UMIN-CTR Clinical Trial

Public title

Verification study of foods containing plant extracts in improving sleep problems

Acronym

Verification study of foods containing plant extracts in improving sleep problems

Scientific Title

Verification study of foods containing plant extracts in improving sleep problems

Scientific Title:Acronym

Verification study of foods containing plant extracts in improving sleep problems

Region

Japan

Condition

healthy person

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To clarify the effects of Tongkat Ali on sleep in healthy Japanese adult males aged 40-60 years old who are regularly dissatisfied with their sleep, objective measurement of sleep using EEG and other bioelectrical potential measurements from bedtime to waking and the OSA Sleep Questionnaire MA version to measure the feeling of sleep upon waking.Subjective evaluation of sleep using the OSA Sleep Questionnaire MA version to measure the feeling of sleep upon waking.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1. The average values of the parameters related to the quantity and quality of sleep obtained from the results of EEG sleep easurements for each subject for each of the three nights will be calculated, and the relationship between the intake of the test food and the subjects will be evaluated according to these average values.

Key secondary outcomes

1. The average values of the subjective sleep quality parameters scored by the MA version of the OSA Sleep Questionnaire will be calculated for each of the 3 days, and the relationship with the presence or absence of the test food intake will be evaluated by comparing these average values.
2. The scores of each subject on the Brief Stress Level Checklist, the General Mood State (POMMS2), the Health-related Quality of Life Scale (SF-8), the Fatigue Rating Scale (CFS), the Depressed Mood Scale (DASS), the Epworth Sleepiness Scale (ESS), and the Athens Insomnia Scale (AIS) were compared with those of the subjects who had consumed the test food.The relationship between the presence and absence of the test food intake will be evaluated.

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

During the intervention period, Group A (30 subjects) will each consume their assigned test product daily after breakfast.They will also record their intake status and various subjective symptoms in a subject diary every day during the intervention period.Three days before, four weeks after, and three days after the consumption of the test product, respectively, an objective evaluation of sleep using EEG and other bioelectrical potential measurements and a subjective evaluation of sleep using the Sleep Sensation upon Awakening Questionnaire (OSA-MA) will be conducted.On the day following the last day of each 3-day EEG measurement, participants will respond to each of the following questionnaires: Simple Stress Level Checklist, General Mood State (POMMS2), Health-related Quality of Life Scale (SF-8), Fatigue Rating Scale (CFS), Depressed Mood Scale (DASS), and Epworth Sleepiness Scale (ESS).

Interventions/Control_2

During the intervention period, Group B (30 subjects) will each consume their assigned test product daily after breakfast.They will also record their intake status and various subjective symptoms in a subject diary every day during the intervention period.Three days before, four weeks after, and three days after the consumption of the test product, respectively, an objective evaluation of sleep using EEG and other bioelectrical potential measurements and a subjective evaluation of sleep using the Sleep Sensation upon Awakening Questionnaire (OSA-MA) will be conducted.On the day following the last day of each 3-day EEG measurement, participants will respond to each of the following questionnaires: Simple Stress Level Checklist, General Mood State (POMMS2), Health-related Quality of Life Scale (SF-8), Fatigue Rating Scale (CFS), Depressed Mood Scale (DASS), and Epworth Sleepiness Scale (ESS).

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

40

years-old

<=

Age-upper limit

60

years-old

>

Gender

Male

Key inclusion criteria

1. Those whose score on the Athens Insomnia Scale is 6 points or higher.
2. Those who are able to come to the examination site on the designated date.
3. Persons who are willing to give written consent to participate in this study.

Key exclusion criteria

1. Those who are currently receiving treatment (including medication)for any disease.
2. Those who have been diagnosed with sleep disorders such as insomnia or sleep apnea, and are taking drugs such as sleep inducers or insomnia medications (including OTC drugs as well as prescription drugs),or are receiving treatment with CPAP or mouthpieces, etc.
3. Those who have been diagnosed and treated for allergic diseases such as atopic dermatitis, asthma, allergic rhinitis, or nocturia.
4. Consume foods for specified health use, foods with functional claims, or other foods/beverages with possible functional properties on a regular basis.
5. Those whose BMI exceeds 30(severely obese)
6. Those who are mainly in charge of taking care of those who need nursing care or infants.
7. Those who work late at night, shift work, or heavy labor.
8. Pregnant, lactating, or intending to become pregnant.
9. Those who cannot sleep alone on a single bedding(futon or bed, etc.)during the research period.
10. who sleeps less than 6 hours per night(calculated based on their reported normal bedtime and waking time).

Items that cannot be listed in the Exclusion Criteria column are listed in Other Relevant Information.

Target sample size

60

Name of lead principal investigator

1st name	Satoshi
Middle name
Last name	Sakurai

Organization

Clinical Creative Corporation

Division name

Pharmaceuticals Division

Zip code

353-0001

Address

4-1-37 Kamimuneoka, Shiki-shi, Saitama

TEL

090-6700-4850

Email

s-sakurai@cli-creative.com

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

09031166218

Homepage URL

Email

k-ohno@cli-creative.com

Institute

Clinical Creative Co., Ltd.

Institute

Department

Personal name

Organization

DELIGHTEX PTE. LTD.

Organization

Division

Category of Funding Organization

Self funding

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, 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

2025

Year

02

Month

20

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

Completed

Date of protocol fixation

2024

Year

11

Month

21

Day

Date of IRB

2025

Year

01

Month

08

Day

Anticipated trial start date

2025

Year

02

Month

20

Day

Last follow-up date

2025

Year

05

Month

03

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

11. Those who are not able to comply with the gentle sleep control(going to bed within+-2 hours of the reported bedtime and waking within +-2 hours of the reported waking time)during the study period, or those who are not sleeping regularly.
12. Persons who cannot avoid drinking alcohol and consuming caffeinated beverages(sencha, black tea, coffee, caffeinated beverages, etc.)after 6 p.m. during the EEG measurement period and the day before the measurement period.
13. Consumers who constantly drink more than the appropriate amount of alcohol(average daily alcohol consumption of approximately 20 g of pure alcohol or less*).
14. Persons who engage in extremely low levels of activity and exercise during the day
15. Persons who are unable to complete the EEG measurement and each questionnaire according to the schedule.
16. Participation in other clinical studies in the month prior to the date of obtaining consent, or planned participation in other clinical studies during the study period
17. Persons who have traveled abroad within 2 weeks prior to the date of obtaining consent or are planning to travel abroad during the study period.
18. Any other person who is judged by the physician to be inappropriate to participate in this study(including those who show extremely abnormal values in biochemical tests).

Registered date

2025

Year

02

Month

12

Day

Last modified on

2025

Year

08

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065150