UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032097 |
|---|---|
| Receipt number | 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 | 2021/06/07 09:34:02 |
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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 | 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
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
ochitani@huma-c.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036620
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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