UMIN-CTR Clinical Trial

Basic information
Public title	Confirmation of correlation between improvement of knee pain and food-derived peptide in blood by dietary supplement intake
Acronym	Confirmation of correlation between improvement of knee pain and food-derived peptide in blood by dietary supplement intake
Scientific Title	Confirmation of correlation between improvement of knee pain and food-derived peptide in blood by dietary supplement intake
Scientific Title:Acronym	Confirmation of correlation between improvement of knee pain and food-derived peptide in blood by dietary supplement intake
Region	Japan

Condition
Condition	None
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of the dietary supplement of single and consecutive ingestion for 12 weeks in vivo dynamics of food-derived peptide in blood and on the knee pain
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Food-derived peptide in blood (plasma levels before and after ingestion, AUC, Cmax) Correlation between food-derived peptide in blood (AUC or Cmax) and JKOM
Key secondary outcomes	Food-derived peptide in urine JKOM Cartilage marker JOA Joint pain

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
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	A single and consecutive ingestion for 12 weeks of test food
Interventions/Control_2	A single and consecutive ingestion for 12 weeks of placebo food
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	40 years-old <=
Age-upper limit	74 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)Males and females at the ages of 40 to 74 (2)Subjects who have knee joint pain
Key exclusion criteria	(1)Subjects who are classified into 0 or IV grade on the basis of the KL classification (2)Subjects which knee join pain is weaker than pain in other joints (3)Subjects which JOA category I score are 30-points on both knee join (4)Subjects who are suspected gout attack with hyperuricemia (5)Subjects who have positive rheumatoid factors on the screening test or may have rheumatic pain (6)Subjects who have performed arthroplasty or need it (7)Subjects who regularly take health food containing bone, cartilage, joint from three month before the screening test to the end of the study (8)Subjects who regularly take medicine with some exceptions (9)Subjects who have been performed intra-articular hyaluronic acid or steroid drug injection within a year before the screening test (10)Subjects who get an intense exercise to make excessive load on the joints (11)Subjects who have a history of the disorder related to bone and joint such as fracture and sprain within a year before the screening test (12)Subjects who regularly use a cane or supporter (13)Subjects who periodically conduct actions that may affect the evaluation of effectiveness (14)Subjects who are biased in eating habits (15)Subjects who get a diagnosis of malignancy, are under treatment for cardiac disease, renal disease and thyroid dysfunction, and have a history of serious disorder such as hepatic disease (16)Subjects who drink alcohol in large quantities (17)Subjects who have at risk of developing food allergies (18)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (19)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (20)Subjects who have participated in other clinical study within a month before the screening test or who intend to participate in study period (21)Subjects who intend to become pregnant or lactating
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yukie Ito
Organization	Q'SAI Co., LTD.
Division name	Research and Development Department
Zip code
Address	1-7-16 Kusagae, Chuo-ku, Fukuoka-shi, Japan 810-8606
TEL	092-724-0855
Email	kurokawa@kyusai.co.jp

Public contact
Name of contact person	1st name Middle name Last name Takashi Nakagawa
Organization	TTC Co.,Ltd
Division name	Clinical Research Planning Department
Zip code
Address	Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	t.nakagawa@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co.,Ltd
Institute
Department

Funding Source
Organization	Q'SAI CO., LTD.
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 06 Month 30 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 06 Month 14 Day
Date of IRB	2018 Year 06 Month 14 Day
Anticipated trial start date	2018 Year 07 Month 02 Day
Last follow-up date	2018 Year 12 Month 22 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 06 Month 29 Day
Last modified on	2021 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037847