UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033464 |
|---|---|
| Receipt number | R000038159 |
| Scientific Title | Effects of palatinose drink ingestion on post-exercise fluid and thermoregulatory responses in humans |
| Date of disclosure of the study information | 2018/07/21 |
| Last modified on | 2019/09/25 19:04:26 |
* 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
Effects of palatinose drink ingestion on post-exercise fluid and thermoregulatory responses in humans
Acronym
Post-exercise palatinose drink ingestion
Scientific Title
Effects of palatinose drink ingestion on post-exercise fluid and thermoregulatory responses in humans
Scientific Title:Acronym
Post-exercise palatinose drink ingestion
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the influence of palatinose drink ingestion on fluid and thermoregulatory responses during post-exercise resting humans.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma volume
Key secondary outcomes
core temperature, sweat rate, skin blood flow
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
Post exercise water ingestion
Interventions/Control_2
Post exercise ingestion of 1 % palatinose drink
Interventions/Control_3
Post exercise ingestion of 6 % palatinose drink
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
| Not applicable |
Gender
Male
Key inclusion criteria
1) Aged over 20 yrs
Key exclusion criteria
1) Smoker, obese individuals
2) Individuals experienced any cardiovascular disease
3) Individuals with cardiac arrhythmia
4) Individuals with asthma
5) Individuals with gastrointestinal disease
6) Individuals with epilepsy
7) Individuals taking any medications drugs
8) Individuals experienced fainting during blood sampling
9) Individuals who are unable to self-blood sampling form the finger tip
10) Individuals who have been considered to exclude the participants based on a researcher
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tatsuro |
| Middle name | |
| Last name | Amano |
Organization
Niigata University
Division name
Faculty of Education
Zip code
9502181
Address
8050, Igarashi 2, Nishi-ku, Niigata, Niigata
TEL
025-262-7161
amano@ed.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuro |
| Middle name | |
| Last name | Amano |
Organization
Niigata University
Division name
Faculty of Education
Zip code
9502181
Address
8050, Igarashi 2, Nishi-ku, Niigata, Niigata
TEL
025-262-7161
Homepage URL
amano@ed.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Bourbon 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 ethical committee of Niigata University
Address
8050, Igarashi 2, Nishi-ku, Niigata, Niigata
Tel
025-227-2625
ethics@adm.niigata-u.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
| 2018 | Year | 07 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
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 | 06 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2018 | Year | 12 | 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
| 2018 | Year | 07 | Month | 20 | Day |
Last modified on
| 2019 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038159
