UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050159 |
|---|---|
| Receipt number | R000057133 |
| Scientific Title | Evaluation of mineral absorption by consumption of test beverages |
| Date of disclosure of the study information | 2023/02/01 |
| Last modified on | 2023/01/27 12:09:14 |
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Basic information
Public title
Evaluation of mineral absorption by consumption of test beverages
Acronym
Evaluation of mineral absorption by consumption of test beverages
Scientific Title
Evaluation of mineral absorption by consumption of test beverages
Scientific Title:Acronym
Evaluation of mineral absorption by consumption of test beverages
Region
| Japan |
Condition
Condition
normal subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of consumption of test beverages on mineral absorption
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary Mineral Levels
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants 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
Consumption of test beverage -> (1 week) -> Consumption of control beverage
Interventions/Control_2
Consumption of control beverage -> (1 week) -> Consumption of test beverage
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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | > |
Gender
Female
Key inclusion criteria
1. women who are between 18 and 25 years of age at the time of agreement
2. who are capable of understanding and agreement with the study
3. who has agreed to participate in the study in writing of their own will after receiving an explanation of the purpose and content of the study.
Key exclusion criteria
1. who have a disease related to the mineral absorption or metabolism.
2. who have other serious diseases and are under treatment.
3. who frequently show diarrhea.
4. who are taking drugs related to mineral absorption or metabolism.
5. who take mineral supplement daily.
6. who may develop food allergies during the study.
7. who are pregnant or lactating.
8. who have excessive alcohol consumption habits (>60g/day).
9. who are deemed by the study investigator to be unappropriated to participate in the study.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Uenishi |
Organization
Kagawa Nutrition University
Division name
Laboratory of Physiological Nutrition
Zip code
350-0288
Address
3-9-21 chiyoda Sakado city Saitama prefecture
TEL
049-284-3895
uenishi@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Uenishi |
Organization
Kagawa Nutrition University
Division name
Laboratory of Physiological Nutrition
Zip code
350-0288
Address
3-9-21 chiyoda Sakado city Saitama prefecture
TEL
049-284-3895
Homepage URL
uenishi@eiyo.ac.jp
Sponsor or person
Institute
Kagawa Nutrition University
Institute
Department
Personal name
Funding Source
Organization
MEGMILK SNOW BRAND 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
The Human Research Ethics Committee of Kagawa Nutrition University
Address
3-9-21 chiyoda Sakado city Saitama prefecture
Tel
049-282-1353
kenshien@eiyo.ac.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
| 2023 | Year | 02 | Month | 01 | 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
12
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 01 | Month | 27 | Day |
Last modified on
| 2023 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057133
| 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 |
