UMIN-CTR Clinical Trial

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

Healthy Japanese subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

Toyo Sugar Refining Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2019

Year

11

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2019

Year

11

Month

12

Day

Last modified on

2020

Year

03

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043906