UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031443
Receipt No. 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 2018/02/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email sugino@soiken.com

Sponsor
Institute Soiken Inc.
Institute
Department

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
Email

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 Preinitiation
Date of protocol fixation
2018 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 24 Day
Last follow-up date
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
2018 Year 02 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035901

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.