UMIN-CTR Clinical Trial

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	Completed
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	2022 Year 04 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042300