UMIN-CTR Clinical Trial

Basic information
Public title	Effects of consumption of the test food in healthy Japanese with discomfort in the knee joint: a randomized, double-blind, placebo-controlled, parallel-group trial
Acronym	Effects of consumption of the test food in healthy Japanese with discomfort in the knee joint
Scientific Title	Effects of consumption of the test food in healthy Japanese with discomfort in the knee joint: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym	Effects of consumption of the test food in healthy Japanese with discomfort in the knee joint
Region	Japan

Condition
Condition	Healthy Japanese subjects
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effects on discomfort in the knee joint with the test food for 12 weeks in healthy Japanese adult subjects with discomfort in the knee joint
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The total score of Japanese Knee Osteoarthritis Measure (JKOM) * Compare the amount of change between screening (before consumption) and 12 weeks after consumption
Key secondary outcomes	1. JKOM Assess the total score of JKOM and the scores of visual analogue scale (VAS), pain and stiffness in knees, conditions in daily life, general activities, and health conditions 2. The Japanese Orthopaedic Association score for osteoarthritic knees (JOA) Assess JOA scores (the average in both legs, right leg, and left leg) 3. Subjective symptoms related to knee pains (VAS) 4. The 30-second chair stand test Assess the number of times of standing up from the chair for 30 seconds 5. The 10-meter walking test Assesse walking speed, the number of steps, stride length, and waking rate (the number of steps per time) 6. Blood test Assess high sensitivity C-reactive protein, cleavage of type II collagen, and myoglobin *1-6 Assess the items at screening (before consumption) and 4, 8, and 12 weeks after consumption and calculate the amount of change or rate of change. However, the total score of JKOM assesses only the value and rate of change at 12 weeks after consumption.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 12 weeks Test Material: Active tablets Dosage: Take 6 tablets with water or warm water after breakfast * If you forget to take the tablets, take tablets as soon as you remember within the day.
Interventions/Control_2	Duration: 12 weeks Test Material: Placebo tablets Dosage: Take 6 tablets with water or warm water after breakfast * If you forget to take the tablets, take tablets as soon as you remember within the day.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Healthy Japanese adult subjects 2. Subjects who are experiencing discomfort in the knee joint; however, subjects who are not diagnosed with any diseases by a physician 3. Subjects who are judged as eligible to participate in the study by the physician 4. Within the subjects who met the 1st to 3rd inclusion criteria, subjects who are judged in the Kellgren-Lawrence grade (KL grade) either 0 or 1 in X-ray at screening (before consumption) 5. Within the subjects who met the 4th inclusion criteria, subjects whose total scores of JKOM are relatively high at screening (before consumption)
Key exclusion criteria	1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 4. Subjects who are currently taking medications (including herbal medicines) and supplement * Particularly taking anticoagulants such as warfarin 5. Subjects who experience palpitations when they walk fast 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, breast-feeding, or planning to become pregnant 8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 9. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuo YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
Zip code
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	1st name Middle name Last name Naoko SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Zip code
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	DHC Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medical Corporation Seishinkai, Takara Clinic
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	医療法人社団盛心会 タカラクリニック (東京都) Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2018 Year 07 Month 19 Day

Related information
URL releasing protocol	Unpublished
Publication of results	Published

Result
URL related to results and publications	http://www.pieronline.jp/content/article/0386-3603/47120/2007
Number of participants that the trial has enrolled	66
Results	Kageyama M, Kobashi R, Tomobe H, Nakajima Y, Akiyoshi K, Ohmori R, Yamada A, Takahashi Y, Takara T. Effects of consumption of the test food containing glucosamine hydrochloride, methylsulfonylmethane, boswellia serrata extract, and olive extract in healthy Japanese subjects with knee joint discomfort: a randomized, double-blinded, placebo-controlled, parallel-group study. Jpn Pharmacol Ther. 2019; 47(12): 2007-2029
Results date posted	2021 Year 05 Month 27 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 01 Month 08 Day
Baseline Characteristics	Refer to the paper
Participant flow	Refer to the paper
Adverse events	Refer to the paper
Outcome measures	Refer to the paper
Plan to share IPD	Undecided
IPD sharing Plan description	To require consultation among related companies

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 07 Month 09 Day
Date of IRB	2018 Year 07 Month 09 Day
Anticipated trial start date	2018 Year 07 Month 20 Day
Last follow-up date	2019 Year 04 Month 20 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 07 Month 19 Day
Last modified on	2021 Year 05 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038134