UMIN-CTR Clinical Trial

Basic information
Public title	Functional evaluation of amino acid and fatty acid-containing food for healthy adults with discomfort of the waist and knees
Acronym	Evaluationof amino acid and fatty acid-containing food on discomfort in waist and knees
Scientific Title	Functional evaluation of amino acid and fatty acid-containing food for healthy adults with discomfort of the waist and knees
Scientific Title:Acronym	Evaluationof amino acid and fatty acid-containing food on discomfort in waist and knees
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Functional evaluation of improvement effects for test food on discomfort in waist and/or knee
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	JLEQ JOA score JKOM
Key secondary outcomes	BPI VAS about daily life or condition of sholder etc. EQ-5D

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 acid and fatty acid-containing food
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1.20 years of age or older men and women 2.Subjects with a sense of discomfort in the low back and knee 3.Subjects who were judged not to have only nociceptive pain by PainDETECT 4.Subjects who judged to be healthy by medical doctor 5.Subjects who provided written informed consent.
Key exclusion criteria	1.Subjects who constantly take medication that affects pain 2.Subjects who are clear of the causes of pain, such as hernia, spinal canal stenosis, knee osteoarthropathy 3.Subjects who received the surgery in the past for related the study 4.Subjects judged to have psychiatric problems with BS-POP 5.Subjects who are taking health food or supplements which may influence the outcome of the study 6.Subjects who take amino acid preparations 7.Subjects who regularly use amino acids or protein supplements 8.Subjects who regularly use supplements based on functional fatty acids 9.Subjects who are pregnant or lactating and have these plans 10.Subjects who are allergic to fish and soy food 11.Subjects with amino acid metabolism disorder 12.Subject who have participated in the test of using other food intake or medicines, and cosmetics within one month retrospectively from the time of obtaining consent, or participating in other examinations during this study participation 13.Subjects who are judged as unsuitable for the stury by the investigator for the other reason
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Yasuo Middle name Last name Kobuna
Organization	Kobuna orthopedic surgery
Division name	Medical Office
Zip code	371-0813
Address	311-2, Gokanmachi, Maebashi, Gunma
TEL	027-261-7600
Email	info@kobunaseikei.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
TEL	03-3452-7733
Homepage URL
Email	yoshi@kso.co.jp

Sponsor
Institute	KSO Corporation
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	Ethics Committee of Ajinomoto Co., Ltd
Address	15-1, Kyobashi 1-chome, Chuo-ku, Tokyo, Japan
Tel	03-5250-8111
Email	ajinomoto_irb@ajinomoto.com

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	2018 Year 11 Month 28 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	2018 Year 09 Month 21 Day
Date of IRB	2018 Year 11 Month 25 Day
Anticipated trial start date	2018 Year 12 Month 03 Day
Last follow-up date	2019 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 11 Month 28 Day
Last modified on	2020 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039965