UMIN-CTR Clinical Trial

Public title

Effects of continuous consumption of the test food on salivary IgA secretion in healthy Japanese

Acronym

Effects of continuous consumption of the test food on salivary IgA secretion in healthy Japanese

Scientific Title

Effects of continuous consumption of the test food on salivary IgA secretion in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study

Scientific Title:Acronym

Effects of continuous consumption of the test food on salivary IgA secretion in healthy Japanese

Region

Japan

Condition

Healthy Japanese

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the effects of continuous consumption of the test food on salivary IgA secretion in healthy Japanese.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. Measured value of salivary immunoglobulin A (IgA) secretory rate at eight weeks after the intervention (8w)

Key secondary outcomes

1. Measured value of salivary IgA secretory rate at four weeks after intervention (4w)

2. Change and percentage change in salivary IgA secretory rate from screening to 4w and 8w

3. Measured values of saliva volume and salivary IgA level at 4w and 8w, as well as changes and percentage changes from screening

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Food

Interventions/Control_1

Duration: Eight weeks
Test product: Chewable tablet containing Lactococcus cremoris subsp. cremoris YRC3780 powder
Administration: Take one tablet once a day with water in the morning (within two hours after waking up).

*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.

Interventions/Control_2

Duration: Eight weeks
Test product: Chewable tablet not containing Lactococcus cremoris subsp. cremoris YRC3780 powder
Administration: Take one tablet once a day with water in the morning (within two hours after waking up).

*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next 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

60

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Japanese

2. Individuals aged >= 60 at the time of agreement to participate in this study

3. Men whose body weight is >= 50.1 kg, women whose body weight is >= 37.6 kg

4. Individuals whose BMI is >= 17.6 kg/m² and =< 29.9 kg/m²

5. Individuals who are able to discontinue the intake of other lactic acid bacteria-related foods and oligosaccharides during this study

6. Healthy individuals

Key exclusion criteria

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

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

3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, gastrointestinal disorder, congenital disease, or any other chronic diseases

4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"

5. Individuals who are taking or using medications (including herbal medicines) or supplements

6. Individuals who are allergic to medicines or foods related to the test product

7. Individuals who have diarrhea by consuming yogurt

8. Individuals who have used expectorants or antibiotics that affect IgA, or medicines that affect intestinal function, within one month prior to this study (those who use them during this study will be discontinued from participation)

9. Individuals who are diagnosed with dementia

10. Individuals who have been diagnosed with undernutrition

11. Individuals whose saliva volume is less than 1 mL even after more than 3 minutes of collection, or whose salivary flow rate is less than 100 mg per minute

12. Individuals who are pregnant, lactating, or planning to become pregnant during this study

13. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study

14. Individuals who are judged as ineligible to participate in this study by the physician

Target sample size

80

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

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

Yotsuba Milk Products Co., Ltd.

Institute

Department

Personal name

Organization

Yotsuba Milk Products Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

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

Tel

03-5793-3623

Email

IRB@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)

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

Date of disclosure of the study information

2025

Year

11

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

Open public recruiting

Date of protocol fixation

2025

Year

10

Month

22

Day

Date of IRB

2025

Year

10

Month

22

Day

Anticipated trial start date

2025

Year

11

Month

07

Day

Last follow-up date

2026

Year

03

Month

13

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2025

Year

11

Month

07

Day

Last modified on

2025

Year

11

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068276