UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000035751 |
|---|---|
| Receipt number | R000040720 |
| Scientific Title | Functional evaluation of amino acids-enriched food for healthy adults with discomfort in tendon |
| Date of disclosure of the study information | 2022/09/30 |
| Last modified on | 2021/06/05 22:52:48 |
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Basic information
Public title
Functional evaluation of amino acids-enriched food for healthy adults with discomfort in tendon
Acronym
Evaluation of amino acids-enriched food on discomfort in tendon in healthy adults
Scientific Title
Functional evaluation of amino acids-enriched food for healthy adults with discomfort in tendon
Scientific Title:Acronym
Evaluation of amino acids-enriched food on discomfort in tendon in healthy adults
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effects of the test food on discomfort in tendon
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analogue Scale, VISA, Argometer
Key secondary outcomes
Blood parameter
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
amino acids
Interventions/Control_2
Placebo
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Between 20 and 30 years old men and women who belong to University of Tsukuba
2) Subjects who feel exercise-induced discomfort in knee and Achilles.
3) Subjects who provided written informed consent.
Key exclusion criteria
1) Individuals who require a medication and an operation
2) Individuals who received more than 200 mL of blood collection within 12 weeks
3) Individuals who have surgical and medical diseases which may interfere with the results of this study
4) Individuals whose discomfort disappeared before the intervention
5) Individuals who are assed to be inappropriate by the principal investigator due to other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Naomi |
| Middle name | |
| Last name | Omi |
Organization
University of Tsukuba
Division name
Faculty of Health and Sport Sciences
Zip code
305-8574
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8574, Japan
TEL
029-853-6319
omi.naomi.gn@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Kanamori |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8574
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8574, Japan
TEL
090-4530-0062
Homepage URL
kanamori@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
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
University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8574, Japan
Tel
029-853-6319
omi.naomi.gn@u.tsukuba.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
筑波大学 体育総合実験棟（SPEC）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 30 | 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
27
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
| 2019 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 02 | Day |
Last modified on
| 2021 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040720
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
