation
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	医療法人社団翔医会小金井橋さくらクリニック

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 04 Day
Anticipated trial start date	2016 Year 01 Month 30 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 01 Month 29 Day
Last modified on	2016 Year 07 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024007