UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037804 |
|---|---|
| Receipt number | R000042955 |
| Scientific Title | With the same intake of carbohydrates and proteins, Study on changes in body weight, body composition and maximum oxygen intake |
| Date of disclosure of the study information | 2020/12/10 |
| Last modified on | 2019/08/26 18:28:17 |
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Basic information
Public title
With the same intake of carbohydrates and proteins,
Study on changes in body weight, body composition and maximum oxygen intake
Acronym
With the same intake of carbohydrates and proteins,
Study on changes in body weight, body composition and maximum oxygen intake
Scientific Title
With the same intake of carbohydrates and proteins,
Study on changes in body weight, body composition and maximum oxygen intake
Scientific Title:Acronym
With the same intake of carbohydrates and proteins,
Study on changes in body weight, body composition and maximum oxygen intake
Region
| Japan |
Condition
Condition
metabolic syndrome
Locomotive Syndrome
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For those who are continuously exercising in the fitness gym, change the increase in carbohydrate intake and increase in protein intake for the same amount for the same period, and to determine the weight, body composition, and maximum oxygen intake We report on whether there is such a change.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum oxygen intake after 2 weeks of carbohydrate and protein loading
Key secondary outcomes
Body weight, body composition (muscle mass, body fat mass)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
15g carbohydrate daily for 2 weeks/ day of proteins for 2 weeks
Interventions/Control_2
15g protein daily for 2 weeks/ day of proteins for 2 weeks
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
People training at fitness club
Key exclusion criteria
None
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Isamu |
| Middle name | |
| Last name | Yokoyama |
Organization
Medical corporation association BiShinkai Kurosawa Hospital
Division name
Medical Fitness Valeopro
Zip code
370-1203
Address
187 Yanakacho, Takasaki City, Gunma Prefecture
TEL
027-350-1177
i_yokoyama@bishinkai.or.jp
Public contact
Name of contact person
| 1st name | Isamu |
| Middle name | |
| Last name | Yokoyama |
Organization
Medical corporation association BiShinkai Kurosawa Hospital
Division name
Medical Fitness Valeopro
Zip code
370-1203
Address
187 Yanakacho, Takasaki City, Gunma Prefecture
TEL
027-350-1177
Homepage URL
i_yokoyama@bishinkai.or.jp
Sponsor or person
Institute
Medical corporation association BiShinkai Kurosawa Hospital
Institute
Department
Personal name
Funding Source
Organization
Medical corporation association BiShinkai Kurosawa Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical corporation association BiShinkai Kurosawa Hospital
Address
187 Yanakacho, Takasaki City, Gunma Prefecture
Tel
027-350-1177
i_yokoyama@bishinkai.or.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 | 10 | 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
30
Results
The increased carbohydrate group showed an increase in maximum oxygen intake compared to the control group. In the increased carbohydrate group, the fat mass increased as compared to the control group and the increased protein group. Increased muscle mass was observed in the protein increase group compared to the control group and carbohydrate increase group.
Results date posted
| 2019 | Year | 08 | Month | 26 | Day |
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
| 2019 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | 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
| 2019 | Year | 08 | Month | 26 | Day |
Last modified on
| 2019 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042955
| 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 |
