UMIN-CTR Clinical Trial

Basic information
Public title	A randomized, double-blind, placebo- controlled, parallel-group study on the effect of N-acetylglucosamine on discomfort in the knee.
Acronym	Effect of N-acetylglucosamine on discomfort in the knee.
Scientific Title	A randomized, double-blind, placebo- controlled, parallel-group study on the effect of N-acetylglucosamine on discomfort in the knee.
Scientific Title:Acronym	Effect of N-acetylglucosamine on discomfort in the knee.
Region	Japan

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

Objectives
Narrative objectives1	To examine the effects of N-acetylglucosamine ingestion for 12 weeks on discomfort in the knee.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	JOA Score
Key secondary outcomes	JKOM Scor, Knee joint subjective symptoms (VAS), KS Score, J-KOOS Interview, Body weight, Blood pressure, Pulse rate, Subjective and objective symptoms, Adverse events, Hematologic test, Blood biochemistry test, Urine analysis

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	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Ingestion of supplement containing N-acetylglucosamine for 12 weeks.
Interventions/Control_2	Ingestion of placebo without N-acetylglucosamine for 12 weeks.
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. Healthy males and females aged 20 to 69 years old 2. Subjects who experience discomfort or pain in the knee and are classified into 0-I grade based on the Kellgren-Lawrence classification 3. Individuals who can make self-judgment and are voluntarily giving written informed consent
Key exclusion criteria	1. Individuals who are under treatment, have a history, or are suspected to have rheumatoid arthritis 2. Individuals who need treatment and medication for osteoarthritis 3. Individuals with history of surgical therapy (artificial joint) on knees. 4. Individuals who continuously use compress, topical cream, and/or analgesic agent etc. on knee region 5. Individuals who have injury of semi-lunar disc or the other knee joint disease 6. Individuals who are under treatment of serious chronic diseases e.g., liver disease, heart and/or vascular disease, respiratory disorder, endocrine disorder, or metabolic diseases 7. Individuals who cannot stop using supplements and/or functional foods affecting knee cartilage 8. Individuals who have a history of food allergy 9. Individuals who hope for pregnancy in the test duration, pregnant women, lactating women 10. Individuals who are planning to participate or already participating in other clinical studies 11. Individuals who are judged as unsuitable for the study by the investigator for other reasons
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yasuo Middle name Last name Kobuna
Organization	Kobuna Orthopedics Clinic
Division name	Director
Zip code	371-0813
Address	311-2 Gokan-machi, Maebashi-shi, Gumma 371-0813, Japan
TEL	027-261-7600
Email	info@kobunaseikei.jp

Public contact
Name of contact person	1st name Eiji Middle name Last name Yoshikawa
Organization	KSO Corporation
Division name	Sales department
Zip code	105-0023
Address	1-9-7 Shibaura, Minato-ku, Tokyo 105-0023, Japan
TEL	03-3452-7733
Homepage URL
Email	yoshikawa@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	Yaizu Suisankagaku Industry 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	Ethical Committee of Kobuna Orthopedics Clinic
Address	5-656-17 Joutou-machi, Maebashi-shi, Gunma, Japan
Tel	027-212-5608
Email	sagawa@mc-connect.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

Other administrative information
Date of disclosure of the study information	2019 Year 12 Month 15 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	100
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	2019 Year 12 Month 04 Day
Date of IRB	2019 Year 12 Month 05 Day
Anticipated trial start date	2019 Year 12 Month 16 Day
Last follow-up date	2020 Year 04 Month 18 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 12 Month 12 Day
Last modified on	2020 Year 12 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044315