UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053909 |
|---|---|
| Receipt number | R000061535 |
| Scientific Title | Dose-Finding Study of Food Products Containing Plant Extracts in Improving Sleep Distress |
| Date of disclosure of the study information | 2024/03/19 |
| Last modified on | 2024/03/19 23:02:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Dose-Finding Study of Food Products Containing Plant Extracts in Improving Sleep Distress
Acronym
Dose-Finding Trials in Improving Sleep Distress
Scientific Title
Dose-Finding Study of Food Products Containing Plant Extracts in Improving Sleep Distress
Scientific Title:Acronym
Dose-Finding Trials in Improving Sleep Distress
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of the test food on sleep in healthy Japanese adult males aged 40-60 years old who are regularly dissatisfied with their sleep, objective measurement of sleep by measuring EEG and other bioelectrical potentials from bedtime to waking and subjective evaluation of sleep using the OSA Sleep Survey MA version to measure the feeling of sleep upon waking The study will be conducted in order to determine the effect of the test foods on sleep improvement. In addition, the optimal effective dose for improving sleep with the test food will be examined.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The average values of the parameters related to the quantity and quality of sleep obtained from the results of EEG sleep measurements for each subject are calculated for each of the two nights before and after the intake of the test food, and these average values are used to evaluate the relationship between the intake of the test food and the dose.
Key secondary outcomes
The relationship between the presence and absence and dose of the test food intake will be evaluated by comparing each subject's Epworth Sleepiness Scale Questionnaire scores before and after two doses of the test food intake. In addition, the mean values of the subjective sleep quality parameters scored on the MA version of the OSA Sleep Questionnaire will be calculated for the two days before and after ingestion, respectively, and the relationship between the presence and absence of test food intake and dose will be evaluated by comparing these mean values.
Each subject's scores on each of the Health Related Quality of Life Scale (SF-8), Fatigue Rating Scale (CFS), Overall Mood State (POMS2), and Depressed Mood Rating Questionnaire will be compared before and after consumption of the test food and two doses to evaluate the relationship between the test food intake and the dose.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Group A: 200 mg of the test food every day after breakfast.
Interventions/Control_2
Group B: 400 mg of the test food every day after breakfast.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
1.Persons who have been fully informed of the purpose and content of this study, have the capacity to consent, and have volunteered to participate of their own free will with full understanding and have agreed in writing to participate in this study.
2.Japanese males who are between 40 and 60 years of age at the time consent is obtained and who are working full-time.
3.Those who have some problems or troubles with sleep.
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 one bedding (futon or bed, etc.) during the examination period.
10. Those who sleep less than 6 hours (calculated based on their reported normal sleeping and waking times).
11. Those who are not able to comply with the gentle sleep control (going to bed within +-2 hours and waking up within +-2 hours) during the examination 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*).
Items that cannot be listed in the Exclusion Criteria column are listed in Other Relevant Items.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Sakurai |
Organization
Clinical Creative Corporation
Division name
Pharmaceuticals Division
Zip code
354-0001
Address
4-1-37 Kamimuneoka, Shiki-shi, Saitama
TEL
090-6700-4850
s-sakurai@cli-creative.com
Public contact
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
2F 3-Minami 2-18 Hondori, Shiroishi-ku, Sapporo, Hokkaido
TEL
09031166218
Homepage URL
k-ohno@cli-creative.com
Sponsor or person
Institute
Clinical Creative Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
DELIGHTEX PTE. LTD.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Yurinokai Hospital Clinical Trial Review Committee
Address
11-186 Yurigahara, Kita-ku, Sapporo, Hokkaido
Tel
011-771-1501
info@yurinokai.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
医療法人社団 札幌百合の会病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
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 trials in the month prior to the date of consent, or planned participation during the study period.
17. Persons who have traveled abroad within 2 weeks prior to the date of consent or are planning to travel abroad during the study period.
18. Any other person who is deemed by the physician to be inappropriate to participate in this study.
Management information
Registered date
| 2024 | Year | 03 | Month | 19 | Day |
Last modified on
| 2024 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061535
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
