UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044445 |
|---|---|
| Receipt number | R000050430 |
| Scientific Title | Effects of amino acids-enriched food on Achilles tendon discomfort in healthy adults who habitually exercise |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2024/06/26 13:48:30 |
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Basic information
Public title
Effects of amino acids-enriched food on Achilles tendon discomfort in healthy adults who habitually exercise
Acronym
Effects of amino acids-enriched food on Achilles tendon discomfort
Scientific Title
Effects of amino acids-enriched food on Achilles tendon discomfort in healthy adults who habitually exercise
Scientific Title:Acronym
Effects of amino acids-enriched food on Achilles tendon discomfort
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 Achilles tendon discomfort
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analogue Scale
Key secondary outcomes
TNF-alpha
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
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Amino acids(4 g, once a day, for 2 weeks)
Interventions/Control_2
Placebo(4 g, once a day, for 2 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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Male and female aged 20 or higher and less than 60 years old.
2. Individuals who have discomfort in Achilles tendon and do not show blood vessel infiltration into Achilles tendon evaluated by an ultrasonography.
3. Individuals who have discomfort in Achilles tendon during exercise or the day after exercise
4. Individuals who exercise more than 2 times a week.
5. Individuals who can make self-judgment and voluntarily provides written informed consent.
Key exclusion criteria
1. Individuals who had a surgery or local injections within one year.
2. Individuals who are in need of a treatment for Achilles tendon, judged by the principal investigator.
3. Individuals who have received a surgery for Achilles tendon in the past.
4. Individuals who are under medications which may affect Achilles tendon such as poultice, ointment or painkiller.
5. Individuals who have severe chronic diseases (hepatic, cardiovascular, respiratory, endocrine, and metabolic disorders)
6. Individuals who are impossible to stop taking supplements or functional foods which may affect Achilles tendon during this study.
7. Indivicuals who take amino acid -related medicines such as LIVACT, AminolebanEN and Hepan ED.
8. Individuals who regularly take amino acid/protein supplements.
9. Individuals who have amino acid metabolism disorders.
10. Individuals who are pregnant, lactating or have these plans.
11. Individuals who received more than 200 mL of blood collection within 12 weeks from the screening test.
12. Individuals who have participated in a study using other food intake or medicines, and cosmetics within one month retrospectively from the time of obtaining consent, or who are participating in other examinations during this study participation.
13. Individuals who are judged as unsuitable for the study by the investigator for the other reasons.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Sekiguchi |
Organization
Urayasu Sekiguchi Clinic
Division name
Director
Zip code
279-0004
Address
5-17-27, Urayasu-shi, Nekozane, Chiba-ken, Japan
TEL
047-306-3557
scfira@royal.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Sales Department
Zip code
105-0023
Address
Shibaura OMODAKA Bldg. 7F, 1-9-7 Shibaura, Minato-ku, Tokyo,Japan
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO corporation
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
Ethical Committee of Nihonbashi Cardiology Clinic
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel
03-5641-4133
niho-jimucho@well-sleep.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | 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
| 2021 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 05 | Day |
Last modified on
| 2024 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050430
