UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051564 |
|---|---|
| Receipt number | R000058510 |
| Scientific Title | Verification of impacts on sleep quality by test-food intakes |
| Date of disclosure of the study information | 2024/07/14 |
| Last modified on | 2024/04/23 18:09:44 |
* 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
Verification of impacts on sleep quality by test-food intakes
Acronym
Verification of impacts on sleep quality by test-food intakes
Scientific Title
Verification of impacts on sleep quality by test-food intakes
Scientific Title:Acronym
Verification of impacts on sleep quality by test-food intakes
Region
| Japan |
Condition
Condition
Healthy male/female subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to verify some kind of effect on sleep quality by test-food intakes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep qualities (subjective sleep-assessment questionnaire, EEG measurement)
Key secondary outcomes
1. Visual Analogue Scale (fatigue feeling)
2. Visual Analogue Scale (stress)
3. Occupational stress questionnaire (abridged edition, 57 items, B-item only)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of the test foods, five tablets a day.
Interventions/Control_2
Ingestion of the placebo foods, five tablets a day.
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Male/female subjects ranging in age from 20 to 59 at informed consent.
(2) Subjects with unsatisfactory sleep qualities (e.g., falling asleep, sleep, waking up).
(3) Subjects working in the office continuously for five days a week.
(4) Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria
Subjects - -
(1) taking in affecting foods (e.g., GABA), not less than once a week,
(2) who will take medicines which might affect the test (e.g., sleep aid drug) during the test period,
(3) who have been on antibiotics within the last 2 months before this study,
(4) being under pharmacotherapy, diet remedy or ergotherapy,
(5) with previous medical history of mental disorder,
(6) with chronic fatigue syndrome, sleep disorder, sleep-apnea syndrome, prostate enlargement, overactive cystitis,
(7) with night urinations, not less than twice a day,
(8) engaging a physical labor,
(9) with extremely irregular life rhythm,
(10) with irregular bedtime and waking up,
(11) having an irregular work,
(12) with affecting rhinitis or pollinosis,
(13) with over 30.0 kg/m2 of BMI,
(14) with excessive alcohol intake,
(15) having a habit of smoking,
(16) with difficulty to stop drinking during the EEG measurement period or who are aware of stress caused by stop drinking,
(17) planning to go on a business/long/event trip during the EEG measuring period,
(18) who might be woken up by a roomer during sleep,
(19) being under another clinical test (medicine or health food), or participated in that within the last 4 weeks, or will join that after the consent,
(20) with pregnancy, possibly one, or lactating,
(21) with medical history of serious diseases (e.g., cardiac),
(22) who break out in a rash from putting electrodes on the head and neck,
(23) with a pacemaker,
(24) with drug/food allergy,
(25) who donated their blood components or blood (0.2 L) within the last month,
(26) who donated his blood (0.4 L) within the last 3 months,
(27) who donated her blood (0.4 L) within the last 4 months,
(28) being collected in total of his blood (1.2 L) within the last 12 months and in this study,
(29) being collected in total of her blood (0.8 L) within the last 12 months and in this study,
(30) being determined as ineligible for participation by the principal/sub investigator - - .
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Asahi Quality & Innovations, Ltd.
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 14 | 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
Completed
Date of protocol fixation
| 2023 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 10 | Day |
Last modified on
| 2024 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058510
