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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000038168 |
Receipt No. | R000043507 |
Scientific Title | A verification test of inhibition effect for acute upper respiratory tract inflammation by consumption of test food |
Date of disclosure of the study information | 2020/10/03 |
Last modified on | 2020/10/09 |
Basic information | ||
Public title | A verification test of inhibition effect for acute upper respiratory tract inflammation by consumption of test food | |
Acronym | A verification test of inhibition effect for acute upper respiratory tract inflammation by consumption of test food | |
Scientific Title | A verification test of inhibition effect for acute upper respiratory tract inflammation by consumption of test food | |
Scientific Title:Acronym | A verification test of inhibition effect for acute upper respiratory tract inflammation by consumption of test food | |
Region |
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Condition | |||
Condition | Acute upper respiratory tract inflammation | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To verify the inhibition effect for acute upper respiratory tract inflammation by consumption of test food for 12 continuous weeks. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | *Incidence of upper respiratory tract inflammation during test period
*Incidence of influenza infection during test period *Number of onset of upper respiratory tract inflammation during test period *Duration of each upper respiratory tract inflammation during test period *Days from the start of the study to the onset of upper respiratory tract inflammation and influenza |
Key secondary outcomes | *Change of sIgA concentration in salivary
*Change of NK-cell activity *WURSS-21 Japanese version *Incidence of adverse event and side effect *Body weight *BMI *Physiological tests *Hematological tests *Blood biochemical tests *Urine tests *Feces tests (short chain fatty acid, intestinal microbiota) |
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 |
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Interventions/Control_1 | One test food is extracted by 150mL of hot water. Intake the test food extract 3 times a day for 12 weeks. | |
Interventions/Control_2 | One control food is extracted by 150mL of hot water. Intake the control food extract 3 times a day for 12 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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | (1) Males and Females aged 20 to 59 years old when informed consent.
(2) Subjects who show understanding of the clinical study procedures and agreement with participating the study by written informed consent. |
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Key exclusion criteria | (1)Subjects who have infected influenza between 8 months ago from informed consent and 24 hours before test start.
(2) Subjects who have injected influenza vaccine within 8 months from informed consent. (3) Subjects who ingesting Food for Specified Health Use (FOSHU), functional indication food and health food on a daily bases. And subjects who will not quit ingesting them during test period. (4) Subjects who have allergy to tea, such as green tea, oolong tea, black tea and/or barley tea. (5) Subjects who have custom of drinking tea more than 2L a day. (6) Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ). (7) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period. (8) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. (9) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. (10) Males who donated over 400mL blood and/or blood components within the last three month to the current study. (11) Females who donated over 400mL blood and/or blood components within the last four month to the current study. (12) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (13) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (14) Others who have been determined ineligible by principal investigator or sub-investigator. |
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Target sample size | 72 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Mitsui Norin Co., Ltd. | ||||||
Division name | R&D group | ||||||
Zip code | 426-0133 | ||||||
Address | 223-1, Miyabara, Fujieda-city, Shizuoka 426-0133, Japan | ||||||
TEL | 054-648-2600 | ||||||
masayuks@mitsui-norin.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | Mitsui Norin Co., Ltd. | ||||||
Division name | Fundamental development team, R&D group | ||||||
Zip code | 426-0133 | ||||||
Address | 223-1, Miyabara, Fujieda-city, Shizuoka 426-0133, Japan | ||||||
TEL | 054-648-2600 | ||||||
Homepage URL | |||||||
ytanaka@mitsui-norin.co.jp |
Sponsor | |
Institute | CPCC Company Limited |
Institute | |
Department |
Funding Source | |
Organization | Mitsui Norin 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 | Institutional Review Board of Chiyoda Paramedical Care Clinic |
Address | 2F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan |
Tel | 03-5297-5548 |
IRB@cpcc.co.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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043507 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |