UMIN-ICDS Clinical Trial

Public title

Effects of test food consumption on sleep in healthy Japanese

Acronym

Effects of test food consumption on sleep in healthy Japanese

Scientific Title

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

Scientific Title:Acronym

Effects of test food consumption on sleep 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 test food consumption on sleep 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 the total score on the Athens Insomnia Scale (AIS) at eight weeks after the intervention (8w)

Key secondary outcomes

1. Change and percentage change in the total score on the AIS from screening to 8w

2. Measured value of the total score on the AIS at four weeks after the intervention (4w), as well as change and percentage change from screening

3. Measured values of "sleepiness on rising," "initiation and maintenance of sleep," "frequent dreaming," "refreshing," "sleep length" and each item in the OSA sleep inventory MA version (OSA-MA); and the total score on the Epworth Sleepiness Scale (ESS) at 4w and 8w, as well as changes and percentage changes from screening

4. Individuals whose responses to each item of the AIS and the ESS improved by at least one grade at 4w and 8w compared with screening

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

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: Capsule containing Lactococcus cremoris subsp. cremoris YRC3780 powder
Administration: Take one capsule with water without chewing per day.

*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: Capsule not containing Lactococcus cremoris subsp. cremoris YRC3780 powder
Administration: Take one capsule with water without chewing per day.

*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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Japanese

2. Men or women

3. Adults

4. Healthy individuals

5. Individuals among those who provided informed consent, met inclusion criteria No. 1~4, and did not meet any of the exclusion criteria, whose AIS score is six or higher at screening

Key exclusion criteria

Individuals 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 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, or any other chronic diseases

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

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

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

7. have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues

8. have irregular sleeping time or habit due to work such as a late-night shift

9. live with their infants less than one year old

10. sleep with their children (1 to 6 years old)

11. live with requiring long-term care persons

12. sleep with more than one person

13. have nocturia three times or more

14. drink to excess (average of more than about 20 g/day as pure alcohol intake)

15. have irregular lifestyles (such as diet, exercise, and sleep)

16. are undergoing medical treatment for chronic fatigue syndrome, menopausal syndrome, sleep apnea syndrome, or any other sleep disorders

17. work in physical labor such as transportation of heavy objects

18. are undergoing medical treatment or have a medical history of sleep disorder or sleep apnea syndrome

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

20. 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

21. are judged as ineligible to participate in this study by the physician

Target sample size

100

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

04

Month

27

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/icdr_e/ctr_view.cgi?recptno=R000068275