UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028048 |
|---|---|
| Receipt number | R000032114 |
| Scientific Title | Examination on an influence of continuous intake of a test food product on blood immune markers and a feeling of fatigue |
| Date of disclosure of the study information | 2017/09/15 |
| Last modified on | 2018/01/05 08:27:15 |
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Basic information
Public title
Examination on an influence of continuous intake of a test food product on blood immune markers and a feeling of fatigue
Acronym
Examination on an influence of continuous intake of a test food product on blood immune markers and a feeling of fatigue
Scientific Title
Examination on an influence of continuous intake of a test food product on blood immune markers and a feeling of fatigue
Scientific Title:Acronym
Examination on an influence of continuous intake of a test food product on blood immune markers and a feeling of fatigue
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An objective is to examine an influence of continuous intake of a test food product on a blood immune marker and a feeling of fatigue by selecting males and females aged 40 and over, below 60 as subjects and assigning them to take the test food product for 8 weeks on a continuous basis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
1.Number of each leukocyte subset
2.T-cell blastogenesis
3.NK activity
4.POMS2 (Short Form) Fatigue - Inertia T score
5.Brief Job Stress Questionnaire
6.Chalder fatigue scale
Key secondary outcomes
1.IgA in feces
2.OSA Sleep Inventory
3.Fecal Questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
8-week intake of the test food
Interventions/Control_2
8-week intake of the placebo 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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Age: 40 and over, below 60
2) Males and females with Japanese nationality
3) Profile of Mood States (POMS2) Short Form Fatigue - Inertia T Score: 60 and over
4) Daytime workers who are not primarily engaged in physical labor but are engaged in sales, clerical work, administrative work, etc.
5) Persons who wake up same time every morning
6) Scoring of Immunological Vigor (7 items): 10 to 18
7) Persons who are able to take 6 tablets/day for 8 weeks on the continuous basis
Key exclusion criteria
1) Currently in treatment with medication or seeing a doctor for treatment
2) A positive test result on hepatitis B
3) Allergic to food, medication, pollen, or with another type of allergic disease
4) Regular intake of medication with a possible influence on an immune function (antibiotics, immunosuppressive drugs, anti-inflammatory drugs, anti-rheumatic drugs, antihistamines, anti-allergy drugs, lactobacillus preparation, etc.)
5) Vaccinated within the past 3 months or desired to be vaccinated during a study period
6) Current habit of smoking
7) Extreme faddiness
8) Extremely irregular lifestyle including an irregular eating pattern, a irregular sleep pattern, etc.
9) Presence or previous history of a mental disorder (depression, etc.)
10) Regular intake of any one of food (mushrooms, barley, seaweeds), health food products, and supplements with high content of beta-glucan
11) High alcohol intake (alcohol intake of 60 g and over per day)
12) Engaged in active sports resulted in shortness of breath, such as jogging, marathon, or soccer.
13) Currently participating another clinical study or participation in another clinical study within the past 3 months
14) Determined by the investigator to be unsuitable for enrollment in this study
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Matsuoka Masao |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
Address
Oekkusu Bldg.10F, 5-31-19 Shiba Minato-ku, Tokyo 108-0014 Japan
TEL
81-3-3431-1260
matsuoka@huma-c.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Matsuoka Masao |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
Address
Oekkusu Bldg.10F, 5-31-19 Shiba Minato-ku, Tokyo 108-0014 Japan
TEL
81-3-3431-1260
Homepage URL
matsuoka@huma-c.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
Asahi Group Holdings,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2017 | Year | 09 | Month | 15 | 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 | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 16 | Day |
Date of closure to data entry
| 2017 | Year | 11 | Month | 18 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 04 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 03 | Day |
Last modified on
| 2018 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032114
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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