UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047825 |
|---|---|
| Receipt number | R000049478 |
| Scientific Title | Effects of body water retention with carbohydrate loading on physiological response and exercise performance in hot and thermoneutral environment |
| Date of disclosure of the study information | 2022/05/23 |
| Last modified on | 2022/11/24 15:52:28 |
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Basic information
Public title
Effects of carbohydrate loading on exercise performance in a hot environment
Acronym
Effectiveness of carbohydrate loading in a hot environment
Scientific Title
Effects of body water retention with carbohydrate loading on physiological response and exercise performance in hot and thermoneutral environment
Scientific Title:Acronym
Effects of carbohydrate loading on exercise performance in hot and thermoneutral environment
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects of body water retention with carbohydrate loading on rectal temperature in hot and thermoneutral environment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
rectal temperature
Key secondary outcomes
skin temperature, body composition, dietary intake, thermal sensation, rating of perceived exertion, sweat rate, urine osmotic pressure, complete blood count, serum sodium, serum potassium, blood lactate concentration, oxygen consumption, ventilation threshold, respiratory exchange ratio, heart rate, exercise performance
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
3 days consumption of additional carbohydrate (6 g/kg body weight/day)
Interventions/Control_2
5 days consumption of additional creatine (20 g/day)
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Subjects who are judged as healthy by self-reported health questionnaire.
2. Subjects who have exercise habits more than 3-month.
3. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Key exclusion criteria
1. Subjects who have stopped exercising by a doctor.
2. Subjects who regularly take drugs, foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshinari |
| Middle name | |
| Last name | Uehara |
Organization
Fukuoka University
Division name
Faculty of Sports Science
Zip code
814-0180
Address
8-19-1 Nanakuma, Jonan-ku, Fukuoka, Japan
TEL
092-871-6631
ueharay@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Shiose |
Organization
University of Miyazaki
Division name
Faculty of Education
Zip code
889-2192
Address
1-1 Gakuen Kibanadai-nishi, Miyazaki, Japan
TEL
0985-75-7558
Homepage URL
kshiose@cc.miyazaki-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Faculty of Education, University of Miyazaki
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Ethics Committee of Fukuoka University
Address
Nanakuma 7-45-1. Jonan-ku, Fukuoka, Japan
Tel
092-801-1011
fumed-ethics@fukuoka-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
| 2022 | Year | 05 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 22 | Day |
Last modified on
| 2022 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049478
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
