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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034158
Receipt No. 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 2018/09/15

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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)
Email 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/
Email shihoko@fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University
Institute
Department

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
Email

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 Preinitiation
Date of protocol fixation
2018 Year 08 Month 06 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 16 Day
Last follow-up date
2019 Year 05 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 15 Day
Last modified on
2018 Year 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038943

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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