UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The verification study of improvements in psychological stress: a randomized double-blind, parallel-group, placebo-controlled trial
Title of the study (Brief title)	The verification study of improvements in psychological stress
Region	Japan

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

Objectives
Narrative objectives1	To verify the improvement of psychological stress with intake of the test food
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Autonomic function * Assess at screening and examination before consuming and at 4 and 8 weeks after consuming. Perform the test before and after psychological stress load.
Key secondary outcomes	1. Salivary amylase activity 2. Salivary cortisol activity 3. Pepsinogen I (PGI) 4. Pepsinogen II (PGII) 5. PGI/PGII 6. Profile of Mood States 2nd Edition (POMS2) Japanese version 7. Izumo Scale 8. Original questionnaires 8a. Visual Analogue Scale (VAS) 8b. Likert scale *1-6,8a Assess at screening and examination before consuming and at 4 and 8 weeks after consuming. Perform these assessments before and after psychological stress load. *7,8b Assess at screening and examination before consuming and at 4 and 8 weeks after consuming. Perform the assessment before psychological stress load.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 8 weeks Test material: Active capsule Dose: Take 3 capsules per day Administration: Take a capsule after breakfast, lunch, and dinner. * If you cannot eat either breakfast or lunch, take 2 capsules of the test food at once after next meal within the day. If you cannot eat dinner, take the test food in the evening. * If you forget to take the capsule, take it as soon as you remember within the day.
Interventions/Control_2	Duration: 8 weeks Test material: Placebo capsule Dose: Take 3 capsules per day Administration: Take a capsule after breakfast, lunch, and dinner. * If you cannot eat breakfast or lunch, take 2 capsules of the test food at once after next meal within the day. If you cannot eat dinner, take the test food in the evening. * If you forget to take the capsule, take it as soon as you remember within the day.
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	1. Healthy Japanese adults 2. Subjects experiencing stress in daily 3. Subjects whose the result of the Helicobacter pylori antibody test is negative at screening and examination before ingestion and are judged as eligible to participate in the study by the principal investigator 4. Among the subjects who met 3rd inclusion criteria, subjects whose LF/HF ratio at autonomic function test is relatively high
Key exclusion criteria	1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases 3. Subjects who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily 4. Currently taking medicines (include herbal medicines) and supplements 5. Subjects who are allergic to medicines and/or the test food related products 6. Subjects who are pregnant, breast-feeding, and plan to become pregnant 7. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 8. Subjects who are judged as ineligible to participate in the study by the principal investigator 9. Subjects who have been diagnosed with Helicobacter pylori infection
Target sample size	40

Research contact person
Name of lead principal investigator	Kazuo YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
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	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	MITSUBISHI-CHEMICAL FOODS CORPORATION
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medical Corporation Seishinkai, 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) Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 11 Day
Anticipated trial start date	2017 Year 10 Month 17 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	2017 Year 10 Month 16 Day
Last modified on	2018 Year 07 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033794