UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049817 |
|---|---|
| Receipt number | R000056726 |
| Scientific Title | A randomized, parallel-group comparison study o on the effects of continuous intake of barley on human immune function and others |
| Date of disclosure of the study information | 2024/12/31 |
| Last modified on | 2024/04/12 11:59:42 |
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Basic information
Public title
A randomized, parallel-group comparison study on the effects of continuous intake of barley on human immune function and others
Acronym
A study on the effects of continuous intake of barley on human immune function and others
Scientific Title
A randomized, parallel-group comparison study o on the effects of continuous intake of barley on human immune function and others
Scientific Title:Acronym
A 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 |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of continuous intake of barley on human immune function and others
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Questionnaire for physical condition and stress
Key secondary outcomes
1.Expression levels of CD86 and others in conventional DC,plasmacytoid DC, and monocyte
2.NK cell activity
3.White blood cell count
4.Levels of IgA in feces
5.Levels of short chain fatty acids in feces
6.Intestinal flora
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) 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
100 g/day of boiled barley intake for 8 weeks
Interventions/Control_2
100 g/day of cooked white rice intake for 8 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Japanese men and women aged 20 years or older at the time of registration.
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 usually consume cooked white rice as a staple food at least once a day (Priority given to registrate those who consume at least 100 g/meal of cooked white rice).
5.Those who can input their own data into the electronic diary.
6.Those who do not plan to be vaccinated against COVID-19 during the research period.
7.Those who received sufficient explanation for the objective and summary of the trial, and voluntarily volunteered to the trial with the agreement of informed consent.
Key exclusion criteria
1.Those who are receiving any types of medicines and/or Chinese medical treatment except a dose of medicine taken only once.
2.Those who have medical treatments such a diet therapy and/or an exercise therapy.
3.Those who had been experiencing a severe disease.
4.Those who currently have or have history of allergic dermatitis, allergic rhinitis (including seasonal hay fever), bronchial asthma, and chronic bronchitis.
5.Those who have a drug/food allergy.
6.Those who have currently been taking commercially available drugs, quasi-drug products, and foods or supplements with functional claims. However, those who can discontinue taking these foods during the trial period after obtaining informed consent will be allowed to join the trial.
7.Those who have currently been taking rice other than white rice (e.g. brown rice, barley rice, mixed grain rice) as a staple food.
8.Those who have currently been taking barley products.
9.Those who drink more than 60 g alcohol/day.
10.Those who have excessive smoking habits (21 or more cigarettes/day).
11.Those who frequently have to redo of blood for medical examinations, and who have felt unwell due to blood collection in the past.
12.Those who have donated blood of 200 mL or more by blood component donation or whole blood donation within 1 month before the beginning of the study.
13.Those who work on the shiftwork.
14.Those who have plans of major change on their lifestyle (e.g. diet, sleep and exercise) during the study period.
15.Those who are planning to travel abroad during the study period.
16.Those who have joined other clinical trials in the past 1 month before receiving informed consent in this study, or are currently joining other clinical trials, or are planning to join other clinical trials.
17.Women who are pregnant or may become pregnant, or lactating.
18.Those who are unsuitable for this trial that judged by the principal investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Risa |
| Middle name | |
| Last name | Araki |
Organization
National Agriculture and Food Research Organization
Division name
Institute of Food Research
Zip code
305-8642
Address
2-1-12 Kannondai, Tsukuba, Ibaraki, Japan
TEL
029-838-7970
arakir778@affrc.go.jp
Public contact
Name of contact person
| 1st name | Masuko |
| Middle name | |
| Last name | Kobori |
Organization
National Agriculture and Food Research Organization
Division name
Institute of Food Research
Zip code
305-8642
Address
2-1-12 Kannondai, Tsukuba, Ibaraki, Japan
TEL
029-838-7970
Homepage URL
kobori@affrc.go.jp
Sponsor or person
Institute
National Agriculture and Food Research Organization
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
Faculty of Medicine, University of Tsukuba
Name of secondary funder(s)
National Agriculture and Food Research Organization
IRB Contact (For public release)
Organization
Institutional Review Board for Human Subjects Research
Address
3-1-1 Kannondai, Tsukuba, Ibaraki, 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
Other administrative information
Date of disclosure of the study information
| 2024 | 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
| 2022 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 19 | Day |
Last modified on
| 2024 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056726
