UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for evaluating the immunostimulating effect -A Randomized, double-blind, placebo controlled trial.
Title of the study (Brief title)	A study for evaluating the immunostimulating effect
Region	Japan

Condition
Condition	Healthy adults who feel fatigue
Classification by specialty	Medicine in general Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of test food on immune functions.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Scoring of Immunological Vigor after 4 weeks of intervention
Key secondary outcomes	Immunological parameters Physical examinations Urinary test Blood test Questionnaires (Likert) :after 4 weeks of intervention

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	Test food Duration: 4 weeks Dose: daily recommended dose Usage: intake at optional timing
Interventions/Control_2	Placebo food Duration: 4 weeks Dose : daily recommended dose Usage: intake at optional timing
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	a) Healthy adults, who feel fatigue b) Persons whose ages are 20 years or older c) Low immunity score (scoring immunological vigor: between 13 and 23) on visit 1's examination
Key exclusion criteria	a) Persons who have previous medical history of cancer, heart failure and cardiacinfarction b) Patients being treated for arterial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes, digestive system disorder, autoimmune disorder, dyslipidemia, hypertension, and other chronic disease c) Persons who takes medicines, herbal medicines, and dietary supplements d) Persons who take in foods with an influence on Primary outcomes to more than three times a week in large quantities e) Persons who take in foods with an influence on intestinal regulation to more than three times a week in large quantities f) Persons who has allergy g) Pregnant women, lactating women, or women who want to get pregnant during the trial period h) Persons who enrolled in the other clinical trials within last 3 months before the agreement for the participation to the trial i) Persons who investigator judge not suitable to participate in the trial
Target sample size	40

Research contact person
Name of lead principal investigator	Kazuo YAMAMOTO
Organization	ORTHOMEDICO, Inc.
Division name	R&D Department
Address	3F Sofia Ochanomizu, 2-4-3 Yushima, Bunkyo-ku, Tokyo
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	Naoko SUZUKI
Organization	ORTHOMEDICO, Inc.
Division name	R&D Department
Address	3F Sofia Ochanomizu, 2-4-3 Yushima, Bunkyo-ku, Tokyo
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO, Inc.
Institute
Department

Funding Source
Organization	Lotte Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Seishin-kai medical Association Inc, Takara clinic.
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　盛心会　タカラクリニック（東京都） Seishin-kai Medical Association Inc, Takara clinic(Tokyo)

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 19 Day
Anticipated trial start date	2016 Year 04 Month 20 Day
Last follow-up date	2016 Year 08 Month 09 Day
Date of closure to data entry	2016 Year 08 Month 09 Day
Date trial data considered complete	2016 Year 09 Month 21 Day
Date analysis concluded	2016 Year 10 Month 12 Day

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

Management information
Registered date	2016 Year 04 Month 19 Day
Last modified on	2017 Year 03 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025321