UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035056
Receipt number 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 2020/06/01 09:19:56

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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 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 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

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

Value
https://center6.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