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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035056
Receipt No. R000039965
Scientific Title Functional evaluation of amino acid and fatty acid-containing food for healthy adults with discomfort of the waist and knees
Date of disclosure of the study information 2018/11/28
Last modified on 2019/05/30

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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
Middle name
Last name Yasuo Kobuna
Organization Kobuna orthopedic surgery
Division name Medical Office
Zip code
Address 311-2, Gokanmachi, Maebashi, Gunma
TEL 027-261-7600
Email info@kobunaseikei.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshika Komori
Organization KSO Corporation
Division name Sales Department
Zip code
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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2018 Year 09 Month 21 Day
Date of IRB
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
2019 Year 05 Month 30 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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