UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050072 |
|---|---|
| Receipt number | R000057043 |
| Scientific Title | Effect evaluation test on intestinal microflora by barley tea drinking in persons with allergic symptoms |
| Date of disclosure of the study information | 2023/01/18 |
| Last modified on | 2023/07/19 11:43:08 |
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Basic information
Public title
Effect evaluation test on intestinal microflora by barley tea drinking in persons with allergic symptoms
Acronym
Effect evaluation test on intestinal microflora by barley tea drinking in persons with allergic symptoms
Scientific Title
Effect evaluation test on intestinal microflora by barley tea drinking in persons with allergic symptoms
Scientific Title:Acronym
Effect evaluation test on intestinal microflora by barley tea drinking in persons with allergic symptoms
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploratory evaluate the effects of barley tea on the intestinal microbiota when continuously consumed by adults for 12 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stool test (intestinal flora, organic acids, spoilage products, and IgA)
Saliva test (saliva s-IgA)
Blood test (non-specific IgE, IgG, IgM, IgA, MAST 36)
Measure at before and 12 weeks after ingestion.
Key secondary outcomes
Fasting blood index (total protein, albumin, total cholesterol, LDL cholesterol, HDL cholesterol, neutral fat, urea nitrogen, creatinine, uric acid, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-GTP) , bumin/globulin ratio (A/G ratio), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), leucine aminopeptidase (LAP), cholinesterase (CHE), creatinine phosphokinase (CPK), HbA1C, glucose, sodium , potassium, chlorine, calcium, magnesium, inorganic phosphorus, serum iron, blood count, ferritin)
Body composition (body weight, BMI, lean body mass)
Measure at before and 12 weeks after ingestion.
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
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingest 600 ml barley tea daily for 12 weeks.
Interventions/Control_2
Ingest 500 ml water daily for 12weeks.
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.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2.Healthy Japanese who are 20 years old or more and under 65 years old
Key exclusion criteria
1.Persons who are currently suffering from some kind of disease and are judged by the investigator to need treatment
2.Persons with severe anemia
3.Pregnant, lactating, pregnant
4.Persons who may cause allergic symptoms to the ingredients contained in the test food
5.Persons with alcoholism or other mental disorders
6.Persons who have a smoking habit
7.Persons with borderline diabetes or already diagnosed with diabetes
8.Persons who may change their lifestyle during the examination period (night shift, long trip, etc.)
9.Persons who plan to take new health foods or supplement foods during the examination period
10.Persons who have received hormone replacement therapy within the past 6 months
11.Persons who have been treated with hospitalization within the past 6 months
12.Persons who participate in other clinical studies or participated in the last 3 months or plan to participate in other clinical studies.
13.Persons who are judged by the investigator to be inappropriate for this study.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Mitsuko |
| Middle name | |
| Last name | Ito |
Organization
Akasaka Family Clinic
Division name
Clinic Director
Zip code
107-0052
Address
Akasaka Plaza Bld. 3F, 15-15 Akasaka, Minato-ku, Tokyo, JAPAN
TEL
03-5562-8825
info@afc.tokyo
Public contact
Name of contact person
| 1st name | Takamasa |
| Middle name | |
| Last name | Masuda |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
0368092722
Homepage URL
masudat@hc-sys.jp
Sponsor or person
Institute
Akasaka Family Clinic
Institute
Department
Personal name
Funding Source
Organization
Ako Kasei Co., 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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, JAPAN
Tel
052-734-8885
soumu@hc-sys.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
| 2023 | Year | 01 | Month | 18 | 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
24
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
| 2023 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 18 | Day |
Last modified on
| 2023 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057043
| Research Plan | |
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| 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 |
