UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031443 |
|---|---|
| Receipt number | R000035901 |
| Scientific Title | A clinical study to evaluate the effects of dextrin on maintaining hydration status |
| Date of disclosure of the study information | 2018/02/23 |
| Last modified on | 2023/08/29 11:37:10 |
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Basic information
Public title
A clinical study to evaluate the effects of dextrin on maintaining hydration status
Acronym
A clinical study to evaluate the effects of dextrin on maintaining hydration status
Scientific Title
A clinical study to evaluate the effects of dextrin on maintaining hydration status
Scientific Title:Acronym
A clinical study to evaluate the effects of dextrin on maintaining hydration status
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of the intake of beverage containing dextrin on maintaining hydration status in a randomized, double-blind, placebo-controlled, crossover study
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of water absorption
Key secondary outcomes
Water retention, Changes of blood glucose
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of test food -> Washout for 1 week -> Intake of Placebo
Interventions/Control_2
Intake of Placebo -> Washout for 1 week -> Intake of 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
| 55 | years-old | > |
Gender
Male
Key inclusion criteria
1) Subjects whose age of 20 years or more and less than 55 years
2) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntary participate in the study and being able to personally sign a written informed consent
Key exclusion criteria
1) Subjects having serious hepatic, cardio-vascular, respiratory, endocrine or metabolic disorders
2) Subjects who have a seasonal allergic rhinitis (cedar or Japanese cypress pollen) with moderate or severe symptoms
3) Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood)
4) Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study
5) Subjects deemed unsuitable by the investigator
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Terada |
Organization
EZAKI GLICO CO., LTD.
Division name
Institute of Health Sciences
Zip code
Address
4-6-5, Utajima, Nishiyodogawa-ku, Osaka
TEL
06-6477-8425
terada-yoshinobu@glico.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiro Sugino |
Organization
Soiken Inc.
Division name
Representative Director
Zip code
Address
Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
TEL
06-6871-8888
Homepage URL
sugino@soiken.com
Sponsor or person
Institute
Soiken Inc.
Institute
Department
Personal name
Funding Source
Organization
EZAKI GLICO 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
Address
Tel
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
| 2018 | Year | 02 | Month | 23 | 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
| 2018 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 23 | Day |
Last modified on
| 2023 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035901
