UMIN-CTR Clinical Trial

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