UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055400 |
|---|---|
| Receipt number | R000063281 |
| Scientific Title | Efficacy of plant extracts on sleep quality |
| Date of disclosure of the study information | 2024/09/14 |
| Last modified on | 2026/01/06 11:11:43 |
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Basic information
Public title
Efficacy of plant extracts on sleep quality
Acronym
Efficacy of plant extracts on sleep quality
Scientific Title
Efficacy of plant extracts on sleep quality
Scientific Title:Acronym
Efficacy of plant extracts on sleep quality
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of plant extracts on sleep quality
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Visual analogue scale (VAS) for fatigue, when waking up.
Key secondary outcomes
VAS for sleep quality
VAS for fatigue
OSA sleep inventory
Fatigue scale
POMS2
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
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of plant extract for 12 days
Interventions/Control_2
Ingestion of placebo for 12 days
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
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
1.Healthy men aged 40-65
2. Regular health checkup recipients
3.Day shift worker
4.Feeling fatigue for weekend
5.Feeling sleepiness in daytime
Key exclusion criteria
1.Patient
2.BMI>28kg/m2
3.Hypertension
4.Inaccurate evaluation of VSA
5.Alcohol abuse
6.Short sleeper
7.Use of sleep medication
8.Irregular sleep patterns
9.Participants of other clinical trials
10.Food allergy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kanaya |
Organization
Yamazaki Otolaryngology Clinic
Division name
chief director
Zip code
060-0011
Address
1-16,kita 11-jo,nishi 14-chome,chuo-ku,Sapporo-shi,Hokkaido
TEL
+81-11-757-3387
y-kohzai@kyowa-t.com
Public contact
Name of contact person
| 1st name | Isao |
| Middle name | |
| Last name | Takehara |
Organization
Kyowa trial Corporation
Division name
Clinical research department.
Zip code
060-0011
Address
1-16,kita 11-jo,nishi 14-chome,chuo-ku,Sapporo-shi,Hokkaido
TEL
+81-11-200-9431
Homepage URL
i-takehara@kyowa-t.com
Sponsor or person
Institute
Kyowa trial Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.com
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.shinryo-to-shinyaku.com/db/pdf/sin_0062_07_0443.pdf
Number of participants that the trial has enrolled
58
Results
METHODS: A crossover RCT was conducted in 58 healthy Japanese men. Participants consumed either a test coffee chlorogenic acids (116.9 mg/d) or a placebo for 12-day with a 1- to 2-week washout periods. The primary outcome was a VAS for fatigue. RESULTS: 57 completed the study and were included in FAS. The LS mean difference in VAS for fatigue between the coffee chlorogenic acids and placebo was -7.4 mm (95% CI: -13.1 to -1.7, p = 0.012) at week 1, and -2.0 mm (95% CI: -8.7 to 4.7, p = 0.551) in week 2.
Results date posted
| 2025 | Year | 07 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy Japanese men with daytime work schedules.
Participant flow
Assessed for eligibility (n = 131)
Screening (n = 101)
Randomized (n = 58)
Intervention (n=57)
Analysis (n=57)
Adverse events
No adverse events were reported.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2024 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 03 | Day |
Last modified on
| 2026 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063281
