UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000036259 |
|---|---|
| Receipt number | R000041301 |
| Scientific Title | Effect of non-essential amino acids-enriched food on discomfort, exercise-induced morphological and functional changes in the Achilles tendon |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2020/06/08 09:30:51 |
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Basic information
Public title
Effect of non-essential amino acids-enriched food on discomfort, exercise-induced morphological and functional changes in the Achilles tendon
Acronym
Effect of amino acids-enriched food on the Achilles tendon
Scientific Title
Effect of non-essential amino acids-enriched food on discomfort, exercise-induced morphological and functional changes in the Achilles tendon
Scientific Title:Acronym
Effect of amino acids-enriched food on the Achilles tendon
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of amino acids-enriched food on tendon.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ultrasonograhy
Elastography
Visual Analogue Scale
Key secondary outcomes
Changes in 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
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
1)Individuals who feel exercise-induced discomfort in the Achilles tendon.
2) Individuals who provided written informed consent.
3) Individuals who can exercise
Key exclusion criteria
1) Individuals who had a surgery or local injections within 1 year
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 who are assessed to be inappropriate by the principal investigator due to other reasons
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Kawakami |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
162-0041
Address
2-579-15,Mikajima, Tokorozawa, Saitama 359-1192, Japan
TEL
04-2947-6766
ykawa@waseda.jp
Public contact
Name of contact person
| 1st name | Yasuo |
| Middle name | |
| Last name | Kawakami |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
162-0041
Address
2-579-15,Mikajima, Tokorozawa, Saitama 359-1192, Japan
TEL
04-2947-6766
Homepage URL
ykawa@waseda.jp
Sponsor or person
Institute
Waseda University
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
Waseda university
Address
2-579-15,Mikajima, Tokorozawa, Saitama 359-1192, Japan
Tel
03-5272-1639
rinri@list.waseda.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
早稲田大学 所沢キャンパス（埼玉県）/Tokorozawa Campus of Waseda University（Saitama）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 01 | 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
| 2019 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 01 | 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 | 03 | Month | 19 | Day |
Last modified on
| 2020 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041301
| 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 |
