UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036296 |
|---|---|
| Receipt number | R000041351 |
| Scientific Title | A study about feeling of fatigue reduction effect of food containing algae |
| Date of disclosure of the study information | 2020/03/29 |
| Last modified on | 2021/08/24 23:45:58 |
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Basic information
Public title
A study about feeling of fatigue reduction effect of food containing algae
Acronym
A study about feeling of fatigue reduction effect of food containing algae
Scientific Title
A study about feeling of fatigue reduction effect of food containing algae
Scientific Title:Acronym
A study about feeling of fatigue reduction effect of food containing algae
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to confirm feeling of fatigue reduction effect for four weeks continuous consumption of test food by comparison with control food.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS questionnaire about feeling of fatigue (whole body feeling of fatigue, physical feeling of fatigue and psychological feeling of fatigue )
Key secondary outcomes
*Profile of Mood States 2nd Edition
*The incidence of side effects and/or adverse events
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 test food once a day at dinner time for 4 weeks.
Interventions/Control_2
Intake control food once a day at dinner time 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 to 64 years old when consent acquisition.
2) Subjects who feel fatigue on daily basis.
3) Subjects who have received enough explanation about this study and were able to understand that, then giving written informed consent.
Key exclusion criteria
1) Subjects who have previous and/or current medical history of serious disease (e.g., heart function, blood vessel, liver function, kidney function, pulmonary function, endocrine function, function of digestive organ and/or metabolism).
2) Subjects who have been diagnosed chronic fatigue syndrome, or subjects who are decided having severe fatigue such as idiopathic chronic fatigue by investigator and/or sub-investigator.
3) Subjects who are visiting hospital due to chronic disease.
4) Subjects who have psychiatric disease such as depression and/or schizophrenia.
5) Subjects who have impairment of sleep which need medical treatment.
6) Subjects who are likely to cause allergies against test food especially algae and/or seaweeds.
7) Subjects who constantly use oral medicines and/or quasi-drug having the effect of recovering from fatigue or the effect of supplementation when physical fatigue.
8) Subjects who constantly use food with functional claim about feeling of fatigue.
9) Subjects who excessive alcohol intake.
10) Subjects their BMI is less than 17 kg/m2 or equal and more than 30 kg/m2.
11) Subjects who are participating the other clinical tests. Subjects who participated within three month prior to the current study and/or who plan to participate the other clinical tests.
12) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study.
13) Males who donated over 400mL blood and/or blood components within the last three month to the current study.
14) Females who donated over 400mL blood and/or blood components within the last four month to the current study.
15) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period.
16) Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Suguru |
| Middle name | |
| Last name | Fujiwara |
Organization
CPCC Company Limited
Division name
Division of Clinical Research
Zip code
101-0047
Address
4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Planning & Sales Department
Zip code
101-0047
Address
4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Chushin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
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
| 2020 | Year | 03 | Month | 29 | Day |
Related information
URL releasing protocol
http://www.pieronline.jp/content/article/0386-3603/47110/1851
Publication of results
Published
Result
URL related to results and publications
http://www.pieronline.jp/content/article/0386-3603/47110/1851
Number of participants that the trial has enrolled
200
Results
A significant reduction in feeling of physical fatigue was confirmed in the test food intake group.
Results date posted
| 2021 | Year | 08 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy males and females aged 20 to 64 years old
Participant flow
Completed (n=200)
Analysed (n=197)
Adverse events
No adverse events were observed that be related to test food.
Outcome measures
VAS questionnaire about feeling of fatigue
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 08 | 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
| 2019 | Year | 03 | Month | 26 | Day |
Last modified on
| 2021 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041351
