UMIN-CTR Clinical Trial

Basic information
Public title	Effect of taking foods containing natural products on mental and physical health in adult women
Acronym	The effect test of taking foods containing natural products
Scientific Title	Effect of taking foods containing natural products on mental and physical health in adult women
Scientific Title:Acronym	The effect test of foods containing natural products
Region	Japan

Condition
Condition	Healthy adult women
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of foods containing natural products on mental and physical health in adult women in healthy adult women
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Skin quality measurement
Key secondary outcomes	Visual Analog scale of skin condition Profile of Mood States 2nd Edition Dermatology Life Quality Index OSA sleep inventory MA version Pittsburgh Sleep Quality Index Bodyweight Body fat percentage Health record Saliva test

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	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	To take food containing natural products 1 packet/ day for 4 weeks
Interventions/Control_2	To take a placebo food 1 packet/ day for 4 weeks
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	40 years-old <=
Age-upper limit	65 years-old >=
Gender	Female
Key inclusion criteria	(1) persons who is generally judged as healthy (2) Persons who can give voluntary written consent to participate in the present trial
Key exclusion criteria	(1)persons who have any dietary supplements, quasi drugs or medicines which cause same or similar efficacy with the effect evaluated in this study (2)persons who have changed their habitats to take supplements within past 4 weeks. (3)Persons who work in night shift or in day and night shift (4)persons who have been treated their illness or prevention in a clinic at their informed consent (5)persons with their medical histories as follows: serious diseases of sugar metabolism, lipid metabolism, hepatic function, renal function, heart, circulatory, respiratory, endocrine system, immune system, or mental illness of the nervous system (6)persons with the medical histories of alcoholism or drug dependence (7)persons who might be developed allergic reaction to foods. (8)Persons who are pregnant, breast-feeding, or hope to be pregnant during the study period (9)persons who had always participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device) (10)persons who will not be judged suitable to the participants by the investigator.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Koichiro Middle name Last name Ohnuki
Organization	Graduate School of Kindai university
Division name	Food Functional Laboratory
Zip code	820-8555
Address	11-6,Kayanomori,Iizuka,Fukuoka, JAPAN
TEL	0948-22-5655
Email	ohnuki@fuk.kindai.ac.jp

Public contact
Name of contact person	1st name Keiko Middle name Last name Ohnuki
Organization	Faculty of Humanity-Oriented Science and Engineering,Kindai University
Division name	Research and Development Department
Zip code	820-0115
Address	372-3,Niho,Iizuka Fukuoka, JAPAN
TEL	0948-82-3123
Homepage URL
Email	userlifescience@gmail.com

Sponsor
Institute	Faculty of Humanity-Oriented Science and Engineering,Kindai University
Institute
Department

Funding Source
Organization	Dr.PROLABO JAPAN Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Laboratory of Systematic Forest and Forest Products Science Faculty of Agriculture,Kyushu University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Graduate School of Kindai university,Ethics Committee
Address	11-6,Kayanomori,Iizuka,Fukuoka, JAPAN
Tel	0948-22-5655
Email	ohnuki@fuk.kindai.ac.jp

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	九州大学農学研究院　環境農学部門　森林圏環境資源科学研究室

Other administrative information
Date of disclosure of the study information	2023 Year 11 Month 19 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	Preinitiation
Date of protocol fixation	2022 Year 09 Month 26 Day
Date of IRB	2022 Year 03 Month 25 Day
Anticipated trial start date	2022 Year 10 Month 17 Day
Last follow-up date	2022 Year 11 Month 19 Day
Date of closure to data entry	2022 Year 12 Month 03 Day
Date trial data considered complete	2022 Year 12 Month 19 Day
Date analysis concluded	2023 Year 01 Month 19 Day

Other
Other related information

Management information
Registered date	2022 Year 09 Month 24 Day
Last modified on	2022 Year 10 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055834