UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041586 |
|---|---|
| Receipt number | R000043511 |
| Scientific Title | Study of the effect of the food containing plant-derived ingredient Y on sleep |
| Date of disclosure of the study information | 2020/08/28 |
| Last modified on | 2021/01/08 23:37:29 |
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Basic information
Public title
Study of the effect of the food containing plant-derived ingredient Y on sleep
Acronym
The effect of the plant-derived ingredient Y on sleep
Scientific Title
Study of the effect of the food containing plant-derived ingredient Y on sleep
Scientific Title:Acronym
The effect of the plant-derived ingredient Y on sleep
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of plant-derived ingredient Y on sleep
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the OSA questionnaire before and after the 1-week treatment period
Key secondary outcomes
Evaluation of
1) the symptoms questionnaires about sleep, fatigue, stress
2) the nocturnal awakening time and sleep efficiency assessed by actigraph
before and after the 1-week treatment period
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of active tablets (containing plant-derived ingredient X) once a day for 1 week;
Washout (2 weeks);
Intake of placebo tablets (not containing plant-derived ingredient X) once a day for 1 week
Interventions/Control_2
Intake of placebo tablets (not containing plant-derived ingredient X) once a day for 1 week;
Washout (2 weeks);
Intake of active tablets (containing plant-derived ingredient X) once a day for 1 week
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
| 30 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Adults aged from 30 to 49, or 60 to 69
2) Healthy subjects with no serious disorders
3) Subjects who have dissatisfaction with sleep
Key exclusion criteria
1) Having history or presence of serious disorders
2) Presence of disorders about sleep
3) Taking hypnotics or psychotropic drug
4) Planned to who take a health food about sleep or stress
5) Pregnancies and lactations
6) Heavy alcohol drinker (over 60g per day)
7) Habitually taking much coffee (over five cups per day)
8) Food allergy, drug allergy, metal allergy, or any allergy
9) Feeling discomfort while sleeping with wearing activity monitor attached
10) Subjects who herself and/or her family members are working for an advertising agency, investigation and consultant business, and a mass media-related company, the food company, the cosmetics company, the toiletry company, and company in manufacturing and distribution
11) Planned to participate in other clinical study during current study
12) Determined to be unqualified by the physician in charge or the responsible person of the study
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Misawa |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan
TEL
+81-3-5630-7268
misawa.koichi@kao.com
Public contact
Name of contact person
| 1st name | Chika |
| Middle name | |
| Last name | Suzukamo |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan
TEL
+81-3-5630-7266
Homepage URL
suzukamo.chika@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
None
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
Ueno-Asagao Clinic Ethical Review Committee
Address
Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015, Japan
Tel
+81-3-6240-1162
jimukyoku@tes-h.co.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
うえのあさがおクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 28 | Day |
Related information
URL releasing protocol
Unpublished due to the protocol including the intellectual property rights
Publication of results
Unpublished
Result
URL related to results and publications
works in progress
Number of participants that the trial has enrolled
71
Results
A significant difference of the primary outcome was observed in healthy adults in their 60s.
Results date posted
| 2021 | Year | 01 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy adults
Participant flow
70 participants completed and 68 subjects were incorporated into the analyses
Adverse events
No adverse effect reported
Outcome measures
Sleep quality
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 06 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 19 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 28 | Day |
Date analysis concluded
| 2020 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 28 | Day |
Last modified on
| 2021 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043511
