UMIN-CTR Clinical Trial

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
Email	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
Email	kanamori@md.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
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	University of Tsukuba
Address	1-1-1 Tennodai, Tsukuba, Ibaraki 305-8574, Japan
Tel	029-853-6319
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040720