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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040012
Receipt No. 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 2020/12/10

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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
Email naoko_tamura@naturally-plus.co.jp

Public contact
Name of contact person
1st name Naomi
Middle name
Last name Yuzawa
Organization imeQ RD inc.
Division name Sales department
Zip code 169-0051
Address 2-14-6, Nishi-Waseda, Shinjyuku, Tokyo
TEL 03-6205-6222
Homepage URL
Email n-yuzawa@imeqrd.co.jp

Sponsor
Institute imeQ RD inc.
Institute
Department

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 03-6205-6222
Email 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
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
2020 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045619

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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