UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041805 |
|---|---|
| Receipt number | R000047727 |
| Scientific Title | Effects of supplementary intake of milk protein and medium-chain triglyceride in combination with exercise training on body composition in female university students |
| Date of disclosure of the study information | 2020/09/28 |
| Last modified on | 2022/02/26 09:41:34 |
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Basic information
Public title
Effects of supplementary intake of milk protein and medium-chain
triglyceride in combination with exercise training on body composition
in female university students
Acronym
Effects of supplementary intake of milk protein and medium-chain
triglyceride in combination with exercise training on body composition
in female university students
Scientific Title
Effects of supplementary intake of milk protein and medium-chain
triglyceride in combination with exercise training on body composition
in female university students
Scientific Title:Acronym
Effects of supplementary intake of milk protein and medium-chain
triglyceride in combination with exercise training on body composition
in female university students
Region
| Japan |
Condition
Condition
Nomal
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of supplementary intake of milk protein and medium-chain
triglyceride in combination with exercise training on body composition
in female university students
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body composition
Key secondary outcomes
Quality of life
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food | Maneuver |
Interventions/Control_1
Supplementary intake of placebo with exercise training for 12 weeks
Interventions/Control_2
Supplementary intake of milk protein and long-chain triglyceride in combination with exercise training for 12 weeks
Interventions/Control_3
Supplementary intake of milk protein and medium-chain triglyceride in combination with exercise training for 12 weeks
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
| 24 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy female university students who have given written informed consent
Key exclusion criteria
Subjects
1)who have heart disease and/or respiratory disease and/or injury
2)who having take medicine
3)with food allergies (soybean, milk)
4)who having a smoking habit
5)who are judged as ineligible by the doctor for other reasons
Target sample size
45
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
Faculty 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
3700033
Address
37-1 Nakaorui,Takasaki city,Gunma
TEL
0273521290
Homepage URL
kimura@takasaki-u.ac.jp
Sponsor or person
Institute
Takasaki University of Health and Welfare
Faculty of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Meiji Co.,Ltd
R&D Division
Food Development Laboratories
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takasaki University of Health and Welfare
Address
37-1 Nakaorui,Takasaki city,Gunma
Tel
0273521290
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 28 | 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
33
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
| 2020 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2021 | 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
| 2020 | Year | 09 | Month | 15 | Day |
Last modified on
| 2022 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047727
