UMIN-CTR Clinical Trial

Basic information
Public title	A study to evaluate the effect of food ingredient in healthy adult on the knee discomfort -Placebo-controlled, randomized, double-blind, parallel-group comparative method
Acronym	A study to evaluate the effect of food ingredient in healthy adult on the knee discomfort -Placebo-controlled, randomized, double-blind, parallel-group comparative method
Scientific Title	A study to evaluate the effect of food ingredient in healthy adult on the knee discomfort -Placebo-controlled, randomized, double-blind, parallel-group comparative method
Scientific Title:Acronym	A study to evaluate the effect of food ingredient in healthy adult on the knee discomfort -Placebo-controlled, randomized, double-blind, parallel-group comparative method
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effect of test food intake for 12 consecutive weeks on knee discomfort using placebo as a control
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Knee function questionnaire
Key secondary outcomes	Blood test

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	Ingestion of test food (research food)
Interventions/Control_2	Ingestion of 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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Japanese adult males and females between 20 and 70 years of age (2) Subjects who have been judged to be healthy by a physician (3) Of the above subjects, those who have experienced discomfort in the knee from the past year to the present (at the time of screening)
Key exclusion criteria	(1)Subjects who are taking medication or visiting a hospital (2)Subjects with a history of serious diseases (3) Subjects who have participated in other clinical trials within the past month (4) Subjects who are binge drinkers or have an irregular diet (5) Subjects who are judged as inappropriate by the physician in charge of the study (6) Subjects with food allergies or drug allergies (7) Subjects who have been diagnosed as severe (Grade II or higher) by the Kellgren-Laurence classification
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Ryosuke Middle name Last name Mastuoka
Organization	Kewpie Corporation
Division name	R&D Division
Zip code	1820002
Address	2-5-7, Sengawa-cho, Chofu-shi, Tokyo
TEL	03-5384-7759
Email	ryosuke_matsuoka@kewpie.co.jp

Public contact
Name of contact person	1st name Tomomi Middle name Last name Tanaka
Organization	Kewpie Corporation
Division name	R&D Division
Zip code	1820002
Address	2-5-7, Sengawa-cho, Chofu-shi, Tokyo
TEL	03-5384-7759
Homepage URL
Email	tomomi_tanaka@kewpie.co.jp

Sponsor
Institute	Hokkaido University of Education Kewpie Corporation
Institute
Department

Funding Source
Organization	Kewpie Corporation
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	Hokkaido University of Education Ethics Review Committee
Address	2-34-1, Midorigaoka, Iwamisawa, Hokkaido
Tel	0126-32-0214
Email	iwa-somu@j.hokkyodai.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

Other administrative information
Date of disclosure of the study information	2021 Year 11 Month 04 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	2021 Year 03 Month 26 Day
Date of IRB	2021 Year 03 Month 26 Day
Anticipated trial start date	2021 Year 12 Month 11 Day
Last follow-up date	2022 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 11 Month 04 Day
Last modified on	2021 Year 11 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052381