UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040012 |
|---|---|
| Receipt number | R000045619 |
| Scientific Title | A study of carotenoid levels in the body after continuous intake of test food. |
| Date of disclosure of the study information | 2020/03/31 |
| Last modified on | 2024/05/21 14:42:18 |
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Basic information
Public title
A study of carotenoid levels in the body after continuous intake of test food.
Acronym
A study of carotenoid levels in the body after continuous intake of test food.
Scientific Title
A study of carotenoid levels in the body after continuous intake of test food.
Scientific Title:Acronym
A study of carotenoid levels in the body after continuous intake of test food.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to observe carotenoid levels in the body and antioxidant action of carotenoids in men and women aged 20-59 who took test food or placebo.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Carotenoid levels
Key secondary outcomes
8-OHdG (8-hydroxy-2'-deoxyguanosine), SOD(superoxide dismutase), PAO (potential antioxidant), skin moisture, and skin elasticity
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 4 test food tablets once daily with a glass of water or lukewarm water after having dinner.
Interventions/Control_2
Take 4 placebo food tablets once daily with a glass of water or lukewarm water after having dinner.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. 20 to 59 years old
2. Male and females.
3.Those who consider themselves insufficient in vegetable intake.
4. Smartphone or PC users (who can input their own data into the electronic diary).
5. Those who do not change or do not intend to change daily life habits during the study period.
6. Those who can provide their written informed consent.
Key exclusion criteria
1. Those who are currently receiving drug treatment of chronic illness.
2. Those who are receiving nutrition therapy or physical therapy under a doctor's supervision.
3. Those who have a current or a past medical history of severe diseases.
4. Those who have a past and current medical history of drug or food allergy.
5. Those who started taking any of the following products in the past three months: drugs, quasi-drug products, Foods with Health Claim (Foods for Specified Health Use, in particular), health foods, and supplements, and also those who have been routinely taking these products. Those who intend to take these products during the study period.
6. Heavy drinkers.
7. Smokers.
8. Those who work night shifts.
9. Those who are currently undergoing treatment for drug dependence or drug abuse or those who have a past medical history of either of them.
10. Those who cannot stop drinking alcohol the day before the test.
11. Those who cannot follow a restrictive diet which starts at 10:00 pm on the day before the test.
12. Those who are currently pregnant or breastfeeding or those who want to become pregnant during the study period.
13. Those who are currently participating in another clinical trial or those who took a test product and completed another clinical trial in a month.
14. Those who were determined by the principal investigator and the sub investigator to be unsuitable for participation in this clinical trial.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Naoko |
| Middle name | |
| Last name | Tamura |
Organization
Naturally Plus Co.,Ltd.
Division name
Corporate Communication Div.
Zip code
106-6035
Address
Izumi garden tower 35F 1-6-1,Roppongi,Minato-ku,Tokyo
TEL
03-6230-2745
naoko_tamura@naturally-plus.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
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Naturally Plus Co.,Ltd.
Organization
Division
Category of Funding Organization
Self funding
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
| 2020 | Year | 03 | 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
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2020 | Year | 07 | 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
| 2020 | Year | 03 | Month | 31 | Day |
Last modified on
| 2024 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045619
