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

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 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

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

Value
https://center6.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