UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043151 |
|---|---|
| Receipt number | R000049241 |
| Scientific Title | Study to investigate the effect of continuous intake on physiological changes --double-blind parallel-group comparative study-- |
| Date of disclosure of the study information | 2021/05/31 |
| Last modified on | 2021/04/02 17:50:57 |
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Basic information
Public title
Study to investigate the effect of continuous intake on physiological changes
--double-blind parallel-group comparative study--
Acronym
Study to investigate the effect of continuous intake on physiological changes
Scientific Title
Study to investigate the effect of continuous intake on physiological changes
--double-blind parallel-group comparative study--
Scientific Title:Acronym
Study to investigate the effect of continuous intake on physiological changes
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of continuous intake of test food for 8 weeks on physiological changes in men and women aged between 30 and 70 years
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical condition questionnaire
Physiological function evaluation questionnaire
Key secondary outcomes
Immune markers
Body temperature
Base
Study type
Interventional
Study design
Basic design
Parallel
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take 2 tablets of test food daily with water after breakfast
Interventions/Control_2
Take 2 tablets of placebo daily with water after breakfast
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Aged between 30 and 70 years
2. Japanese male or female
3. Participants who are able to input electronic diary with smartphone / PC.
4. Those who received sufficient explanation about the trial, volunteered to participate after understanding the purpose, and agree to participate in the trial with written consent.
Key exclusion criteria
1. treated with some immunosuppressant, anticancer drug, or drugs that affect immune function
2. under diet or exercise therapy under the supervision of a doctor
3. current or history of serious disease
4. taking lactic acid bacteria products and bifidobacteria products regularly
5. consumption of quasi-drug, food for specified health use, heatlh food or supplement (subjects who can stop taking those after providing consent are acceptable)
6. treatment for serious drug allergies or food allergies
7. participation in another clinical trial within one month before providing consent, participating currently or planning to participate
8. planning to significantly change their lifestyle (diet, sleep, exercise, etc.) during the trial
9. planning to go to abroad
10. pregnant or lactating, or willing to be pregnant during the trial
11. judged by the investigator to be unsuitable for participating in this study
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kuno |
Organization
DENSO Corporation
Division name
Food value Chain Biz Development Dpt.
Zip code
448-8661
Address
1-1 Shouwa-cho Kariya City Aichi
TEL
0566-20-3796
Hitoshi.kuno.j7c@jp.denso.com
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD inc.
Division name
Sales department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo
TEL
03-6704-5968
Homepage URL
h-kayama@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD inc.
Institute
Department
Personal name
Funding Source
Organization
DENSO Corporation
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
03-3207-8161
suda-clinic_irb@imeq.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
| 2021 | Year | 05 | Month | 31 | 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
Terminated
Date of protocol fixation
| 2021 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2021 | Year | 05 | 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
| 2021 | Year | 01 | Month | 27 | Day |
Last modified on
| 2021 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049241
| 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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| Registered date | File name |
