UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of the effects of 8-week continuous ingestion of plant tuber extract on knee joint: a double-blind, randomized and parallel study
Acronym	Investigation of the effects of 8-week continuous ingestion of plant tuber extract on knee joint: a double-blind, randomized and parallel study
Scientific Title	Investigation of the effects of 8-week continuous ingestion of plant tuber extract on knee joint: a double-blind, randomized and parallel study
Scientific Title:Acronym	Investigation of the effects of 8-week continuous ingestion of plant tuber extract on knee joint: a double-blind, randomized and parallel study
Region	Japan

Condition
Condition	healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of the test food to knee joint and QOL in men and women aged 40 or over to under 75 who feel discomfort in the knee joints of either or both feet.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Japanese Knee Osteoarthritis Measure (JKOM)
Key secondary outcomes	Questionnaire The 25-question geriatric locomotive function scale Assess high sensitivity C-reactive protein Hematologic test, Blood biochemical test Urine analysis Adverse events Number of occurrences of side effects Height, weight, BMI, blood pressure, pulse rate Other associated symptoms

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	Treatment
Type of intervention	Food
Interventions/Control_1	plant tuber extract 210 mg, 8weeks
Interventions/Control_2	Placebo, 8weeks
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) Subjects who aged more than 40 years, less than 75 years. (at the time of submission of an informed consent) 2) Healthy subjects (who were judged as healthy individuals by the principal investigator) 3) Men and women 4) Subjects who have a discomfort in the knee joints of both feet or one foot. 5) Subjects whose question I in the JKOM questionnaire is more than 20 mm. 6) Subjects who can use smartphone.(who can use electronic diaries) 7) Subjects who do not intend to change or do not change everyday lifestyle habits during the study period. 8) Subjects who can continue to take test food for 8 weeks. 9) Subjects who can provide their written informed consent.
Key exclusion criteria	1) Currently in treatment with medical products. 2) Currently under exercise and diet treatment. 3) Currently visiting hospital for treatment of knee pain. 4) More than 2 of KL (Kellgren-Lawrence) classification grade. 5) Diagnosed with hyperuricemia and the possible occurrence of an attack of gout. 6) Diagnosed with severe disorders such as diabetes, a circulatory disease, a hepatic disease, a renal disease and a cardiac disease, or previous history. 7) Positive at rheumatoid factor, or may cause pain from rheumatism. 8) Undergone or need knee surgery. 9) Need for pharmacological articular treatments during the study. 10) Undergone a hyaluronic acid injection within two weeks before the selection or a steroid injection within three months before the selection. 11) Diagnosed with bone or joint-related diseases such as a fracture and a sprain within the past three months. 12) Regular intake of health food that contains hyaluronic acid, glucosamine, chondroitin sulfuric acid, quercetin glycoside, vitamin D, or an amino-acid drug, or have the intention of consuming the health food during the study. 13) Regular intake of a medical products with an influence on the evaluation of the study (particularly, a medical products that contains glucosamine, chondroitin sulfuric acid, vitamin D or an amino-acid drug, or a medical products for the treatment of osteoporosis). 14) Excessive alcohol (over 60 g per day) intake. 15) Regular use of a cane. 16) Medical history of drug or food allergy. 17) Having the potential to become pregnant during the study or currently pregnant (including a possibility of being pregnant) or nursing. 18) Currently or history of drug abuse. 19) More than 30 kg / m2 of BMI. 20) Participated in other clinical trials within a month from the date of obtaining consent, or during the study. 21) Matched with exclusion criteria, since submission of an informed consent. 22) Unsuitable for enrollment in the opinion of the principal or sub investigator.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Marie Middle name Last name Kosehira
Organization	Omnica Co.,Ltd
Division name	Research Dept.
Zip code	1120002
Address	TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN
TEL	03-5840-9815
Email	kosehira@omnica.co.jp

Public contact
Name of contact person	1st name Marie Middle name Last name Kosehira
Organization	Omnica Co.,Ltd
Division name	Research Dept.
Zip code	1120002
Address	TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN
TEL	03-5840-9815
Homepage URL
Email	kosehira@omnica.co.jp

Sponsor
Institute	IMEQRD Co., Ltd
Institute
Department

Funding Source
Organization	Omnica 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	Suda Clinic institutional review board
Address	2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel	03-6205-6222
Email	suda-clinic_irb@imeq.co.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	医療法人社団浩央会　東小金井さくらクリニック

Other administrative information
Date of disclosure of the study information	2019 Year 07 Month 31 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	2019 Year 06 Month 25 Day
Date of IRB	2019 Year 06 Month 25 Day
Anticipated trial start date	2019 Year 08 Month 01 Day
Last follow-up date	2019 Year 10 Month 06 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 07 Month 31 Day
Last modified on	2019 Year 07 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042471