UMIN-CTR Clinical Trial

Public title

Effects of test food consumption on stress in healthy Japanese

Acronym

Effects of test food consumption on stress in healthy Japanese

Scientific Title

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

Scientific Title:Acronym

Effects of test food consumption on stress 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 psychological stress 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 Total Mood Disturbance (TMD) at eight weeks after the intervention (8w) (after psychological stress loading)

Key secondary outcomes

1. Change and percentage change in TMD from screening (after psychological stress loading) to 8w (after psychological stress loading)

2. Measured value of TMD at four weeks after the intervention (4w) and 8w (before psychological stress loading), as well as changes and percentage changes from screening (before psychological stress loading)

3. Change and percentage change in TMD from screening (before-to-after psychological stress loading) to 8w (before-to-after psychological stress loading)

4. Measured values of Anger-Hostility (AH), Confusion-Bewilderment (CB), Depression-Dejection (DD), Fatigue-Inertia (FI), Tension-Anxiety (TA), Vigor-Activity (VA), Friendliness (F), subjective fatigue, and salivary cortisol at 8w (after psychological stress loading), as well as changes and percentage changes from screening (after psychological stress loading)

5. Measured values of AH, CB, DD, FI, TA, VA, F, subjective fatigue, and salivary cortisol at 4w and 8w (before psychological stress loading), as well as changes and percentage changes from screening (before psychological stress loading)

6. Measured values of AH, CB, DD, FI, TA, VA, F, subjective fatigue, and salivary cortisol at 8w (before-to-after psychological stress loading), as well as changes and percentage changes from screening (before-to-after psychological stress loading)

7. Measured values of Depression score, Anxiety score, and Stress score of the Depression Anxiety Stress Scales-21 (DASS-21); total score of the Beck Depression Inventory-Second Edition (BDI2); and total score, Somatic Symptoms (A scale), Anxiety and Insomnia (B scale), Social Dysfunction (C scale), and Severe Depression (D scale) of the General Health Questionnaire-28 (GHQ-28) 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

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 whose TMD score of the Profile of Mood States 2nd Edition (POMS2) increased after psychological stress loading at screening

6. Individuals among those who met inclusion criteria No. 1-5 and did not meet any of the exclusion criteria, whose TMD score in the POMS2 is relatively high after psychological stress loading at screening

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

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

9. Individuals who have irregular lifestyles (such as diet, exercise, and sleep)

10. Individuals who are undergoing medical treatment for chronic fatigue syndrome or menopausal syndrome

11. Individuals who work in physical labor such as transportation of heavy objects

12. Individuals who 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)}

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

14. 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

15. Individuals who 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/ctr_e/ctr_view.cgi?recptno=R000068274