UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045634 |
|---|---|
| Receipt number | R000051430 |
| Scientific Title | A study to evaluate the effects of plant extract material on fatigue sensation and sleep |
| Date of disclosure of the study information | 2021/10/02 |
| Last modified on | 2022/04/04 13:10:11 |
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Basic information
Public title
A study to evaluate the effects of plant extract material on fatigue sensation and sleep
Acronym
A study to evaluate the effects of plant extract material on fatigue sensation and sleep
Scientific Title
A study to evaluate the effects of plant extract material on fatigue sensation and sleep
Scientific Title:Acronym
A study to evaluate the effects of plant extract material on fatigue sensation and sleep
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of test food for 4 weeks on fatigue sensation and sleep
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS(fatigue sensation)
Key secondary outcomes
Chalder fatigue scale, POMS2 Japanese Adult Short version, OSA sleep inventory MA version, St. Mary's Hospital sleep questionnaire, autonomic nervous function evaluation, blood test, immunity evaluation, questionnaire on defecation, body weight, waist circumference, BMI
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
Intake of test food for 4 weeks
Interventions/Control_2
Intake of placebo for 4 weeks
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy males and females aged 20- 65 years
2) Subjects who perceive fatigue sensation in daily life
3) Subject whose BMI is 23.0 kg/m2 or more and less than 30.0 kg/m2
4) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
Key exclusion criteria
1) Subjects with serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders
2) Subjects with chronic fatigue syndrome (CFS) , or subjects deemed to have severe fatigue such as idiopathic chronic fatigue by the investigator
3) Subjects receiving a medical treatment for sleep disorders
4) Subjects who take regularly pharmaceuticals or quasi-drugs which having the efficacy for recovery from fatigue or nutritional supplements during physical fatigue
5) Subjects who take regularly Foods with Function Claims labeled the effect of attenuating fatigue sensation
6) Subjects who take pharmaceuticals or quasi-drugs which having the efficacy for improving sleep quality
7) Subjects who take Foods with Function Claims labeled the effect of improving sleep quality
8) Subjects whose lifestyles are irregular because of night shift or others
9) Subjects who have the possibility of developing allergic symptoms by the test food
10) Female subjects who are pregnant or lactating, or intending to become pregnant during the study
11) Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood)
12) Subjects who took part in another study within 3 months prior to the start of the present study or who is currently taking part in another study
13) Subjects deemed unsuitable by the investigator
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Inamasu |
Organization
Kracie Holdings, Ltd.
Division name
R&D Innovation Group
Zip code
108-8080
Address
3-20-20, Kaigan, Minato-ku, Tokyo
TEL
070-3350-0767
s.inamasu@kracie.co.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Watanabe |
Organization
Soiken Inc.
Division name
R&D Division
Zip code
560-0082
Address
Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka-shi, Osaka
TEL
06-6871-8888
Homepage URL
watanabe_kota@soiken.com
Sponsor or person
Institute
Soiken Inc.
Institute
Department
Personal name
Funding Source
Organization
Kracie Holdings, 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
IRB of Fukuda Clinic
Address
Shin-Osaka brick building 2F, 1-6- 1 Miyahara, Yodogawa-ku, Osaka-shi, Osaka
Tel
06-6398-0203
fukudaclinicIRB@gmail.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
医療法人弘正会ふくだ内科クリニック（大阪府）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 02 | 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
| 2021 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 01 | Day |
Last modified on
| 2022 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051430
