UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050852 |
|---|---|
| Receipt number | R000057949 |
| Scientific Title | A study to evaluate the effect of food ingredient in healthy adult on the Fatigue reduction function -Placebo-controlled, randomized, double-blind, parallel-group comparative method |
| Date of disclosure of the study information | 2023/04/14 |
| Last modified on | 2023/04/14 17:26:59 |
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Basic information
Public title
A study to evaluate the effect of food ingredient in healthy adult on the Fatigue reduction function -Placebo-controlled, randomized, double-blind, parallel-group comparative method
Acronym
A study to evaluate the effect of food ingredient in healthy adult on the Fatigue reduction function -Placebo-controlled, randomized, double-blind, parallel-group comparative method
Scientific Title
A study to evaluate the effect of food ingredient in healthy adult on the Fatigue reduction function -Placebo-controlled, randomized, double-blind, parallel-group comparative method
Scientific Title:Acronym
A study to evaluate the effect of food ingredient in healthy adult on the Fatigue reduction function -Placebo-controlled, randomized, double-blind, parallel-group comparative method
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, functions related to the reduction of fatigue will be evaluated using VAS with the aim of obtaining new evidence for test foods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fatigue VAS
Key secondary outcomes
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
Ingestion of test food
Interventions/Control_2
Ingestion of placebo
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 from 20 to 64 years of age
(2)Those who are aware of being easily fatigued
(3)Subjects who have received sufficient explanation of this study, understands the contents, and are able to give written consent
Key exclusion criteria
(1) Those who have, are being treated for, or have a history of serious or metabolic diseases such as diabetes mellitus
(2) Those who have chronic diseases and take drugs on a daily basis
(3) Those who regularly use immunological or fatigue medications.
(4) Those who are unable to stop consuming foods that contain a large amount of Bacillus acetate.
(5) Those who cannot stop taking foods that contain a lot of lactobacilli and bifidobacteria.
(6) Persons who deviate from proper alcohol consumption
(7) Persons who reported to have food allergies
(8) Those who are undergoing treatment that may affect the results of the study
(9) Those who work day and night shifts or engage in physical labor such as heavy lifting.
(10) Those who are engaged in physical labor such as working day and night shifts or heavy lifting.
(11) Those who have a history of digestive organ disease or digestive organ surgery.
(12)Pregnant women, women who intend to become pregnant during the study period, and breast-feeding women
(13)Any person who is judged to be inappropriate as a research subject based on the results of screening tests
(14)Persons with a history or current medical history of drug or alcohol dependence.
(15) Those who are currently participating in a research study involving the ingestion of other foods or the use of pharmaceuticals, those who have participated in other clinical research studies within one month of obtaining consent, or those who intend to participate in such studies.
(16)Those who plan to travel abroad, such as on an overseas trip, during the research period.Any other person whom the principal investigator determines to be inappropriate as a research subject.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Kiichi |
| Middle name | |
| Last name | Sugiyama |
Organization
Hokkaido University of education
Division name
College of education
Zip code
068-0835
Address
1-34-1, Midorigaoka,Iwamisawa-shi, Hokkaido, 002-8501, Japan
TEL
0126-32-0250
sugiyama.kiichi@i.hokkyodai.ac.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Oe |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
182-0002
Address
2-5-7, Sengawa-cho, Chofu-shi, Tokyo
TEL
03-5384-7759
Homepage URL
mariko_oe@kewpie.co.jp
Sponsor or person
Institute
Hokkaido University of education
Institute
Department
Personal name
Funding Source
Organization
Kewpie Corporation
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
Ethics Review Committee of Hokkaido University of Education
Address
1-34-1, Midorigaoka,Iwamisawa-shi, Hokkaido, 002-8501, Japan
Tel
0126-32-0214
iwa-somu@j.hokkyodai.ac.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
| 2023 | Year | 04 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 07 | 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
| 2023 | Year | 04 | Month | 14 | Day |
Last modified on
| 2023 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057949
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
