UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049195 |
|---|---|
| Receipt number | R000056034 |
| Scientific Title | Effects of weight loss program with different rate and duration before competition on stress responses and athletic performance |
| Date of disclosure of the study information | 2022/10/13 |
| Last modified on | 2024/04/13 18:47:55 |
* 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 weight loss program with different rate and duration before competition on stress responses and athletic performance
Acronym
Effects of weight loss program with different rate and duration before competition on stress responses and athletic performance
Scientific Title
Effects of weight loss program with different rate and duration before competition on stress responses and athletic performance
Scientific Title:Acronym
Effects of weight loss program with different rate and duration before competition on stress responses and athletic performance
Region
| Japan |
Condition
Condition
Normal
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of weight loss program with different rate and duration before competition on stress responses and athletic performance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary alpha-amylase
POMS2(Profile of Mood States Second Edition Adults Forms)
Key secondary outcomes
Body weight
Body composition
Energy intake
Athletic performances
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 15 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Athletes who have given written informed consent to participate in this study.
Key exclusion criteria
Those who cannot obtain written informed consent for participation in this study.
Those who cannot obtain parental consent for participation in this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Michiyo |
| Middle name | |
| Last name | Kimura |
Organization
Takasaki University of Health and Welfare
Division name
Graduate School of Health and Welfare
Zip code
370-0033
Address
37-1 Nakaorui, Takasaki city, Gunma
TEL
027-352-1290
kimura@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Michiyo |
| Middle name | |
| Last name | Kimura |
Organization
Takasaki University of Health and Welfare
Division name
Faculty of Health and Welfare
Zip code
370-0033
Address
37-1 Nakaorui, Takasaki city, Gunma
TEL
027-352-1290
Homepage URL
kimura@takasaki-u.ac.jp
Sponsor or person
Institute
Takasaki University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Takasaki University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Committee at Takasaki University of Health and Welfare
Address
37-1 Nakaorui, Takasaki city, Gunma
Tel
027-352-1290
mune@takasaki-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
高崎健康福祉大学
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 13 | 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
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective cohort study
Management information
Registered date
| 2022 | Year | 10 | Month | 12 | Day |
Last modified on
| 2024 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056034
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
