UMIN-CTR Clinical Trial

Public title

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

Acronym

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

Scientific Title

Effects of consumption of the test food on sleep quality 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 sleep quality 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 12-week consumption of the test food on sleep quality in healthy Japanese subjects

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

"Sleepiness on rising" in the OSA sleep inventory MA version (OSA-MA) at 12 weeks after consumption (12w)

Key secondary outcomes

"Initiation and maintenance of sleep", "frequent dreaming", "refreshing", "sleep length", and each item in the OSA-MA at 12w

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

Concealment

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: 12 weeks
Test food: Tablet containing ripened Korean red ginseng extract (108 mg/tablet)
Administration: Take two tablets with water 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: 12 weeks
Test food: Tablet containing ripened Korean red ginseng extract (162 mg/tablet)
Administration: Take two tablets with water 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

Duration: 12 weeks
Test food: Placebo tablet
Administration: Take two tablets with water 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_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 subjects

5. Subjects who are concerned about their sleep quality

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

7. Subjects whose the average of each score in the OSA-MA are relatively low at screening (before consumption; Scr)

Key exclusion criteria

Subjects

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

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

3. who 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. who are currently undergoing treatment of insomnia or sleep disorder

5. who are judged as depressive tendency by total score of Beck Depression Inventory-II (BDI2) at Scr

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

7. who currently taking medications (including herbal medicines) and supplements

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

9. who live with their infants less than one year old

10. who co-sleep with their children (one to six years old)

11. who live with requiring long-term care persons

12. who share the bed with more than one person

13. whose sleeping time or habit is irregular due to working a late-night shift

14. whose dinner time is extremely irregular

15. who have nocturia three times or more

16. who drink to excess (average of more than about 20 g/day as absolute 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. who are pregnant, lactation, or planning to become pregnant

18. who suffer from COVID-19

19. 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

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

Target sample size

99

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

KIM's Korean Ginseng 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 Building, 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

2022

Year

05

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

108

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

2022

Year

04

Month

20

Day

Date of IRB

2022

Year

04

Month

20

Day

Anticipated trial start date

2022

Year

04

Month

28

Day

Last follow-up date

2022

Year

12

Month

07

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

05

Month

10

Day

Last modified on

2024

Year

03

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054397