UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029582
Receipt No. R000033794
Scientific Title The verification study of improvements in psychological stress: a randomized double-blind, parallel-group, placebo-controlled trial
Date of disclosure of the study information 2017/10/16
Last modified on 2018/07/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The verification study of improvements in psychological stress: a randomized double-blind, parallel-group, placebo-controlled trial
Acronym The verification study of improvements in psychological stress
Scientific Title The verification study of improvements in psychological stress: a randomized double-blind, parallel-group, placebo-controlled trial
Scientific Title:Acronym 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
1st name
Middle name
Last name Kazuo YAMAMOTO
Organization ORTHOMEDICO Inc.
Division name CEO
Zip code
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
1st name
Middle name
Last name Naoko SUZUKI
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code
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)

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 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

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 Completed
Date of protocol fixation
2017 Year 10 Month 11 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.