UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054576 |
|---|---|
| Receipt number | R000062281 |
| Scientific Title | Effect of Ingestion of the Test Food A and Test Food B on Body Composition: An Exploratory Study |
| Date of disclosure of the study information | 2024/06/06 |
| Last modified on | 2025/06/05 09:09:13 |
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Basic information
Public title
Effect of Ingestion of the Test Food A and Test Food B on Body Composition: An Exploratory Study
Acronym
Effect of Ingestion of the Test Food A and Test Food B on Body Composition: An Exploratory Study
Scientific Title
Effect of Ingestion of the Test Food A and Test Food B on Body Composition: An Exploratory Study
Scientific Title:Acronym
Effect of Ingestion of the Test Food A and Test Food B on Body Composition: An Exploratory Study
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of 16 weeks ingestion of test food A and test food B on body composition.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body composition (body weight, body fat rate, body mass index, muscle mass, lean body mass, Skeletal Muscle Mass, SMI, ECW/TBW) at 16 weeks after ingestion.
Key secondary outcomes
Physical fitness test, Vital signs, Blood inflammatory marker, Blood anti-oxidant markers, Blood lipids, Blood glucose, Questionnaire assessed frailty.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Non-ingestion
Interventions/Control_2
Daily ingestion of test food A for 16 weeks.
Interventions/Control_3
Daily ingestion of test food A and test food B for 16 weeks.
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
| 60 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Subjects who fully understand significance, content and purpose of this study and who agree to participate in this study with a written informed consent.
2. Subjects who can write diary and questionnaire, visit an inspection facility and receive examinations in designated days.
Key exclusion criteria
1. Subjects who cannot perform activities of daily living on their own.
2. Subjects who cannot walk on their own and are restricted daily activities by physicians.
3. Subjects who are under physician's advice, treatment, and/or medication for quadriplegia, depression, dementia, neurological disease, amyotrophic lateral sclerosis.
4. Subjects with implantable electronic medical devices.
5. Subjects who are under treatment or have a history of serious diseases, or who affected with infectious diseases requiring reports to the authorities.
6. Subjects with major surgical history relevant to the digestive system.
7. Subjects who cannot ingestion test foods due to any reason, such as allergy.
8. Subjects who regularly take foods similar to test food A.
9. Subjects who regularly take foods similar to test food B.
10. Heavy smokers, alcohol addicts or subjects with disordered lifestyle.
11. Subjects who donated either 400 ml whole blood within 16 wks (women), 12 wks (men), 200 ml whole blood within 4 wks, or blood components within 2 wks, prior to this study.
12. Subjects who currently participate in other clinical trials or participated within the last 4 wks prior to the current study.
13. Subjects who are ineligible due to physician's judgment.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Naoyuki |
| Middle name | |
| Last name | HONMA |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
hisc-acad.res@s.do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | HONMA |
Organization
Hokkaido Information University
Division name
Health Information Science Center
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
Homepage URL
hisc-acad.res@s.do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
Meiji Holdings Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Hokkaido Information University
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
Tel
011-385-4411
soumu@do-johodai.ac.jp
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
北海道情報大学 保健センター（北海道）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 06 | 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
| 2024 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 05 | Day |
Last modified on
| 2025 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062281
