UMIN-CTR Clinical Trial

Basic information
Public title	An empirical study of personalized protein recommendation algorithm
Acronym	An empirical study of personalized protein recommendation algorithm
Scientific Title	An empirical study of personalized protein recommendation algorithm
Scientific Title:Acronym	An empirical study of personalized protein recommendation algorithm
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Main objective is to exploratory evaluate the effects on behavior and awareness with protein intake persistence, body condition or composition of participants under the personalized protein intake algorithm.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	1)Body weight, body composition (body fat mass and body muscle mass) 2)Amount and type of protein intake and exercise (type, intensity, duration)
Key secondary outcomes	3)Physical condition, mood, awareness and behavior toward protein intake, exercise, diet, and body shape 4)Nutritional intake status

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Food
Interventions/Control_1	Take food twice a day for 12 weeks.
Interventions/Control_2
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	50 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Healthy volunteers (female/male), 30-50 age (time of informed consent) (2) Subjects obtained consent of participate DLS conducted research with data and samples through "MYCODE" DTC genetic test service. (3) Subjects obtained written consent intend to participate actively with well understanding with this study. (4) Subjects who can visit to the designated study date and participate in the study (5) Those who exercise at least once a week on a daily basis and can continue to exercise at least once a week during the test period. (6) Those who can cooperate with the dietary survey using the dietary survey application using a smartphone (record a total of 12 days within the test period). (7) Approximately 5-6 participants will be selected for each of the following categories from a) to f). a) Those who currently intake protein habitually, are conscious of the need to increase body muscle mass, and have a habit of resistance training at a gym at least twice a week. b) Those other than a) who currently intake protein on a habitual basis and have a desire to increase muscle mass. c) Those who currently intake protein habitually and want to reduce body fat mass and weight. d) Those who do not currently intake protein, but are interested in consuming protein and wish to increase their body muscle mass. e) Those who do not currently consume protein, but are interested in consuming protein and want to reduce body fat and weight. f) Those who do not currently consume protein and are not interested in consuming protein.
Key exclusion criteria	(1) Those who have withdrawn their consent to participate in this study for their own reasons. (2) Those who have a chronic medical condition that requires medication, those who have a history of serious illness that requires medication, or those who use pacemakers or other implantable medical electronic devices. (3) Those who may have allergic symptoms to the test food, or those who may have serious allergic symptoms to other foods or medicines. (4) Those who are pregnant, breastfeeding or may become pregnant. (5) Those who have participated in other clinical trials or monitoring studies in the last month, or those who plan to participate in other clinical trials or monitoring studies during this study period.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Yoneyama Middle name Last name Hiroshi
Organization	DeNA Life Science, Inc
Division name	Member of the Board President
Zip code	150-6140
Address	2-24-12, Shibuya, Shibuya-ku, Tokyo
TEL	0120-08-4946
Email	IRB_dis@dena.com

Public contact
Name of contact person	1st name Hitomi Middle name Last name Akio
Organization	DeNA Life Science, Inc
Division name	MYCODE service Dept
Zip code	150-6140
Address	2-24-12, Shibuya, Shibuya-ku, Tokyo
TEL	0120-08-4946
Homepage URL
Email	IRB_dis@dena.com

Sponsor
Institute	DeNA Life Science, Inc
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	The ethical committee of DeNA Life Science, Inc
Address	2-24-12, Shibuya, Shibuya-ku, Tokyo
Tel	0120-08-4946
Email	IRB_dis@dena.com

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	2021 Year 09 Month 07 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	2021 Year 07 Month 30 Day
Date of IRB	2021 Year 08 Month 10 Day
Anticipated trial start date	2021 Year 09 Month 29 Day
Last follow-up date	2022 Year 01 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 09 Month 06 Day
Last modified on	2022 Year 04 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051836