UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045395 |
|---|---|
| Receipt number | R000051836 |
| Scientific Title | An empirical study of personalized protein recommendation algorithm |
| Date of disclosure of the study information | 2021/09/07 |
| Last modified on | 2022/04/07 16:05:59 |
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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
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
IRB_dis@dena.com
Sponsor or person
Institute
DeNA Life Science, Inc
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
The ethical committee of DeNA Life Science, Inc
Address
2-24-12, Shibuya, Shibuya-ku, Tokyo
Tel
0120-08-4946
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051836
