UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052741 |
|---|---|
| Receipt number | R000060123 |
| Scientific Title | Confirmation of the effect of hydration in the body through the ingestion of research foods -A randomized, placebo controlled, single blind, three-period crossover comparative trial- |
| Date of disclosure of the study information | 2023/11/12 |
| Last modified on | 2023/12/25 15:08:59 |
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Basic information
Public title
Confirmation of the effect of hydration in the body through the ingestion of research foods
Acronym
Confirmation of the effect of hydration in the body through the ingestion of research foods
Scientific Title
Confirmation of the effect of hydration in the body through the ingestion of research foods
-A randomized, placebo controlled, single blind, three-period crossover comparative trial-
Scientific Title:Acronym
Confirmation of the effect of hydration in the body through the ingestion of research foods
-A randomized, placebo controlled, single blind, three-period crossover comparative trial-
Region
| Japan |
Condition
Condition
Healthy male adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of a single intake of a food ingredient on the rehydration of the body in males between the ages of 20 and 65.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Osmolality (serum, urine)
Key secondary outcomes
Blood tests, Urine tests, Urine volume, Body weight, body water balance, body temperature, blood pressure, pulse
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test food 1, equal to the same amount of body weight loss after sauna, is ingested once.
Interventions/Control_2
Test food 2, equal to the same amount of body weight loss after sauna, is ingested once.
Interventions/Control_3
Placebo food, equal to the same amount of body weight loss after sauna, is ingested once.
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
Key inclusion criteria
(1)Male subjects ranging in age from 20 to 65 at informed consent.
(2)Subjects ranging in BMI from 18.5 to less than 25.0 kg/m2.
(3)Subjects who can visit the designated facility on measurement days.
(4)Subjects who can use smartphones or PC to record a digital diary.
(5)Subjects who can make self-judgment and voluntarily gave written informed consent.
Key exclusion criteria
(1) with irregular life rhythm (e.g., irregular shift work).
(2) Heavily drinkers (40 g or more as pure alcohol).
(3) Subjects having a habit of smoking.
(4) Persons who regularly consume health foods or supplements such as foods for specified health uses or foods with functional claims that may affect the study, and cannot stop taking them after consent is obtained
(5) Subjects with a systolic blood pressure of less than 90 mmHg.
(6) Subjects who donated their blood components and/or whole blood (over 0.2 L) within the past 4 weeks.
(7) Subjects who donated their whole blood (over 0.4 L) within the past 12 weeks.
(8) Subjects being collected in total of their blood (over 1.2 L) within the past 12 months and in this research.
(9) Subjects being under other clinical tests, or participated in those within the past four weeks, or will join those after the consent.
(10) Subjects who meet any of the following:
(a) suffering from heart, liver, or kidney disease (including complications of other diseases)
(b) having a history of cardiovascular disease
(c) diabetes
(d) allergic to the test foods and/or required one.
(11) Persons who have difficulty collecting blood
(12) Those who have difficulty sweating in the sauna
(13) Persons who are unable to take a sauna bath for 10 minutes x 3 times
(14) People who do not like closed spaces and cannot enter a solo sauna
(15) Persons with extensive burn scars
(16) Persons with tattoos
(17) Those who are judged by the study director or study sub-physician to be unsuitable as study subjects.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Hisako |
| Middle name | |
| Last name | Minami |
Organization
Suntory beverage & Food limited.
Division name
Development & Designed Department
Zip code
2110067
Address
13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN
TEL
050-3182-6161
Hisako_Nakamura@suntory.co.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Matsuoka |
Organization
Suntory beverage & Food limited.
Division name
Development & Designed Department
Zip code
2110067
Address
13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN
TEL
05031820550
Homepage URL
Kaori_Matsuoka@suntory.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Suntory beverage & Food limited.
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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
n-yuzawa@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
医療法人社団 成守会 はせがわ病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 12 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2024 | 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 | 11 | Month | 09 | Day |
Last modified on
| 2023 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060123
| Research Plan | |
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| 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 |
