UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054796 |
|---|---|
| Receipt number | R000062569 |
| Scientific Title | Evaluation of nutritional changes in urine due to intake of health foods |
| Date of disclosure of the study information | 2024/06/27 |
| Last modified on | 2025/01/06 11:56:21 |
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Basic information
Public title
Evaluation of nutritional changes in urine due to intake of health foods
Acronym
Evaluation of nutritional changes in urine due to intake of health foods
Scientific Title
Evaluation of nutritional changes in urine due to intake of health foods
Scientific Title:Acronym
Evaluation of nutritional changes in urine due to intake of health foods
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
After consuming healthy foods for a certain period of time, a simple rapid urine test will be conducted on healthy men and women to verify the effects on urinary excretion of items that can be evaluated using urine test strips.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary nutrient excretion before and after ingestion of health foods (Kadani Euglena Refreshing Green Tea Flavor, DHC Multivitamin Supplement, DHC Multimineral Supplement, Dear Natura Style Coenzyme Q10, Calvert)
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Consume healthy foods in the amount recommended by the manufacturer for one week, followed by a one-week washout period. This operation is carried out for five types of health foods.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who meet the purpose of the test based on the background investigation (confirmation of gender, age, allergies, presence of chronic diseases, etc.)
Persons who are 20 years of age or older at the time of obtaining consent
Key exclusion criteria
Those who are allergic to the test food or dislike the test food.
Persons who regularly consume foods containing the same ingredients as the test food and are unable to stop consuming them during the test period.
Persons who are at risk of exhibiting allergic symptoms, such as those with a history of chemical sensitivity.
Those who take medicines on a daily basis
In addition, those who are judged by the research director to be unsuitable as research participants.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Keitaro |
| Middle name | |
| Last name | Hagiwara |
Organization
Yuurea Co., Ltd.
Division name
Research director
Zip code
451-0000
Address
Meieki Diamatetsu Building 11F, 1-1-17 Meieki, Nishi-ku, Nagoya, Aichi Prefecture
TEL
080-5055-3551
hagiwara.keitaro@yuurea.co.jp
Public contact
Name of contact person
| 1st name | Keitaro |
| Middle name | |
| Last name | Hagiwara |
Organization
Yuurea Co., Ltd.
Division name
Research director
Zip code
451-0000
Address
Meieki Diamatetsu Building 11F, 1-1-17 Meieki, Nishi-ku, Nagoya, Aichi Prefecture
TEL
080-5055-3551
Homepage URL
hagiwara.keitaro@yuurea.co.jp
Sponsor or person
Institute
Yuurea Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Euglena 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
Research Ethics Review Committee
Address
Meieki Diamatetsu Building 11F, 1-1-17 Meieki, Nishi-ku, Nagoya, Aichi Prefecture
Tel
080-5055-3551
hagiwara.keitaro@yuurea.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
| 2024 | Year | 06 | Month | 27 | 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
| 2024 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2024 | Year | 06 | Month | 27 | Day |
Last modified on
| 2025 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062569
