UMIN-ICDS Clinical Trial

Public title

Improvement of the intestinal environment through food intake and its effect on sleep

Acronym

Improvement of intestinal environment, sleep study

Scientific Title

Improvement of the intestinal environment through food intake and its effect on sleep

Scientific Title:Acronym

Improvement of intestinal environment, sleep study

Region

Japan

Condition

healthy person

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To clarify the effects of cereal intake on the intestinal environment and sleep in healthy Japanese adult males and females between the ages of 18 and 60 who are exposed to stress and have a tendency to insomnia, we will evaluate the intestinal microflora by defecation, objectively evaluate sleep by measuring EEG and other biopotentials from bedtime to waking and subjectively evaluate sleep using a sleep questionnaire upon waking.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The mean values of each sleep parameter (total sleep time, sleep efficiency, sleep latency, mid-wake time, total and percentage of deep sleep time, etc.) before cereal intake (week 0) and at weeks 4 and 8 of intake, respectively, will be calculated and their changes over time evaluated to explore the relationship between cereal intake and sleep.

Key secondary outcomes

(1) Calculate the average values of the subjective sleep quality parameters as scored by the Subjective Sleep Assessment (OSA-MA) before cereal intake (week 0), week 4 and week 8 of intake, respectively, and evaluate the changes over time.
(2) Evaluate changes in gut microbiota and short-chain fatty acids to be measured before and at 4 and 8 weeks of cereal intake. (iii) Insomnia tendency and daytime sleepiness data (Athens Insomnia Scale and Epworth Sleepiness Scale Questionnaire) collected during the pre-survey, and the questionnaire on overall mood status (POMS2 short version) and defecation status collected during screening will be compared with the results at 4 and 8 weeks of cereal intake to evaluate changes over time. These three points will provide an exploratory assessment of the effects of cereal intake on the intestinal environment, subjective sleep ratings, and mood state and defecation status.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Consume 50 g of the test food for breakfast each day and record the daily diet.

Interventions/Control_2

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

60

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Those who have been fully informed of the purpose and content of this study, have the capacity to consent, and fully understand and agree to participate in this study in writing.
2 Japanese women between the ages of 18 and 60 at the time of consent
3 Those who are under high stress and have a tendency to insomnia or suspected insomnia according to the preliminary questionnaire survey. However, those with a high risk of being diagnosed as insomniacs will be excluded.

Key exclusion criteria

1. Those who have taken, or will take during the study period, any medication (e.g., antiallergic drugs, sleep inducing drugs, sleep aids, etc.) that may affect the study one month prior to the start of intake of the test food.
2. Those who regularly consume food for specified health use, functional foods, supplements, or health foods that may affect the study at least 3 times a week, and those who are unable to limit their intake during the study period.
3. Those with a history or current history of serious diseases of the heart, liver, kidney, digestive organs, etc.
4. Persons suspected of having a chronic or acute serious infectious disease.
5. Those who are scheduled to be vaccinated during the study period.
6. Pregnant or planning to become pregnant, and those who are breastfeeding.
7. Those who habitually drink alcohol more than 3 times a week and more than 1 sake equivalent (beer: 1 medium bottle, whiskey: 1 double, shochu: 0.6 gou).
8. Those who have an extremely irregular diet.
9. Have a BMI of 30 or higher
10. Those who plan to change their lifestyle drastically during the study period.
11. Persons who are primarily responsible for the care of nursing caregivers or infants, or whose sleep may be disturbed by other external factors (e.g., roommates or pets).
12. Persons who are allergic to food
13. Who are currently participating in a clinical study of another drug or health food, and who plan to participate in another clinical study within one month after the completion of the study, or after consent to participate in the study.
14. Those who are not engaged in a full-time occupation.
15. Those who work shift work or late-night work, have irregular sleeping or waking times, or sleep extremely short or irregular hours.
16. Do not have a smartphone.
17. Those who cannot install the Fitbit application on their smartphones.
18. Any other person who is deemed by the principal investigator to be inappropriate to participate in this study.

Target sample size

27

Name of lead principal investigator

1st name	Katsuyuki
Middle name
Last name	Ishihara

Organization

Calbee, Inc.

Division name

Research & Development Division

Zip code

321-3231

Address

23-6, Kiyohara-Kogyodanchi, Utsunomiya, Tochigi

TEL

080-5952-8671

Email

K_ishihara@calbee.co.jp

Name of contact person

1st name	Kazuhiro
Middle name
Last name	Ohno

Organization

Clinical Creative Co., Ltd.

Division name

Pharmaceutical Development Division

Zip code

003-0026

Address

2-18-201, 3-minami, Hondori 3-chome, Shiroishi-ku, Sapporo, Hokkaid

TEL

090-3116-6218

Homepage URL

Email

k-ohno@cli-creative.com

Institute

Clinical Creative Co., Ltd.

Institute

Department

Personal name

Organization

Calbee, Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Sapporo Yurinokai Hospital Clinical Trial Review Committee

Address

11-186 Yurigahara, Kita-ku, Sapporo-shi, Hokkaido

Tel

011-771-1501

Email

info@yurinokai.jp

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　札幌百合の会病院
Medical Corporation Association Sapporo Yurinokai Hospital

Date of disclosure of the study information

2024

Year

01

Month

08

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

Preinitiation

Date of protocol fixation

2023

Year

08

Month

30

Day

Date of IRB

2023

Year

11

Month

15

Day

Anticipated trial start date

2024

Year

02

Month

12

Day

Last follow-up date

2024

Year

05

Month

11

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

12

Month

21

Day

Last modified on

2023

Year

12

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060703