UMIN-CTR Clinical Trial

Basic information
Public title	Effects of food ingredients on knee joint symptoms in healthy volunteers with knee joint symptoms.
Acronym	Effects of food ingredients on knee joint symptoms.
Scientific Title	Effects of food ingredients on knee joint symptoms in healthy volunteers with knee joint symptoms.
Scientific Title:Acronym	Effects of food ingredients on knee joint symptoms.
Region	Japan

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

Objectives
Narrative objectives1	This study aims to evaluate the effects of ingestion of food ingredients on knee joint subjective symptoms.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	JKOM, JOA
Key secondary outcomes	Knee joint subjective symptoms (VAS) Blood test (CTx-II, C2C, PIIANP)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Ingestion of food ingredients-1 for 12 consecutive weeks.
Interventions/Control_2	Ingestion of food ingredients-2 for 12 consecutive weeks.
Interventions/Control_3	Ingestion of food ingredients-3 for 12 consecutive weeks.
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. Subjects who are adult male and female with subjective symptoms of knee joint pain. 2. Subjects with relatively high degree of knee pain in subjective symptoms. 3. Subjects who have agreed to participate in this study.
Key exclusion criteria	1. Subjects with a history of treatment of malignant tumor, heart failure, myocardial infarction. 2. Subjects receiving treatment for the following chronic diseases, atrial fibrillation, arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, knee joint disease, other chronic diseases. 3. Subjects who routinely use medicines (including herbal medicine). 4. Subjects who are taking action to improve knee joint pain (including going to the hospital and treatment), and using medicines and health foods. 5. Subjects with allergies (medicine / test food related food). 6. Subjects who are planning to become pregnant or lactating. 7. Subjects who are judged as unsuitable for the study by doctor for other reasons.
Target sample size	48

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Yamatsu
Organization	Pharma Foods International Co., Ltd.
Division name	Research and Development Department
Zip code	615-8245
Address	1-49 Goryo-Ohara, Nishikyo-ku, Kyoto
TEL	075-394-8605
Email	a-yamatsu@pharmafoods.co.jp

Public contact
Name of contact person	1st name Maya Middle name Last name Sakashita
Organization	Pharma Foods International Co., Ltd.
Division name	Research and Development Department
Zip code	615-8245
Address	1-49 Goryo-Ohara, Nishikyo-ku, Kyoto
TEL	075-394-8605
Homepage URL
Email	m-sakashita@pharmafoods.co.jp

Sponsor
Institute	Pharma Foods International Co., Ltd.
Institute
Department

Funding Source
Organization	Pharma Foods International Co., Ltd.
Organization
Division
Category of Funding Organization	Self funding
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	2019 Year 10 Month 14 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	48
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	No longer recruiting
Date of protocol fixation	2019 Year 06 Month 27 Day
Date of IRB	2019 Year 07 Month 17 Day
Anticipated trial start date	2020 Year 01 Month 15 Day
Last follow-up date	2020 Year 04 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	2019 Year 10 Month 14 Day
Last modified on	2020 Year 04 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043645