UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042644 |
|---|---|
| Receipt number | R000048661 |
| Scientific Title | Comparisons of different carbohydrate ingestions on exercise performance and thermoregulation |
| Date of disclosure of the study information | 2020/12/03 |
| Last modified on | 2021/12/16 22:21:02 |
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Basic information
Public title
Comparisons of different carbohydrate ingestions on exercise performance and thermoregulation
Acronym
Endurance exercise and carbohydrate ingestion
Scientific Title
Comparisons of different carbohydrate ingestions on exercise performance and thermoregulation
Scientific Title:Acronym
Endurance exercise and carbohydrate 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 carbohydrates ingestion on fluid and thermoregulatory responses during exercise and at rest.
Basic objectives2
Others
Basic objectives -Others
We also evaluate the influence of protein, electrolytes, and glycerol ingestion with carbohydrate on fluid and thermoregulatory responses during exercise and at rest.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma volume, blood glucose, urine volume, beverage hydration index, exercise performance (exercise test only)
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
9
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Sucrose ingestion (6.5% concentration, 1L)
Interventions/Control_2
Isomaltulose ingestion (6.5% concentration, 1L)
Interventions/Control_3
70g Isomaltulose + 5g NaCl + 70g glycerol ingestion (1L)
Interventions/Control_4
70g sucrose + 5g NaCl + 70g glycerol ingestion (1L)
Interventions/Control_5
1L of water ingestion
Interventions/Control_6
6% sucrose
Interventions/Control_7
4%sucrose + 2% protein
Interventions/Control_8
6% isomaltulose
Interventions/Control_9
4%isomaltulose + 2% protein
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Aged over 20 yrs
2) Habitually trained individuals
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
20
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
950-2181
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
950-2181
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
Niigata University ethical committee
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
| 2020 | Year | 12 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 03 | Day |
Last modified on
| 2021 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048661
