UMIN-CTR Clinical Trial

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
Email	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
Email	ykawa@waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041301