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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037121
Receipt No. R000042300
Scientific Title Effects of consumption of the test food on psychological stress of Japanese women aged 30 or over to under 70: A randomized double-blind placebo-controlled trial
Date of disclosure of the study information 2019/06/20
Last modified on 2019/10/25

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Basic information
Public title Effects of consumption of the test food on psychological stress of Japanese women aged 30 or over to under 70
Acronym Effects of consumption of the test food on psychological stress of Japanese women aged 30 or over to under 70
Scientific Title Effects of consumption of the test food on psychological stress of Japanese women aged 30 or over to under 70: A randomized double-blind placebo-controlled trial
Scientific Title:Acronym Effects of consumption of the test food on psychological stress of Japanese women aged 30 or over to under 70
Region
Japan

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

Objectives
Narrative objectives1 To verify the effects of the test food on psychological stress and other subjective symptoms on the healthy Japanese women aged 30 or over to under 70
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. Low Frequency (LF)/High Frequency (HF) ratio

* Assess the measured value at screening (before consumption) and at 4 and 12 weeks after consumption and calculate the amount of change.
Key secondary outcomes 1. LF
2. HF
3. Average heart rate
4. Maximum heart rate
5. Minimum heart rate
6. TP (total power)
7. ccvTP (coefficient of component variance total power)
8. Deviation value of autonomic function
9. Autonomic functional age
10. Salivary cortisol level
11. Serum crosslinked N-telopeptide of type I collagen
12. Blood serotonin level
13. Serum progesterone level
14. Serum estradiol level
15. Urinary deoxypyridinoline (DPD)
16. Simplified Menopausal Index (SMI)
16-1. SMI
16-2. Each question
17. Profile of Mood States 2nd Edition (POMS2) Japanese version
17-1. Each item of the mood symptoms
17-2. Each question
18. Questionnaire (the Likert scale)

* 1-18 Assess the measured value at screening (before consumption) and at 4 and 12 weeks after consumption and calculate the amount of change.

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 Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration: 12 weeks
Test food: Tablets containing sparassis crispa
Administration: Take three tablets per day after breakfast with water

* If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2 Duration: 12 weeks
Test food: Placebo tablets
Administration: Take three tablets per day after breakfast with water

* If you forget to take the test food, 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
30 years-old <=
Age-upper limit
70 years-old >
Gender Female
Key inclusion criteria 1. Healthy subjects

2. Japanese women aged >=30 to <70
Key exclusion criteria 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction

2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Subjects who are diagnosed with menopausal syndrome

5. Subjects who receive hormonal therapy

6. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily

7. Currently taking medicines (include herbal medicines) and supplements

8. Subjects who are allergic to medicines and/or the test food related products, particularly mushroom

9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial

10. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Kazuo
Middle name
Last name YAMAMOTO
Organization ORTHOMEDICO Inc.
Division name CEO
Zip code 112-0002
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 Naoko
Middle name
Last name SUZUKI
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code 112-0002
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 INTERTRADE Co., Ltd.
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 The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address 9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel 03-5793-3623
Email info@takara-clinic.com

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
2019 Year 06 Month 20 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 66
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 No longer recruiting
Date of protocol fixation
2019 Year 06 Month 10 Day
Date of IRB
2019 Year 06 Month 10 Day
Anticipated trial start date
2019 Year 06 Month 21 Day
Last follow-up date
2020 Year 02 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 20 Day
Last modified on
2019 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042300

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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