UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046745 |
|---|---|
| Receipt number | R000053322 |
| Scientific Title | An exploratory study on the effect of continuous intake of test food on vascular functions. -a single-arm, open-label trial- |
| Date of disclosure of the study information | 2022/02/08 |
| Last modified on | 2024/05/20 15:57:17 |
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Basic information
Public title
An exploratory study on the effect of continuous intake of test food on vascular functions. -a single-arm, open-label trial-
Acronym
An exploratory study on the effect of continuous intake of test food on vascular functions
Scientific Title
An exploratory study on the effect of continuous intake of test food on vascular functions. -a single-arm, open-label trial-
Scientific Title:Acronym
An exploratory study on the effect of continuous intake of test food on vascular functions
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effect of continuous intake of test food for 4-weeks on vascular functions in healthy males and females aged between 30 and less than 59 years old.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire for physical health
Assessment of vascular functions
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
Take two tablets of the test food with water or warm water after breakfast once a day.
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
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Aged between 30 and less than 59 years old.
2. Japanese males and females.
3. Those who feel body coldness, fatigue, or any mental/physical stress all the time.
4. Those who can use smartphones or PCs to input an electronic diary.
5. Those who received sufficient explanation for the objective and summary of the trial, and also voluntarily volunteered to the trial with the agreement of informed consent.
Key exclusion criteria
1. Those who are currently undergoing treatment for any disease, or who receive medical treatment such as medical drugs or traditional Chinese medicines. However, medications used as needed will be allowed to join the trial.
2. Those who have been receiving nutritional and exercise therapy under medical doctors.
3. Those who have severe diseases or a history of severe diseases.
4. Those who have severe anemia.
5. Those who have currently been taking commercially available drugs, quasi-drug products, foods, or supplements with any functional claims. However, Those who can discontinue taking these drugs/foods during the trial period will be allowed to join the trial.
6. Those who have currently been utilizing any medical machines, such as warmth medical treatment, to improve fatigue, mental/physical stress, coldness, blood flow, blood pressure. However, Those who can discontinue using these machines during the trial period will be allowed to join the trial.
7. Those who have a cold allergy, a drug allergy, or a food allergy.
8. Those who smoke within one year before the trial.
9. Those who drink more than 60 g alcohol/day.
10. Women who have abnormal menstrual periods, or during menstruation on the day of visit.
11. Those who donated blood more than 400 mL (men) or 200 mL (women) within three months before the trial.
12. Those who are planning extremely change their lifestyle (such as diet, sleep, or exercise) during the study period.
13. Those who work in shift and night shift.
14. Those who are planning travel to foreign countries during the study period.
15. Those who are currently pregnant or breastfeeding, or planning to pregnant during the study period.
16. Those who joined other clinical trials from one month before the trial, or Those who have currently been joined other clinical trials. Also, Those who are planning to join other clinical trials during the trial.
17. Those who are unsuitable for this study, that judged by the principal investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Igari |
Organization
Daiwa Pharmaceutical Co., Ltd.
Division name
Department of Research and Development
Zip code
154-0024
Address
1-16-19 Sangenjaya, Setagaya-Ku, Tokyo, 154-0024, Japan
TEL
03-5430-4050
igari@daiwa-pharm.com
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co, Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
https://imeqrd.co.jp/
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Daiwa Pharmaceutical 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.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
| 2022 | Year | 02 | Month | 08 | 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
Completed
Date of protocol fixation
| 2022 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 27 | Day |
Last modified on
| 2024 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053322
