UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046806 |
|---|---|
| Receipt number | R000053404 |
| Scientific Title | An evaluation of efficacy for blood flow and cold intolerance of test food intake. - A placebo-controlled, randomized, double-blind cross-over clinical trial - |
| Date of disclosure of the study information | 2022/02/04 |
| Last modified on | 2024/05/20 15:55:15 |
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Basic information
Public title
An evaluation of efficacy for blood flow and cold intolerance of test food intake. - A placebo-controlled, randomized, double-blind cross-over clinical trial -
Acronym
An evaluation of efficacy for blood flow and cold intolerance of test food intake.
Scientific Title
An evaluation of efficacy for blood flow and cold intolerance of test food intake. - A placebo-controlled, randomized, double-blind cross-over clinical trial -
Scientific Title:Acronym
An evaluation of efficacy for blood flow and cold intolerance of test food intake.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This trial aims to investigate the effect of the test food intake on the blood flow and cold intolerance.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood flow
Key secondary outcomes
Body surface temperature
Questionnaire for subjective evaluation
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take two capsules of test food A with cold water once at a visit.
Interventions/Control_2
Take two capsules of test food B with cold water once at a visit.
Interventions/Control_3
Take two capsules of placebo food with cold water once at a visit.
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 between 20 and 65 years old at the time of informed consent
2. Japanese male or female
3. Those who is aware of own cold intolerance
4. BMI under 30 kg/m2
5. Those who are able to input electronic diary with smartphone or PC
6. Those who received the sufficient explanation for the objective and summary of the trial, voluntarily decided to participate in the trial after understanding the purpose and made the written agreement
Key exclusion criteria
1. Those who have been currently visiting a hospital or treated with any drug or herbal remedy for any disease
2. Those who are on diet/exercise therapy under the guidance of a doctor
3. Those who currently have or have history of severe diseases
4. Those who have serious anemia
5. Those who daily take medicine, quasi-medicine, food for specified health uses or nutritional supplements / foods on the market that have health claims related to fatigue, stress relief, cold intolerance, blood flow, blood pressure or calefacient (excluding individuals who can refrain from ingestion after receiving informed consent until the end of the study)
6. Those who are using any machine related to fatigue, stress relief, cold intolerance, blood flow, blood pressure or calefacient (excluding individuals who can refrain from the use after the informed consent until the end of the study)
7. Those who currently have or have a history of drug and/or food allergies
8. Those who have smoked within a year
9. Males who have donated more than 400 mL of the blood within 3 months before receiving informed consent
10. Females who have donated more than 200 mL of the blood within 3 months before receiving informed consent
11. Those who have plans of major change on their lifestyle (e.g., diet, sleep and exercise) during the study period
12. Those who have daily exercise such as jogging and muscle training
13. Those who are engaged in night work or spilt shift
14. Those who are planning to travel abroad during the study period
15. Those who are currently pregnant, breastfeeding or planning to get pregnant during the study period.
16. Those who joined other clinical trials since 1 month before receiving informed consent in this study, or those who are currently joining other clinical trials
17. Those who are judged by the physician to be unsuitable for this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masamitsu |
| Middle name | |
| Last name | Moriwaki |
Organization
Taiyo Kagaku Co., Ltd
Division name
Nutrition Division
Zip code
512-1111
Address
800 Yamada-cho, Yokkaichi, Mie Japan
TEL
059-340-0800
mmoriwaki@taiyokagaku.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
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
Taiyo Kagaku 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 | 04 | 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
20
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 | 18 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 04 | 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 | 02 | Month | 02 | 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=R000053404
