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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032097
Receipt No. R000036620
Scientific Title The Study of Long-Term (24-Week) Safety in Japanese Adult Men and Women with Intake of Food Containing Spearmint Extract
Date of disclosure of the study information 2018/12/20
Last modified on 2018/07/11

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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
Middle name
Last name Sumiyoshi Etsuko
Organization WAKASASEIKATSU Co.,Ltd.
Division name Marketing
Zip code
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
Middle name
Last name Ochitani Daisuke
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code
Address Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL 81-3-3431-1260
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
Address
Tel
Email

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
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
2018 Year 03 Month 09 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 04 Day
Last follow-up date
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
2018 Year 07 Month 11 Day


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

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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