UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036314 |
|---|---|
| Receipt number | R000041375 |
| Scientific Title | A clinical study to evaluate to the effects of algae food on attenuating fatigue sensation. |
| Date of disclosure of the study information | 2020/03/29 |
| Last modified on | 2021/08/30 18:29:58 |
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Basic information
Public title
A clinical study to evaluate to the effects of algae food on attenuating fatigue sensation.
Acronym
A clinical study to evaluate to the effects of algae food on attenuating fatigue sensation.
Scientific Title
A clinical study to evaluate to the effects of algae food on attenuating fatigue sensation.
Scientific Title:Acronym
A clinical study to evaluate to the effects of algae food on attenuating fatigue sensation.
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of food containing algae on attenuating fatigue sensation: a randomized, double-blind, placebo-controlled, parallel-group comparative study
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS(integral fatigue sensation, physical fatigue sensation and mental fatigue sensation)
Key secondary outcomes
VAS(sleepiness, motivation and concentration), autonomic nervous function evaluation, work performance evaluation, blood analysis and urinalysis
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 the test food for 4 weeks
Interventions/Control_2
Intake of the 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 whose age of 20 years or more and less than 65 years
2) Subjects who are aware of fatigue sensation in daily life
3) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntary participate in the study and being able to personally sign a written informed consent
Key exclusion criteria
1) Subjects receiving a medical treatment for serious renal, hepatic, cardio-vascular, respiratory, endocrine or metabolic disorders or having a medical history of these disorders
2) Subjects having the chronic fatigue syndrome(CFS), or subjects deemed to have severe fatigue like idiopathic chronic fatigue by the investigator
3) Subjects who go to a doctor about chronic diseases
4) Subjects who have mental disease such as depression and schizophrenia
5) Subjects who have sleep disorders to need medical treatment
6) Subjects who have the possibility of developing allergic symptoms by the test food
7) Subjects who take regularly pharmaceuticals or quasi-drugs which having the efficacy for recovery from fatigue or nutrient replenishment in case of physical fatigue
8) Subjects who take regularly Foods with Function Claims labeled the effect of attenuating fatigue sensation
9) Subjects who drink a lot (Subjects whose pure alcohol intake per day is 60 g or more)
10) BMI<17 kg/m2 and >=30 kg/m2
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 clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study
13) Female subjects who are pregnant or lactating, or intending to become pregnant during the study
14) Subjects deemed unsuitable by the investigator
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Madoka |
| Middle name | |
| Last name | Takahashi |
Organization
Kobelco Eco-Solutions Co.,Ltd.
Division name
Water and Sludge Treatment Systems Development Department Technical Development Division
Zip code
651-2241
Address
1-4-1, Murotani, Nishi-ku, Kobe, Hyogo
TEL
078-992-6956
md.takahashi@kobelco-eco.co.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Kashiwagi |
Organization
Soiken Inc.
Division name
R&D Division
Zip code
560-0082
Address
Senri Life Science Center 13F,1-4-2,Shinsenre-higashimachi, Toyonaka,Osaka
TEL
06-6871-8888
Homepage URL
kashiawgi_shnichi@soiken.com
Sponsor or person
Institute
Soiken Inc.
Institute
Department
Personal name
Funding Source
Organization
Kobelco Eco-Solutions Co.,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
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 29 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2072-6643/12/10/3098
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2072-6643/12/10/3098
Number of participants that the trial has enrolled
66
Results
The test food intake group showed significantly lower levels of physical and mental fatigue sensations than the placebo intake group.
Results date posted
| 2021 | Year | 08 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy males and females whose age of 20 years or more and less than 65 years
Participant flow
Completed(n=63)
Analyzed(n=52)
Adverse events
No adverse events were observed that be related to test food.
Outcome measures
VAS questionnaire about fatigue sensation, autonomic nervous function evaluation, work performance evaluation, blood analysis
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 06 | 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
| 2019 | Year | 03 | Month | 27 | Day |
Last modified on
| 2021 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041375
