UMIN-CTR Clinical Trial

Basic information
Public title	A verification study of the improvement effects of the test food on mouth dryness
Acronym	A verification study of the improvement effects of the test food on mouth dryness
Scientific Title	The effects of the test food on the mouth dryness in healthy Japanese subjects: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym	The effects of the test food on the mouth dryness in healthy Japanese subjects
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 the test food on the mouth dryness.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The amount of changes of visual analogue scale (VAS) values of subjective mouth dryness between at screening (before test-food consumption; Scr) and 8 weeks after the start of test-food consumption (8w)
Key secondary outcomes	1. The amount of changes of VAS values in the subjective symptom of mouth dryness between at Scr and 4 weeks after the start of test-food consumption (4w) 2. The amount of changes in the following items between at Scr and 4w, and 8w VAS values of subjective symptoms of longing for drinking, difficulty eating and oral consistency; the volume of saliva; salivary amylase concentration; oral moisture values; and volatile sulfur compounds in the oral cavity 3. The logarithmic transformation values or the amount of changes in the following items between at Scr and 4w, and 8w Porphyromonas gingivalis, Tannerella forsythia and Treponema denticola 4. The ratio of subjects whose measured VAS values of subjective mouth dryness at 8w decreasing by 50% or more compared to Scr. 5. The ratio of subjects whose measured VAS values of subjective mouth dryness at 8w decreasing by 25% or more compared to Scr. 6. The ratio of subjects whose oral moisture level 8w decreasing compared to Scr. 7. The ratio of subjects whose oral moisture values at 8w is 28.0 or more.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 8 weeks Test food: Test food Administration: Take 1 tablet, three times a day. * If you forget to take the tablet, take it as soon as you remember within the day.
Interventions/Control_2	Duration: 8 weeks Test food: Placebo Administration: Take 1 tablet, three times a day. * If you forget to take the tablet, take it as soon as you remember within the day.
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 2. Subjects who feel thirsty in the mouth 3. Subjects who are judged as ineligible to participate in the study by the physician 4. Subjects whose saliva test (Saxon test) is 2 g or more in 2 minutes 5. Subjects whose oral moisture level [using Mucus (R)] is relatively low 6. Subjects whose VAS values of subjective mouth dryness is relatively high
Key exclusion criteria	Subjects who 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. are undergoing medical treatment or have a medical history of a salivary gland disorder (including sialadenitis, sialolithiasis, Sjogren's syndrome, and salivary gland tumors), or Subjects who removed a salivary gland 4. are undergoing medical treatment of autoimmune disease 5. are currently undergoing treatment for the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, and/or any other chronic diseases 6. use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 7. are currently taking medicines (include herbal medicines) and supplements 8. buy more than 2 packs of 9 chewing gum sheets or 14 to 20 chewing gum a month, or eat about 40 chewing gum a month 9. are smokers 10. use implants, tooth caps, dentures, and bridges 11. have received treatment of periodontosis or with antimicrobial drugs (including antibacterial drugs) within the last three months 12. have receiving dental maintenance care, such as removing dental plaques and dental tartars within the last three months 13. are under treatment or diagnosed with any of dental diseases 14. regularly use floss, interdental cleaner, and mouthwash 15. are allergic to medicines and/or the test food related products 16. are pregnant, lactation, or planning to become pregnant 17. 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 18. are judged as ineligible to participate in the study by the physician
Target sample size	52

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	Toyo Sugar Refining 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	2019 Year 11 Month 12 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	56
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 10 Month 25 Day
Date of IRB	2019 Year 10 Month 25 Day
Anticipated trial start date	2019 Year 11 Month 12 Day
Last follow-up date	2020 Year 02 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	2019 Year 11 Month 12 Day
Last modified on	2020 Year 03 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043906