UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034158 |
|---|---|
| Receipt number | R000038943 |
| Scientific Title | The examination of more effective diet strategy on increasing fat free mass. |
| Date of disclosure of the study information | 2018/09/15 |
| Last modified on | 2020/03/12 12:50:18 |
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Basic information
Public title
The examination of more effective diet strategy on increasing fat free mass.
Acronym
The examination of more effective diet strategy on increasing fat free mass.
Scientific Title
The examination of more effective diet strategy on increasing fat free mass.
Scientific Title:Acronym
The examination of more effective diet strategy on increasing fat free mass.
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of adding different amounts of energy intake to energy requirements on body composition
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body composition from a 4-component model(fat, water, mineral, and protein).
Key secondary outcomes
Body weight, Basal metabolic rate, energy expenditure, Blood parameters regarding protein, fat, carbohydrate metabolism, energy intake, muscle power
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Protein intake for 6 weeks.
Energy intake of protein was energy requirement x 0.1.
Interventions/Control_2
Protein intake and carbohydrate for 6 weeks. Energy intake of protein was energy requirement x 0.1 and of carbohydrate was energy requirement x 0.3.
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
| 45 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Individuals who understand the purpose and contents of the study, have ability to provide written consent, and give the written informed consent form
2) Healthy men whose age 20 to 45 years old
Key exclusion criteria
1) Who have severe or progressive disorder
2) Who have history of digestive surgery
3) Who have medical history in kidney
4) Constant use of medicine
5) Who drink a lot of alcohol
6) Whose eating habits are extremely irregular
7) Who participate or are willing to participate clinical trials of other food products, drugs, or beauty products.
8) Who are allergic to milk, soy, apples, mangoes, grapes or blackcurrants
9) Constant use of supplements ex. Protein and amino acids
10) Who are judged as unsuitable for the study by the principal investigator for other reasons
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kentaro Kawanaka |
Organization
Fukuoka University
Division name
Faculty of Sports and Health Science
Zip code
Address
8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
TEL
092-871-6631(6720)
kawanaka@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shihoko Nakashima |
Organization
Fukuoka University
Division name
Faculty of Sports and Health Science
Zip code
Address
8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
TEL
092-871-6631
Homepage URL
http://www.fuipa.spo.fukuoka-u.ac.jp/
shihoko@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
福岡大学スポーツ科学部（福岡）
基盤研究機関身体活動研究所
Fukuoka University in Faculty of Sports and Health Science
Central Research Institute for Physical Activity
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 15 | 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
| 2018 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 05 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 09 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 09 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 15 | Day |
Last modified on
| 2020 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038943
| Research Plan | |
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| 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 |
