UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046201
Receipt number R000052726
Scientific Title Effects of consumption of the test food on the halitosis in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Date of disclosure of the study information 2021/11/26
Last modified on 2023/02/06 15:36:09

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Basic information

Public title

Effects of consumption of the test food on the halitosis in healthy Japanese subjects

Acronym

Effects of consumption of the test food on the halitosis in healthy Japanese subjects

Scientific Title

Effects of consumption of the test food on the halitosis in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study

Scientific Title:Acronym

Effects of consumption of the test food on the halitosis 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 consumption of the test food on halitosis and psychological distress due to halitosis in healthy Japanese subjects

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

1. The total score of questionnaire for halitosis at eight weeks after consumption (8w)

Key secondary outcomes

1. The amount of change of the total score of questionnaire for halitosis between screening (before consumption; Scr) and 8w

2. The measured values and amount of change from Scr in each of the following items at 8w: the total scores of each domain of questionnaire for halitosis, the each question items of visual analog scale, the each score of Profile of Mood States 2nd Edition (POMS2) Japanese version {Total Mood Disturbance (TMD), Tension-Anxiety (TA), Depression-Dejection (DD), Anger-Hostility (AH), Vigor-Activity (VA), Fatigue-Inertia (FI), Confusion-Bewilderment (CB), and Friendliness (F)}, volatile sulfur compounds in the oral cavity, tongue coating score, oral moisture values, and the volume of saliva at rest

3. The measured values of each question items of POMS2 at 8w


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



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: Eight weeks
Test food: Tablet containing champignon extract
Administration: Take three tablets per day at any time during the day

* Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.

Interventions/Control_2

Duration: Eight weeks
Test food: Placebo tablet
Administration: Take three tablets per day at any time during the day

* Daily dose should be taken within the day. If you forget to take the test food, 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. Japanese

2. Male or female

3. Subjects aged 20 or more

4. Healthy subjects

5. Subjects who are anxious about halitosis

6. Subjects who are judged as eligible to participate in the study by the physician

7. Subjects whose total score of questionnaire for halitosis is between 14 and 21 at Scr

Key exclusion criteria

1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction

2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Subjects currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use

5. Subjects who regularly use antimicrobial drugs

6. Subjects currently taking medicines (include herbal medicines) and supplements

7. Subjects who are allergic to medications and/or the test-food-related products

8. Subjects who regularly use mouthwashes

9. Subjects who use artificial tooth, post crowns, dentures, implants, and bridges

10. Subjects who have receiving dental maintenance care at dental clinic, such as removing dental plaques and dental tartars within the last three months

11. Subjects who have a medical history, current illness, or are suspected to be a Sjogren's syndrome

12. Subjects who suffer from disorders associated with salivary gland such as dry mouse and salivary stone disease

13. Subjects who are being treated periodontosis or dental caries

14. Subjects whose salivary secretion volume at rest is less than 1.0 g/10 min

15. Subjects who are smokers

16. Subjects who are pregnant, breast-feeding, and planning to become pregnant

17. Subjects who suffer from COVID-19

18. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial

19. Subjects who are judged as ineligible to participate in the study by the physician

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Tsuyoshi
Middle name
Last name Takara

Organization

Medical Corporation Seishinkai, Takara Clinic

Division name

Director

Zip code

141-0022

Address

9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan

TEL

03-5793-3623

Email

t-takara@takara-clinic.com


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 or person

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name



Funding Source

Organization

Greenhouse Co., Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

Medical Corporation Yuseikai, Horiuchi Dental 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

IRB@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)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

医療法人社団優正会 堀内歯科医院 (東京都)
Medical Corporation Yuseikai, Horiuchi Dental Clinic (Tokyo, Japan)


Other administrative information

Date of disclosure of the study information

2021 Year 11 Month 26 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

66

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

2021 Year 11 Month 17 Day

Date of IRB

2021 Year 11 Month 17 Day

Anticipated trial start date

2021 Year 11 Month 24 Day

Last follow-up date

2022 Year 06 Month 05 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 11 Month 26 Day

Last modified on

2023 Year 02 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052726


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name