UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000046407 |
|---|---|
| Receipt number | R000052952 |
| Scientific Title | An exploratory study on the effects of continuous intake of beta-glucan-rich barley on human immune function and others |
| Date of disclosure of the study information | 2023/12/31 |
| Last modified on | 2024/04/12 11:57:40 |
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Basic information
Public title
An exploratory study on the effects of continuous intake of beta-glucan-rich barley on human immune function and others
Acronym
An exploratory study on the effects of continuous intake of barley on human immune function and others
Scientific Title
An exploratory study on the effects of continuous intake of beta-glucan-rich barley on human immune function and others
Scientific Title:Acronym
An exploratory study on the effects of continuous intake of barley on human immune function and others
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratory investigate the effects of continuous intake of beta-glucan-rich barley on human immune function and others
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Expression levels of anti-viral genes of peripheral blood mononuclear cells stimulated by viruses
Key secondary outcomes
1) Levels of IgA and short chain fatty acids in feces
2) Profile of Mood States-Brief Form Japanese Version
3) Dietray habit
4) Physical activity
5) Record of daily physical condition, body temperature, defecation status
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
100 g/day of boiled barley intake for 4 weeks
Interventions/Control_2
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) Aged 20 years or older
2) BMI not less than 18.5 kg/m2, under 25.0 kg/m2
3) Those who do not have any disease receiving continuous treatment, medication, and lifestyle guidance
4) Those who are habitually eating white rice as staple food once or more daily
Key exclusion criteria
1) Women who are pregnant or may become pregnant, or lactating
2) Those who areparticipating or plannning to participate in other clinical trials during the current study
3) Those who may be allergic to the test meal
4) Those who are considered as inappropriate candidates by the principal investigator
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Masuko |
| Middle name | |
| Last name | Kobori |
Organization
National Agriculture and Food Research Organization
Division name
Institute of Food Research
Zip code
3058642
Address
2-1-12 Kannondai, Tsukuba, Ibaraki 305-8642, Japan
TEL
029-838-7971
kobori@affrc.go.jp
Public contact
Name of contact person
| 1st name | Risa |
| Middle name | |
| Last name | Araki |
Organization
National Agriculture and Food Research Organization
Division name
Institute of Food Research
Zip code
3058642
Address
2-1-12 Kannondai, Tsukuba, Ibaraki 305-8642, Japan
TEL
029-838-7971
Homepage URL
arakir778@affrc.go.jp
Sponsor or person
Institute
National Agriculture and Food Research Organization, Institute of Food Research
Institute
Department
Personal name
Funding Source
Organization
Ministry of Agriculture, Forestry and Fisheries
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board for Human Subjects Research
Address
3-1-1 Kannondai, Tsukuba, Ibaraki 305-8642, Japan
Tel
029-838-6932
naro-human-jikken@ml.affrc.go.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
国立研究開発法人農業・食品産業技術総合研究機構 食品研究部門（茨城県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 31 | 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
| 2021 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 05 | 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
| 2021 | Year | 12 | Month | 17 | Day |
Last modified on
| 2024 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052952
| Research Plan | |
|---|---|
| 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 |
