UMIN-CTR Clinical Trial

Basic information
Public title	A Study on the Effect of Food Containing Plant Extract on QOL -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Acronym	A Study on the Effect of Food Containing Plant Extract on QOL
Scientific Title	A Study on the Effect of Food Containing Plant Extract on QOL -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Scientific Title:Acronym	A Study on the Effect of Food Containing Plant Extract on QOL
Region	Japan

Condition
Condition	No
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the effect of food containing plant extract on QOL
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	QOL questionnaire
Key secondary outcomes	complexion

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Foods containing plant extract, 4 weeks consumption
Interventions/Control_2	Foods not containing plant extract, 4 weeks consumption
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1)Healthy Japanese males and females aged 20 to 64 years-old. 2)Subjects who tend to feel tired easily in daily life. 3)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria	Subjects (who) 1)are judged by doctors to have a high probability of chronic fatigue syndrome. 2)contract or are under treatment for serious diseases (e.g., liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, and/or other metabolic disease). 3)have a chronic disease and use medications. 4)contract or have a surgical history of digestive disease affecting digestion and absorption. 5)may have allergy to test foods. 6)have alcohol intake more than approximately 20 g/day of pure alcohol equivalent or a habit of drinking not less than 4 days a week. 7)can't stop drinking from 2 days before each measurement. 8) smoke 10 or more cigarettes a day, or cannot quit smoking during from waking to inspection completed. 9)use drugs, supplements, or functional foods associated with fatigue recovery. 10)are shiftworker, midnight worker and/or hard worker. 11)have regular hard exercise. 12) are pregnant or breast-feeding or planned to become pregnant during the study period. 13) have donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study. 14)are participating in or willing to participate in other clinical studies. 15)are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Kayoko Middle name Last name Numano
Organization	Ebisu Ray Clinic, Shinkoukai Medical Corporation
Division name	Dermatology
Zip code	150-0013
Address	1-11-2 Ebisu, Shibuya-ku, Tokyo
TEL	03-6277-3917
Email	kaco@yahoo.co.jp

Public contact
Name of contact person	1st name Yoshika Middle name Last name Komori
Organization	KSO Corporation
Division name	Sales department
Zip code	105-0023
Address	1-9-7 Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	eigyou27@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	TOYO SHINYAKU Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	General Incorporated Association Clinical Research Review Center
Address	2972-8-603 Ishikawacho, Hachiouji-shi, Tokyo
Tel	090-3547-6398
Email	crrctakashima@kpd.biglobe.ne.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

Other administrative information
Date of disclosure of the study information	2021 Year 05 Month 14 Day

Related information
URL releasing protocol	https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000050439
Publication of results	Published

Result
URL related to results and publications	http://www.pieronline.jp/content/article/0386-3603/49120/2127
Number of participants that the trial has enrolled	50
Results	Statistically significant difference was confirmed in the primary outcome.
Results date posted	2022 Year 03 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Males and females aged 20 to 64years old.
Participant flow	Enrolled(n=50) Completed(n=50) Analysed(n=35)
Adverse events	No adverse events were observed that be related to test food.
Outcome measures	QOL questionnaire
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2021 Year 04 Month 12 Day
Date of IRB	2021 Year 04 Month 21 Day
Anticipated trial start date	2021 Year 05 Month 15 Day
Last follow-up date	2021 Year 07 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 05 Month 12 Day
Last modified on	2022 Year 03 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050439