UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037840 |
|---|---|
| Receipt number | R000043129 |
| Scientific Title | Effect of the test food on sleep and fatigue - A randomized, double blinded, parallel group comparison study - |
| Date of disclosure of the study information | 2019/08/31 |
| Last modified on | 2020/02/27 09:41:11 |
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Basic information
Public title
Effect of the test food on sleep and fatigue - A randomized, double blinded, parallel group comparison study -
Acronym
Effect of the test food on sleep and fatigue
Scientific Title
Effect of the test food on sleep and fatigue - A randomized, double blinded, parallel group comparison study -
Scientific Title:Acronym
Effect of the test food on sleep and fatigue
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of the test food on sleep and fatigue after 4 weeks of ingestion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
OSA-MA, fatigue VAS scores
Key secondary outcomes
AIS, PSQI-j, JESS, SMH, POMS2-AS scores, serum DHEA-S, serum cortisol, the ratio of serum DHEA-S and serum cortisol
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food 1 and placebo 1 for 4 weeks.
Interventions/Control_2
Intake of test food 2 and placebo 2 for 4 weeks.
Interventions/Control_3
Intake of test food 3 and placebo 2 for 4 weeks.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Participant who works on the week days (Monday through Friday).
2.Participant who has regular working days and non- working days (one must have at least 2 consecutive non-working days).
3.Participant whose T score of the Fatigue-Inertia for POMS2 is above 49, and T score of the Vigor-Activity for POMS2 is less than 51 at the pre-test.
4.Participant whose score for Athens Insomnia Scale is above 5.
Key exclusion criteria
1.Subject who is under medication treatment, dietetic therapy, or exercise therapy
2.Subject who is under sleep, stress, and/or fatigue treatment
3.Subject who has or has a history of diabetes, liver disease, kidney disease, heart disease, having troubles in adrenocortical hormone secretion, or other metabolic disease
4.Subject who has history of mental illness, chronic fatigue syndrome or sleep disturbance
5.Subject who has been diagnosed as or who is suspected as sleep apnea syndrome
6.Subject who is taking regular medication, or who has or had a history of serious disease that requires regular medication
7.Subject who is regularly taking medication, quasi-medicine, health food or food with functional claims that affect the test results
8.Subject who is a day shift worker or is involved in manual labor such as heavy object transportation
9.Subject whose working days and non-working days are irregular
10.Subject who is planning to work on more than 2 night shifts during the study period
11.Subject who showed abnormal clinical test results or cardiopulmonary function and has been decided as an inappropriate candidate for the present study
12.Subject who has an allergy for the test food
13.Subject who is currently pregnant or planning to get pregnant and breast feed the baby during the study period
14.Subject who has participated in other clinical studies within the last one months
15.Subject who cannot follow the regulations of the current study and cannot carry out the specified questionnaires
16.Subject who is decided as an inappropriate candidate according to the life style habit questionnaire
17.Subject who showed abnormal physical examination value and other clinical test values
18.Subject who is planning to go abroad during the study period, or is planning to go for a domestic travel for more than 7 consecutive days
19.Subject who is considered as an inappropriate candidate by the doctor in charge or the lead principal investigator
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Yui |
Organization
FANCL Corporation
Division name
Research Institute, Health science research center
Zip code
244-0806
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3755
ke-yui@fancl.co.jp
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Shimada |
Organization
TTC Co., Ltd.
Division name
Clinical Research Planning Department
Zip code
150-0021
Address
1-20-2, Ebisu-nishi, Shibuya-ku, Tokyo, Japan
TEL
03-5459-5329
Homepage URL
h.shimada@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aisei Hospital Ueno Clinic Research Ethics Committee
Address
2-18-6, Higashiueno, Taitou-ku, Tokyo
Tel
03-6455-0880
t.saito@ttc-smo.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
公益財団法人愛世会 愛誠病院 上野クリニック
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 31 | 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
| 2019 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 29 | Day |
Last modified on
| 2020 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043129
