UMIN-CTR Clinical Trial

Basic information
Public title	The Study of Long-Term (24-Week) Safety in Japanese Adult Men and Women with Intake of Food Containing Spearmint Extract
Acronym	The Study of Long-Term (24-Week) Safety in Japanese Adult Men and Women with Intake of Food Containing Spearmint Extract
Scientific Title	The Study of Long-Term (24-Week) Safety in Japanese Adult Men and Women with Intake of Food Containing Spearmint Extract
Scientific Title:Acronym	The Study of Long-Term (24-Week) Safety in Japanese Adult Men and Women with Intake of Food Containing Spearmint Extract
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the safety of long term (24-week) administration of foods containing spearmint extract in healthy Japanese men and women(aged 20-65 years).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hematology, clinical chemistry profile, systolic blood pressure, diastolic blood pressure, pulse rate, BMI, urinalysis, adverse events
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Long-term (24-week) administration of the foods containing spearmint extract
Interventions/Control_2
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)Age:20 years and over, under 65 years old 2)Gender:Japanese males and females 3)Persons eating three meals a day
Key exclusion criteria	1)Persons currently receiving any medication or outpatient treatment 2)Persons with a history of liver disease or serious renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological and metabolic diseases or complications 3)Persons with a history of drug or food allergy 4)Currently, supplements containing polyphenols (Ginkgo biloba extract, bilberry extract, blueberry extract, cassis extract, acai extract, maxiberry extract, catechin, theaflavine, coconut extract, grape and stem extract, melin jo extract, propolis, turmeric extract, rosemary extract, lemonberm extract, lavender extract, time extract, and sito extract) are taken, and people who are unable to discontinue or plan to drink the supplement by 15 days prior to the start of spearmint extract 5)Patients who are unable to discontinue taking supplements containing rosmarinic acid as the main ingredient (lemonbalm, rosemary, peppermint, perilla, etc.) 6)Individuals with extreme predation 7)Extremely irregular lifestyle, such as eating or sleeping 8)Persons with sleep disorders (e.g., insomnia, sleep apnea syndrome) 9)Persons with a current or past history of psychiatric disorders (e.g., depression) 10)Persons with a current or past history of alcoholism 11)Subjects who are currently participating in other clinical studies or have participated in other clinical studies within the past 3 months 12)Persons with irregular working hours, such as night shifts 13)Other subjects who are considered inappropriate for inclusion in the study by the investigator
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Etsuko Middle name Last name Sumiyoshi
Organization	WAKASASEIKATSU Co.,Ltd.
Division name	Marketing
Zip code	104-0028
Address	PRAIRIE YAESU BUILDING 8F 2-5-12 Yaesu Chuo-ku Tokyo 104-0028 Japan
TEL	03-6262-5133
Email	etsuko_sumiyoshi@blueberryeye.co.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Zip code	1080014
Address	Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Homepage URL
Email	ochitani@huma-c.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	WAKASASEIKATSU 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	Ethics Committees of Nihonbashi Egawa Clinic
Address	2F Kotobuki Build. 1-27-12 Yaesu Chuo-ku, Tokyo 103-0028 Japan
Tel	03-5204-0311
Email	jim@medipharma.co.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	2018 Year 12 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	18
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	2018 Year 03 Month 09 Day
Date of IRB	2018 Year 03 Month 09 Day
Anticipated trial start date	2018 Year 04 Month 04 Day
Last follow-up date	2018 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 04 Month 04 Day
Last modified on	2021 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036620