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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044042
Receipt No. 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

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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
Email 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
Email umeda.mai@kao.com

Sponsor
Institute Kao Corporation
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050290

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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