UMIN-CTR Clinical Trial

Public 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

Acronym

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

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

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

Key secondary outcomes

1. The measured value of "sleepiness on rising" in the OSA-MA at 4 and 8 weeks after consumption (4w, 8w)

2. The amount and rate of change of "sleepiness on rising" in the OSA-MA between screening (before consumption; Scr) and 4w, 8w, or 12w

3. The measured values of the "initiation and maintenance of sleep", "frequent dreaming", "refreshing", and "sleep length" in the OSA-MA at 4w, 8w, and 12w, and the amount and rate of changes of them from Scr

4. Each item in the OSA-MA at 4w, 8w, and 12w

5. The measured values of the total score, C1, C2, C3, C4, C5, C6, and C7 in the Pittsburgh Sleep Quality Index (PSQI-J) at 4w, 8w, and 12w, and the amount and rate of changes of them from Scr

6. Each item in the PSQI-J at 4w, 8w, and 12w

7. The measured value of the fatigue measured by visual analogue scale (VAS) at 12w, and the amount and rate of change of it from Scr

8. The measured values of the 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) in the Profile of Mood States 2nd Edition (POMS2) at 12w, and the amount and rate of changes of them from Scr

9. Each item in the POMS2 at 12w

10. The measured values of the salivary amylase and tympanic membrane temperature at 12w, and the amount and rate of changes of them from Scr

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: 12 weeks
Test food: Tablet containing sake lees enzyme
Administration: Take five tablets with water between two hours and one hour before sleep

*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: 12 weeks
Test food: Placebo tablet
Administration: Take five tablets with water between two hours and one hour before sleep

*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 subjects

5. Subjects who are judged as eligible to participate in the study by the physician according to the results of the Beck depression inventory (BDI-II) at Scr

6. Subjects who have low "sleepiness on rising" (Zc score) in the OSA-MA among those meeting No.1~5 of the inclusion criteria and not meeting the exclusion criteria at Scr (Screening of subjects who have "sleepiness on rising" (Zc score) in the OSA-MA will be conducted for each of the following stratum: "men aged 40 or more", "men aged less than 40", "women aged 40 or more", and "women aged less than 40")

Key exclusion criteria

Subjects (who/whose)
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
3. currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily
5. currently 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 trial
8. 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
9. are judged as ineligible to participate in this study by the physician
10. live with their infants less than one year old
11. sleep with their children (1 to 6 years old)
12. live with and need to care for those in requiring long-term care
13. sleep with more than one person
14. sleeping time or habit is irregular due to work such as a late-night shift
15. have nocturia two times or more
16. have irregular lifestyles (such as inconstant eating time, insufficient sleeping time)
17. usually 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)}
18. are undergoing treatment of insomnia or sleep disorder, or take sleep-inducing drugs or other medications
19. take food/beverage containing functional ingredients which may influence sleep quality (such as gamma-aminobutyric acid, crocetin, L-theanine, and lactic acid bacteria)

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

MAINICHIEGAO. 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

07

Month

05

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

06

Month

14

Day

Date of IRB

2023

Year

06

Month

14

Day

Anticipated trial start date

2023

Year

07

Month

05

Day

Last follow-up date

2023

Year

12

Month

28

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

07

Month

05

Day

Last modified on

2024

Year

04

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058783