UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030886 |
|---|---|
| Receipt number | R000035268 |
| Scientific Title | Examination on an effect of continuous intake of a test food product on relieving a feeling of fatigue |
| Date of disclosure of the study information | 2018/01/23 |
| Last modified on | 2018/07/11 13:54:46 |
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Basic information
Public title
Examination on an effect of continuous intake of a test food product on relieving a feeling of fatigue
Acronym
Examination on an effect of continuous intake of a test food product on relieving a feeling of fatigue
Scientific Title
Examination on an effect of continuous intake of a test food product on relieving a feeling of fatigue
Scientific Title:Acronym
Examination on an effect of continuous intake of a test food product on relieving a feeling of fatigue
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine an effect of a test food product on reliving a feeling of fatigue after an exercise stress test by selecting those who are aged 30 and over, below 45 and have no exercise habit and assigning them to take the test food product for 1 week on a continuous basis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Creatine kinase,VAS
Key secondary outcomes
Hematologic test, blood biochemical test, vital signs
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
1-week intake of the test food
Wash out
1-week intake of the placebo
Interventions/Control_2
1-week intake of the placebo
Wash out
1-week intake of the test food
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
| 30 | years-old | <= |
Age-upper limit
| 45 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Age: 30 and over, below 45
2)Sex: Males and females with Japanese nationality
3)No exercise habit in the last 12 months
*Those who exercise once a week or less, or 2 to 3 times a month will be accepted.
Key exclusion criteria
1)Currently in treatment with medication or seeing a doctor for treatment
2)Previous history of hepatic disorder or severe disorder related to kidney, endocrine, cardiovascular system, gastro-intestine, lung, blood, or metabolism, or currently presence of complications
3)Previous history of drug allergy or food allergy
4)Regular intake of a food product or a supplement with a possible effect on relieving fatigue
5)Regular intake of medication with a possible effect on relieving fatigue
6)Extreme faddiness
7)Extremely irregular lifestyle such as a dietary pattern and a sleeping pattern
8)Suspicion of insomnia
9)Presence or previous history of mental disorder (depression, etc.)
10)Presence or previous history of alcoholism
11)Current participation in another clinical trial or participation in another clinical trial within the last three months
12)Irregular work hours such as working on night shift
13)Exercise habit (twice a week or more)
14)Determined by the investigator to be unsuitable for enrollment in this study
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takihara Takanobu |
Organization
ITO EN, Ltd.
Division name
Central Research Institute
Zip code
Address
21 Mekami, Makinohara-shi, Shizuoka 421-0516, Japan
TEL
0548-54-1247
t-takihara@itoen.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ochitani Daisuke |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
Address
Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
81-3-3431-1260
Homepage URL
ochitani@huma-c.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
ITO EN, 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
Address
Tel
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
| 2018 | Year | 01 | Month | 23 | 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
| 2017 | Year | 12 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 19 | Day |
Last modified on
| 2018 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035268
