UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047060 |
|---|---|
| Receipt number | R000053660 |
| Scientific Title | Effects of a research food on total body water |
| Date of disclosure of the study information | 2022/09/10 |
| Last modified on | 2022/09/07 08:32:33 |
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Basic information
Public title
Effects of a research food on total body water
Acronym
Effects of a research food on total body water
Scientific Title
Effects of a research food on total body water
Scientific Title:Acronym
Effects of a research food on total body water
Region
| Japan |
Condition
Condition
N/A(healthy adults)
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine effects of a research food on total body water.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total body water
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Single ingestion of the test food - single ingestion of the placebo food
Interventions/Control_2
Single ingestion of the placebo food - single ingestion of the test food
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Men and women aged 20 to 65 years at the time of obtaining consent.
2)BMI of 18.5 kg/m^2or more but less than 25.0 kg/m^2.
3)Those who have received sufficient explanation of the test, understand the contents, and can give written consent in person.
4) Those who have completed two doses of the new coronavirus vaccine.
Key exclusion criteria
1)Those who have current medical treatments, or who are planning some kind of treatment the test period.
2)Those who constantly use medicines that may affect test results.(diuretic, antidiuretic, etc.).Those who take health foods and supplements (oral rehydration solution, saw palmettoetc.) daily, and those who may take or take them during the test period.
3)Those who are scheduled to take medication or receive vaccinations between one week before the first test date and the second test date.
4)Those who may onset seasonal allergies such as hay fever and take medicines during test period.
5)Those who may change their lifestyle (night shift, long trip, etc.) during test period.
6)Heavy drinkers of alcohol.
7)Those who have a history or current history of serious diseases of the heart, liver, kidneys, digestive organs, etc.
8)Individuals with probable seasonal allergy, such as pollinosis, during the test period.
9) Those who are pregnant, lactating, or intend to become pregnant during the study period.
10)Those with allergies to medicines or food.
11)Those who are currently participating in a clinical trial of another drug or health food, and plan to participate in another clinical trial within 4 weeks of the end of the trial, or after consenting to participate in the trial.
12)Patients who are judged to be inappropriate for participation in the study by the principal investigator or sub-investigator.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Toshihiro |
| Middle name | |
| Last name | Kawama |
Organization
Morinaga & Co., Ltd.
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama
TEL
045-571-6140
t-kawama-jb@morinaga.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Morinaga |
Organization
Morinaga & Co., Ltd.
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama, Kanagawa
TEL
045-571-6140
Homepage URL
m-morinaga-bj@morinaga.co.jp
Sponsor or person
Institute
Morinaga & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Morinaga & 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.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
| 2022 | Year | 09 | Month | 10 | 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
| 2022 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 02 | Day |
Last modified on
| 2022 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053660
