UMIN-CTR Clinical Trial

Basic information
Public title	A verification study of improving on the oral cavity environment of the test food: an open-label trial
Acronym	A verification study of improving on the oral cavity environment of the test food
Scientific Title	A verification study of improving on the oral cavity environment of the test food: an open-label trial
Scientific Title:Acronym	A verification study of improving on the oral cavity environment of the test food
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 of consumption of the test food for 4 weeks on the oral cavity environment in healthy Japanese subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	A. actinomycetemcomitans, P. gingivalis, P. intermedia, T. forsythensis, T. denticola, F. nucleatum * Measure the values at screening (before consumption) and 4 weeks after consumption.
Key secondary outcomes	1. Visual Analogue Scale (VAS) of subjective symptoms Halitosis, swelling of gums, surface roughness of tooth, oral discomfort, dry mouth, and, stickiness in the mouth 2. The concentration of serum IGF-1 3. The concentration of salivary IGF-1 * Measure the values at screening (before consumption) and 4 weeks after consumption.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 4 weeks Test materials: HGH crystal Dose: 1 pack, three times per day Administration: Maintain the test food in the mouth for 40 seconds and swallow it before each meal. * If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2
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 who have no tooth decay. 2. Subjects who are judged as eligible to participate in the study by the physician.
Key exclusion criteria	1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure or myocardial infarction. 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD). 3. 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. 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily. 5. Subjects who are currently taking medications (including herbal medicines) and dietary supplements. 6. Subjects who are identified at least severe tooth decay by dentist. 7. Subjects who use implants, tooth caps, dentures, and bridges. 8. Subjects who have received treatment of periodontosis or with antimicrobial drugs (including antibacterial drugs) within the last three months. 9. Subjects who have received dental maintenance care, such as removing dental plaques and dental tartars within the last three months. 10. Subjects who are under treatment or diagnosed with any of dental diseases. 11. Subjects who regularly use floss, interdental cleaner, and mouthwash. 12. Subjects who are allergic to medicines and/or the test food related products. 13. Subjects who are pregnant, breast-feeding, or planning to become pregnant. 14. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial. 15. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician.
Target sample size	27

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
Zip code	112-0002
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 Naoko Middle name Last name SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Zip code	112-0002
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	Autobahn Co. Ltd.
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	the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address	9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel	03-5793-3623
Email	info@takara-clinic.com

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 12 Month 28 Day

Related information
URL releasing protocol	Unpublished
Publication of results	Published

Result
URL related to results and publications	http://www.pieronline.jp/content/article/0386-3603/47080/1297
Number of participants that the trial has enrolled	27
Results	Morinaga H, Tanaka M. HGH Crystal MD(R) Improves the Oral Environment-An Open-label,Observational Before-after Study-. Jpn Pharmacol Ther. 2019; 47(8): 1297-1313.
Results date posted	2021 Year 05 Month 27 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2019 Year 08 Month 30 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 12 Month 18 Day
Date of IRB	2018 Year 12 Month 18 Day
Anticipated trial start date	2018 Year 12 Month 29 Day
Last follow-up date	2019 Year 03 Month 29 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 12 Month 28 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=R000040329