UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045191 |
|---|---|
| Receipt number | R000051626 |
| Scientific Title | Anti-fatigue effect by ingesting enzyme supplements derived from 65 kinds of plants and 12 kinds of lactic acid bacteria: a randomized, double blind, placebo-controlled study |
| Date of disclosure of the study information | 2021/08/23 |
| Last modified on | 2023/02/17 13:51:03 |
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Basic information
Public title
Anti-fatigue effect by ingesting enzyme supplements derived from 65 kinds of plants and 12 kinds of lactic acid bacteria
Acronym
OM-X anti-fatigue study
Scientific Title
Anti-fatigue effect by ingesting enzyme supplements derived from 65 kinds of plants and 12 kinds of lactic acid bacteria: a randomized, double blind, placebo-controlled study
Scientific Title:Acronym
Anti-fatigue effect by ingesting enzyme supplements derived from 65 kinds of plants and 12 kinds of lactic acid bacteria
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of anti-fatigue effect by ingestion of test article
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS, Chalder fatigue scale
Key secondary outcomes
blood test
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Take the test article for 12 weeks
Interventions/Control_2
Take the placebo for 12 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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects who often feel tired, those who feel more tired than before
Key exclusion criteria
1.Subjects with food allergies
2.Pregnant women, lactating women, and those who are planning to become pregnant during the test period
3.Subjects who are currently going to the hospital or receiving a doctor's prescription due to chronic illness
4.Subjects who have a serious illness
5.Subjects who are receiving hormone replacement therapy
6.Subjects who have been diagnosed with chronic fatigue (chronic fatigue syndrome)
7.Subjects who are taking supplements / medicines that affect the effect of the test product
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Masatomo |
| Middle name | |
| Last name | Najima |
Organization
Japan Clinical Trial Association
Division name
N.A.
Zip code
1600022
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
info@yakujihou.org
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kaneko |
Organization
Japan Clinical Trial Association
Division name
N.A.
Zip code
1600022
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
Homepage URL
info@yakujihou.org
Sponsor or person
Institute
Japan Clinical Trial Association
Institute
Department
Personal name
Funding Source
Organization
BIOBANK 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 Pharmaceutical Law Wisdoms
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
Tel
0364574911
master@yakujihou.net
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
| 2021 | Year | 08 | Month | 23 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S1756464622002985
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S1756464622002985
Number of participants that the trial has enrolled
38
Results
Fatigue was measured by VAS and Czalder Fatigue Scale (CFS), and overall antioxidant capacity was measured by d-ROM and BAP. We also evaluated food safety. As a result, in VAS and CFS he detected a significant difference between the two groups. No safety issues occurred. It was found that the intake of OM-X improved fatigue in healthy people with transient fatigue. In addition, there were no adverse effects from ingestion of food.
Results date posted
| 2023 | Year | 02 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A group: n=20 ( M:10, F:10 )
B group: n=20 ( M:10, F:10 )
Participant flow
According to inclusion/ exclusion criteria, 40 subjects were selected and sequentially allocated to two groups by 20 each using a random number table. Among those, 2 of the Group A declined to participate in the study, and remained 38 subjects launched allocated intervention. In the process of assignment by the person in charge, background factors such as gender and age were taken into consideration to avoid biased distribution. The allocation list was sealed and strictly controlled until the end of the study. Subjects in Group A received the test sample (Active) and subjects in the Group B received Placebo.
Adverse events
none
Outcome measures
the primary outcome
VAS (Visual analog scale),
Chalder fatigue scale (CFS)
the secondary outcomes
d-ROMs test by blood
BAP test by blood
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 15 | 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 | 08 | Month | 18 | Day |
Last modified on
| 2023 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051626
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