UMIN-CTR Clinical Trial

Public title

Effects of consumption of the test food on sleep in healthy Japanese

Acronym

Effects of consumption of the test food on sleep in healthy Japanese

Scientific Title

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

Scientific Title:Acronym

Effects of consumption of the test food 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 consumption of the test food on sleep in healthy Japanese.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. The measured value of total score in the Athens Insomnia Scale (AIS) at the in-clinic examination after eight weeks of consumption (8w)

Key secondary outcomes

1. The amount of change and rate of change from screening (at the in-clinic examination before consumption; Scr) of total AIS score at 8w

2. The measured value of total AIS score at home-based examination after four weeks of consumption (4w), and its amount and rate of change from Scr

3. The 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 total score in the Epworth Sleepiness Scale (ESS) at 4w and 8w, and the amount and rate of changes of them from Scr

4. The measured values of each item in the AIS and ESS at 4w and 8w

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

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: Eight weeks
Test food: Capsule containing Lactococcus lactis 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 food: Capsule not containing Lactococcus lactis 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 whose score of AIS is six or more and high at Scr among those who agreed to participate in this study and met the inclusion criteria 1~4, without meeting any of exclusion criteria

Key exclusion criteria

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

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

3. are currently undergoing treatment for 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 medications (including herbal medicines) and supplements

6. are allergic to medicines and/or the test food related products

7. are pregnant, lactating, or planning to become pregnant during this study

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

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

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

11. live with their infants less than one year old

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

13. live with requiring long-term care persons

14. sleep with more than one person

15. have nocturia three times or more

16. drink to excess (average of more than about 20 g/day as pure alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)}

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

18. are undergoing medical treatment for chronic fatigue syndrome or menopausal syndrome

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

20. 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

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

Yotsuba Milk Products Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

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

2023

Year

10

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

112

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

2023

Year

10

Month

18

Day

Date of IRB

2023

Year

10

Month

18

Day

Anticipated trial start date

2023

Year

10

Month

26

Day

Last follow-up date

2024

Year

04

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

10

Month

23

Day

Last modified on

2024

Year

07

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060004