UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044042 |
|---|---|
| Receipt number | R000050290 |
| Scientific Title | A study on the effect of plant extract-containing beverages on immune function [Trial No. g2021004 (KO24)] |
| Date of disclosure of the study information | 2021/05/01 |
| Last modified on | 2021/04/26 15:59:40 |
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Basic information
Public title
A study on the effect of plant extract-containing beverages on immune function [Trial No. g2021004 (KO24)]
Acronym
A study on the effect of plant extract-containing beverages on immune function
Scientific Title
A study on the effect of plant extract-containing beverages on immune function [Trial No. g2021004 (KO24)]
Scientific Title:Acronym
A study on the effect of plant extract-containing beverages on immune function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of continuous intake of plant extract-containing beverages on immune function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of NK cell activity after continuous ingestion of plant extract-containing beverage for 2 weeks
Key secondary outcomes
Evaluation of IFN-g after continuous ingestion of plant extract-containing beverage for 2 weeks
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingest a beverage containing plant extract once a day for 2 consecutive weeks -> Wash out(4wks) -> Ingest a beverage containing no plant extract once a day for 2 consecutive weeks.
Interventions/Control_2
Ingest a beverage containing no plant extract once a day for 2 consecutive weeks -> Wash out(4wks) -> Ingest a beverage containing plant extract once a day for 2 consecutive 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
| 55 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Healthy men and women aged 55 to 64
(2)Those who can take test foods and write a life diary
Key exclusion criteria
(1) During the test period, Subjects who may develop seasonal allergic symptoms such as pollinosis and may use medicines, or who are receiving medication related to it
(2) Those who may have allergic symptoms to the test food.
(3) Those who have had strokes due to cardiovascular disease (heart failure, angina, stroke, subarachnoid hemorrhage, etc.) or who are being treated.
(4) Those with a history or signs of cerebrovascular disease or cardiovascular disease.
(5) Those who suffering from liver disease, renal disease, respiratory disease, endocrine disorder, metabolic disorder, organ disorder, ventilation, rheumatism, autoimmune disease, psychiatric disease, cancer, infectious disease, etc.
(6) Those with a history of gastrointestinal resection (excluding cecal resection)
(7) Alcoholic drinkers (alcohol equivalent 60g / day or more)
(8) Those who collected 200 mL of blood (donated blood, etc.) within 1 month or 400 mL or more within 3 months of the start of this study.
(9) Those who have felt sick at the time of blood collection, or those who have difficulty in collecting blood because the blood vessels in the arm are difficult to see.
(10) Those who are not day shifts such as night shifts and rotation shifts
(11) Those who cannot take all the test foods
(12) Those who have a history of vaccination (including influenza) 4 weeks before the start of the study
(13) Within the last 2 weeks, those who have had mild wind symptoms such as fever, cough, sore throat (symptoms lasting more than 4 days), high fever, dyspnea, strong malaise, dysgeusia, or olfactory dysfunction or who have these now.
(14) Those who have traveled abroad within one month
(15) Those who plan to participate in other clinical trials during the trial participation period
(16) Those deemed inappropriate to participate in this study by the principle investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hidefumi |
| Middle name | |
| Last name | Kitazawa |
Organization
Kao Corporation
Division name
Biological Science Research laboratories
Zip code
130-0025
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL
+81-3-5630-7260
kitazawa.hidefumi@kao.com
Public contact
Name of contact person
| 1st name | Mai |
| Middle name | |
| Last name | Umeda |
Organization
Kao Corporation
Division name
Biological Science Research laboratories
Zip code
130-0025
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL
+81-3-5630-7260
Homepage URL
umeda.mai@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Preferred Networks
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Ueno-asagao Clinic
Address
Kairaku Bld. 6F, 2-7-5, Higashi-ueno, taito-ku, Tokyo, 110-0015, JAPAN
Tel
+81-3-6240-1162
info@ueno-asagao.clinic
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
うえのあさがおクリニック(東京)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 30 | 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 | 04 | Month | 26 | Day |
Last modified on
| 2021 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050290
