UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053069 |
|---|---|
| Receipt number | R000060542 |
| Scientific Title | Exploratory study of a test food on performance and physical condition |
| Date of disclosure of the study information | 2024/07/31 |
| Last modified on | 2025/04/15 15:46:44 |
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Basic information
Public title
Exploratory study of a test food on performance and physical condition
Acronym
Exploratory study of a test food on performance and physical condition
Scientific Title
Exploratory study of a test food on performance and physical condition
Scientific Title:Acronym
Exploratory study of a test food on performance and physical condition
Region
| Japan |
Condition
Condition
N/A(healthy adults)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine effects of a test food for performance and physical condition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
performance measurement, questionnaire on physical condition
Key secondary outcomes
food intake frequency survey, body composition
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test foods, Continuous intake for 12 weeks
Interventions/Control_2
Non-intake, Continuous 12 weeks
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
1)Male college students exercising.
2)Japanese individuals aged 18-29 years.
3) Individuals who have not taken products containing ingredients of the test food.
4)Individuals whose eating habits will not change during the test period.
5)Individuals who are healthy without chronic physical illness.
6)Individuals whose written informed consent has been obtained.
7)Individulals who can visit an inspection facility and be inspected in designated days.
8)Individuals judged appropriate for the study by the principal.
Key exclusion criteria
1)Individuals with chronic illness.
2)Individuals whose medical history cannot be determined by the principal to have no effect on their participation in the study.
3)Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung and blood disease.
4)Individuals who contract or have a history of serious gastrointestinal disease.
5)Individuals with food allergy.
6)Individuals with alcoholism or a mental illness.
7)Individuals with serious anemia.
8)Individuals who are a smoker.
9)Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements containing ingredients of the test food.
10)Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements that have the function of improving specific areas of the body.
11)Individuals whose life style will change during the test period.
12)Individuals who will ingest health-promoting foods or supplements during the test period.
13)Individuals who have been diagnosed with inflammation or injury of specific areas of the body.
14)Individuals who have had surgery performed on a specific area of the body or who require surgery on a specific area of the body.
15)Individuals who were hospitalized and received treatment in the past 6 months.
16)Individuals who are currently participating in other clinical studies, or have not passed 3 month after participating in other clinical studies.
17)Individuals judged inappropriate for the study by the principal.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Toshihiro |
| Middle name | |
| Last name | Kawama |
Organization
Morinaga & Co., Ltd.
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama
TEL
045-571-6140
t-kawama-jb@morinaga.co.jp
Public contact
Name of contact person
| 1st name | Minori |
| Middle name | |
| Last name | Yamashita |
Organization
Morinaga & Co., Ltd.
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa
TEL
045-571-6140
Homepage URL
m-yamashita-bb@morinaga.co.jp
Sponsor or person
Institute
Morinaga & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
self-funding
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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Building 6F, 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
jimukyoku@mail.souken-r.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 | 07 | Month | 31 | 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
| 2023 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 12 | Day |
Last modified on
| 2025 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060542
