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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028048
Receipt No. 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

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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
Email 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
Email matsuoka@huma-c.co.jp

Sponsor
Institute HUMA R&D CORP
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032114

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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