UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053421 |
|---|---|
| Receipt number | R000060718 |
| Scientific Title | Dietary Record Survey of Healthy Adult Men and Women |
| Date of disclosure of the study information | 2024/01/24 |
| Last modified on | 2024/01/24 09:17:03 |
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Basic information
Public title
Dietary Record Survey of Healthy Adult Men and Women
Acronym
Dietary Record Survey of Healthy Adult Men and Women
Scientific Title
Dietary Record Survey of Healthy Adult Men and Women
Scientific Title:Acronym
Dietary Record Survey of Healthy Adult Men and Women
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Conduct a detailed diet record survey of healthy adult men and women using the meal recording method to obtain basic data for the development of solutions and nutritional evaluation methods.
Basic objectives2
Others
Basic objectives -Others
Others
Trial characteristics_1
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
Protein intake
Intake of each Amino acid
The appearance frequency and digestibility of each protein food
Frequency of dish appearance Combination of dishes
Nutritional balance of dishes and meals
Key secondary outcomes
Diet/health awareness
Lifestyle
Awareness about protein
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Men and women between the ages of 20 and 79.
(2) Subjects who do not have a chronic disease that requires regular hospital visits and drug treatment.
(3) Subjects who do not follow any special dietary restrictions for themselves or their families under the direction of a doctor.
(4) Subjects who are able to record their meals for one week (record in a diary, take photos of meals)
(5) Subjects who do not miss any of the three meals a day and cooks at least 14 meals a week at home.
(6) Subjects who have received a sufficient explanation about their participation in the research, have fully understood it, and have given their free written consent.
Key exclusion criteria
(1) Those who have an irregular rhythm of life (shift work, late-night work, etc.)
(2) Those who plan to make major changes to their lifestyle, such as long-term travel, during the exam period.
(3) Other persons deemed inappropriate by the research director
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Okabe |
Organization
Ajinomoto Co., Inc.
Division name
Institute of Food Science and Technologies
Zip code
2108681
Address
1-1,Suzuki-cho,Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
07040179653
yuki.okabe.z4s@asv.ajinomoto.com
Public contact
Name of contact person
| 1st name | Lili |
| Middle name | |
| Last name | Cao |
Organization
Ajinomoto Co., Inc.
Division name
Institute of Food Science and Technologies
Zip code
2108681
Address
1-1,Suzuki-cho,Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
08077561189
Homepage URL
lili.cao.yr5@asv.ajinomoto.com
Sponsor or person
Institute
Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Co., Inc.
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
AJINOMOTO CO., INC. Committee for the Examination of Trials Involving Humans
Address
15-1, Kyobashi 1-chome, Chuo-ku, Tokyo, Japan
Tel
03-5250-8111 +81-3-5250-8111
ajinomoto_irb@ajinomoto.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
| 2024 | Year | 01 | Month | 24 | 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
| 2023 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 01 | Month | 24 | Day |
Last modified on
| 2024 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060718
