UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042467
Receipt number R000048474
Scientific Title The effects of test food intake on immune function: Placebo-controlled, double-blind, randomized, pararellel-group comparison study-2
Date of disclosure of the study information 2021/06/30
Last modified on 2020/11/16 11:49:00

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Basic information

Public title

The effects of test food intake on immune function: Placebo-controlled, double-blind, randomized, pararellel-group comparison study-2

Acronym

The effects of test food intake on immune function-2

Scientific Title

The effects of test food intake on immune function: Placebo-controlled, double-blind, randomized, pararellel-group comparison study-2

Scientific Title:Acronym

The effects of test food intake on immune function-2

Region

Japan


Condition

Condition

healthy individuals

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Examination of the effects of test food intake on immune function

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Incidence and severity of the common cold (upper respiratory tract infections, influenza, tiredness), Wisconsin upper respiratory symptom survey-21 (WURSS-21), Salivary S-IgA, immunity evaluation, Subjective indicators of health-related quality of life

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of test food for 12 weeks

Interventions/Control_2

Ingestion of control food substance 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

20 years-old <=

Age-upper limit

64 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) Subjects of men and women aged 20 to 64
(2) Subjects feeling tired
(3) Subjects who feel their body is weakening
(4) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.

Key exclusion criteria

(1) Subjects with a history of diabetes, liver disease, renal disease, digestive system disease, heart disease, respiratory disease, peripheral angiopathy, and other diseases that may affect the results of this study, or subjects with surgical history
(2) Subjects with abnormal liver function and renal function test values
(3) Subjects with diseases currently being treated
(4) Subjects with food and drug allergies
(5) Subjects taking warfarin
(6) Subjects with anemia symptoms
(7) Subjects on a diet
(8) Subjects with irregular lives
(9) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period
(10) Subjects who are continuously taking medicines (including OTC and prescription medicines)
(11) Subjects who are excessively ingesting alcohol
(12) Subjects who cannot stop drinking from the day before the test to the day of the test
(13) Pregnant persons or subjects who are planning to become pregnant or breastfeed during the test period
(14) Subjects who are participating in or will participate in other clinical trials at the start of this study, and within 4 weeks after the end of the study.
(15) Other subjects judged by the investigator to be inappropriate

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Naoki
Middle name
Last name Miura

Organization

Miura Clinic, Medical Corporation Kanonkai

Division name

Internal Medicine

Zip code

530-0044

Address

Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka

TEL

0661355200

Email

info@miura-cl.jp


Public contact

Name of contact person

1st name Makoto
Middle name
Last name Terashima

Organization

Oneness Support Co., Ltd.

Division name

Clinical Trial Division

Zip code

530-0044

Address

Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka

TEL

0648018917

Homepage URL


Email

mterashima@oneness-sup.co.jp


Sponsor or person

Institute

Miura Clinic, Medical Corporation Kanonkai

Institute

Department

Personal name



Funding Source

Organization

euglena 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

Miura Clinic, Medical Corporation Kanonkai IRB

Address

Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka

Tel

0661355200

Email

mterashima@miura-cl.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

2021 Year 06 Month 30 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

2020 Year 10 Month 22 Day

Date of IRB

2020 Year 10 Month 22 Day

Anticipated trial start date

2020 Year 11 Month 17 Day

Last follow-up date

2021 Year 04 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

2020 Year 11 Month 16 Day

Last modified on

2020 Year 11 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048474


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name