UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056242 |
|---|---|
| Receipt number | R000064261 |
| Scientific Title | The relationship between sodium intake and change in body weight, body composition, and gastrointestinal symptoms during carbohydrate loading |
| Date of disclosure of the study information | 2024/12/31 |
| Last modified on | 2025/11/25 18:11:34 |
* 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
The relationship between sodium intake and change in body weight, body composition, and gastrointestinal symptoms during carbohydrate loading
Acronym
The relationship between sodium intake and change in body weight, body composition, and gastrointestinal symptoms during carbohydrate loading
Scientific Title
The relationship between sodium intake and change in body weight, body composition, and gastrointestinal symptoms during carbohydrate loading
Scientific Title:Acronym
The relationship between sodium intake and change in body weight, body composition, and gastrointestinal symptoms during carbohydrate loading
Region
| Japan |
Condition
Condition
To investigate the relationship between sodium intake and changes in body weight, body composition, and gastrointestinal symptoms during carbohydrate loading.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between sodium intake and changes in body weight, body composition, and gastrointestinal symptoms during carbohydrate loading.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in body weight before and after carbohydrate loading
Key secondary outcomes
1) Changes in body composition before and after carbohydrate loading
2) Gastrointestinal symptoms during carbohydrate loading
3) Physical activity levels before and during carbohydrate loading
4) Dietary intake before carbohydrate loading
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
3 days consumption of normal diet (carbohydrate; 5-6 g/kg body weight/day) with normal sodium intake.
Interventions/Control_2
3 days consumption of high carbohydrate diet (carbohydrate; 10-12 g/kg body weight/day) with normal sodium intake.
Interventions/Control_3
3 days consumption of high carbohydrate diet (carbohydrate; 10-12 g/kg body weight/day) with high sodium intake.
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Subjects who are judged as healthy by self-reported health questionnaire.
2. 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 are prohibited from exercising by a physician due to injury, etc.
2. Subjects currently participating in other trials during this research period or those intending to participate.
3. Subjects exhibiting symptoms of hypertension (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg).
4. Subjects who regularly use medications that may affect the trial.
5. Subjects deemed unsuitable as research subjects by the principal investigator for any other reason.
Target sample size
15
Research contact person
Name of lead principal investigator
| 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
TEL
0985-58-7558
kshiose@cc.miyazaki-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 Gakuenkibanadai-nishi, Miyazaki
TEL
0985-58-7558
Homepage URL
kshiose@cc.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Faculty of Education Research Ethics Committee in University of Miyazaki
Address
1-1 Gakuenkibanadai-nishi, Miyazaki
Tel
0985-58-7773
edusoumu@of.miyazaki-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2024-7-E-625
Org. issuing International ID_1
The Faculty of Education Research Ethics Committee in University of Miyazaki
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2030 | 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
| 2024 | Year | 11 | Month | 22 | Day |
Last modified on
| 2025 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064261
