UMIN-CTR Clinical Trial

Public title

Study to Confirm the Stress-Reducing Effects of Test Food Consumption
A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparison Study

Acronym

Study to Confirm the Stress-Reducing Effects of Test Food Consumption
A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparison Study

Scientific Title

Study to Confirm the Stress-Reducing Effects of Test Food Consumption
A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparison Study

Scientific Title:Acronym

Study to Confirm the Stress-Reducing Effects of Test Food Consumption
A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparison Study

Region

Japan

Condition

Male/female adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To compare and evaluate the stress-reducing effects and safety of consuming the test food, using a placebo as the control.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Stress Levels (measured by Stress Visual Analog Scale (VAS), and Profile of Mood States 2nd Edition (POMS2) Japanese Full Version)

Key secondary outcomes

Saliva volume, Saliva tests (salivary cortisol, salivary amylase, salivary chromogranin A), Pittsburgh Sleep Quality Index (PSQI), Oguri-Shirakawa-Azumi Sleep Inventory MA version (OSA-MA), Epworth Sleepiness Scale (ESS), Sleep Visual Analog Scale (VAS), State-Trait Anxiety Inventory (STAI), Patient Assessment of Constipation Quality of Life (PAC-QOL), Gut microbiota analysis, Fecal organic acid analysis, Fecal putrefactive product analysis

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

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Consumption of the test food (1 capsule a day) for 8 weeks

Interventions/Control_2

Consumption of the placebo food (1 capsule a day) for 8 weeks

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

20

years-old

<=

Age-upper limit

60

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Men and women aged 20 to below 60 years at the time of consent acquisition.
2. Subjects whose body mass index (BMI) is under 30 kg/m ² .
3. Subjects who are aware of experiencing daily stress.
4. Subjects whose work schedule is typically Monday to Friday with weekends off (including those who have one weekday and one weekend day off).
5. Subjects who habitually go to bed by 24:00.
6. Subjects who are habitually dissatisfied with their sleep.
7. Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.

Key exclusion criteria

1. Subjects who regularly consume Food for Specified Health Uses (FOSHU), Foods with Functional Claims, or health supplements (including those containing GABA, L-theanine, citric acid, etc.) that may affect stress, sleep, or intestinal health, three or more times per week and cannot stop consuming them from the time of consent.
2. Subjects who are taking medications (including antibiotics, intestinal regulators, laxatives, sleep aids, etc.) that may affect stress, sleep, or intestinal health, and cannot restrict their use from the time of consent.
3. Subjects who are participating in the other clinical trials and/or who have participated in the other clinical trials within 4 weeks prior to the current trial and/or who are planning to participate in the other clinical trials.
4. Subjects with severe rhinitis or hay fever that affects sleep.
5. Subjects diagnosed with dry mouth.
6. Subjects who cannot abstain from alcohol from the start of the pre-observation period.
7. Subjects with excessive alcohol intake.
8. Subjects who have smoking habit.
9. Subjects with irregular lifestyles due to shift work, night work, or highly variable workloads.
10. Subjects planning major lifestyle changes from the time of consent acquisition.
11. Subjects with nocturia (two or more times per night).
12. Subjects without an environment where they can use bedding alone.
13. Subjects living in an environment where their sleep may be involuntarily disturbed (such as living with caregivers, infants, or pets).
14. Subjects with a history or current diagnosis of depression or other mental disorders.
15. Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs.
16. Females who are pregnant or lactating, and females who could become pregnant from the time of consent acquisition.
17. Subjects with allergies to medications and/or food.

Target sample size

140

Name of lead principal investigator

1st name	Fumiko
Middle name
Last name	Nakamura

Organization

CPCC Company Limited

Division name

Clinical Support Department

Zip code

103-0021

Address

4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan

TEL

03-6225-9001

Email

cpcc-contact@cpcc.co.jp

Name of contact person

1st name	Masanori
Middle name
Last name	Numa

Organization

CPCC Company Limited

Division name

Clinical Planning Department

Zip code

103-0021

Address

4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan

TEL

03-6225-9001

Homepage URL

Email

cpcc-contact@cpcc.co.jp

Institute

CPCC Company Limited

Institute

Department

Personal name

Organization

MEGMILK SNOW BRAND Co.,Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan

Tel

03-6225-9005

Email

IRB@cpcc.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

08

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

140

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

No longer recruiting

Date of protocol fixation

2024

Year

07

Month

22

Day

Date of IRB

2024

Year

07

Month

19

Day

Anticipated trial start date

2024

Year

08

Month

11

Day

Last follow-up date

2025

Year

01

Month

12

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

(Exclusion criteria continued)
18. Subjects who donated blood or component (200 mL) within the last 1 months.
19. Subjects who donated his blood (400 mL) within the last 3 months.
20. Subjects who donated her blood (400 mL) within the last 4 months.
21. Subjects who being collected in total of his blood (1200 mL) within the last 12 months and in this study.
22. Subjects who being collected in total of her blood (800 mL) within the last 12 months and in this study.
23. Subjects deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.

Registered date

2024

Year

08

Month

09

Day

Last modified on

2024

Year

10

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062789