UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052539 |
|---|---|
| Receipt number | R000059950 |
| Scientific Title | Effect of intake of Long pepper extract on capillary. |
| Date of disclosure of the study information | 2023/10/18 |
| Last modified on | 2024/04/17 09:56:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of intake of Long pepper extract on capillary.
Acronym
Effect of intake of Long pepper extract on capillary.
Scientific Title
Effect of intake of Long pepper extract on capillary.
Scientific Title:Acronym
Effect of intake of Long pepper extract on capillary.
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of intake of functional food for 4 weeks on capillary in healthy males and females aged 50 to 64 years.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Angiopoietin2 in blood
Status of capillary
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
Oral intake of test food (Once a day; 4 weeks).
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
| 50 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document.
2. Japanese males and postmenopausal females aged 50 - 64years, at the time of obtaining consent to participate.
3. Persons whose BMI is more than 23.0 kg/m2 and less than 30.0 kg/m2
Key exclusion criteria
1.Persons who have chronic diseases are currently suffering from any disease, are undergoing treatment, or have a history of any disease. 2.Persons who have a habit of taking medication for the purpose of disease treatment in the past month (except for a history of taking medication for headache, common cold, etc.). Persons who regularly use medicines or quasi-drugs for purposes other than the treatment of diseases. 3.Persons who are allergic to the test food, may have allergic symptoms to other foods or medicines. 4.Persons who regularly take a large amount of the test food, cinnamon, and rooibos tea. 5.Persons who regularly use medicines or health functional foods (food for specified health use, food with functional claims and nutrient functional food) that may affect the capillary morphology. 6.Persons with severe anemia symptoms. 7.Persons with dental or oral problems (periodontal disease, mouth ulcers, etc.) that cause bleeding. 8.Persons whose daily alcohol consumption exceeds 20 g of pure alcohol equivalent per day per day. 9.Persons whose lifestyle may change during the examination period (e.g., night work, extended travel, exercise, etc.). 10.Persons who habitually engage in strenuous exercise such as running, marathons, volleyball. 11.Persons who are unable to discontinue nail polish or fake fingernails during the examination period. 12.Persons who have donated over 200 mL of blood in the past month or over 400 mL within the past 3 months. 13.Persons who have experienced feeling unwell or deterioration of physical condition due to blood collection in the past. 14.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam. 15.Persons who were judged as inappropriate for study participants by the principal investigator. 16.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Suzuka |
| Middle name | |
| Last name | Oyama |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Park Place 5F, 5-27-1 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
oyama.suzuka@hc-sys.jp
Public contact
Name of contact person
| 1st name | Suzuka |
| Middle name | |
| Last name | Oyama |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Park Place 5F, 5-27-1 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
Homepage URL
oyama.suzuka@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Maruzen Pharmaceuticals 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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, JAPAN
Tel
052-734-8885
soumu@hc-sys.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
| 2023 | Year | 10 | Month | 18 | 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
9
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
| 2023 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2023 | Year | 10 | Month | 18 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059950
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
