UMIN-CTR Clinical Trial

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
Email	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
Email	amano@ed.niigata-u.ac.jp

Sponsor
Institute	Niigata University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038159