UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036090
Receipt number R000041116
Scientific Title Preliminary study on the effect of functional food on Blood inflammatory marker in human
Date of disclosure of the study information 2019/03/06
Last modified on 2020/09/28 18:29:16

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Basic information

Public title

Preliminary study on the effect of functional food on Blood inflammatory marker in human

Acronym

Preliminary study on the effect of functional food on Blood inflammatory marker in human

Scientific Title

Preliminary study on the effect of functional food on Blood inflammatory marker in human

Scientific Title:Acronym

Preliminary study on the effect of functional food on Blood inflammatory marker in human

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of functional food on Blood inflammatory marker in human.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Blood inflammatory marker

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

Functional food, 4 weeks

Interventions/Control_2

Food without functional food, 4 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

40 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

(1) Subjects whose are 40 <= years old < 65.
(2) Subjects who can visit hospital on designated day.
(3) Subject who is able to give written informed consent before the study.

Key exclusion criteria

(1) Subjects whose systolic blood pressure is less than 90mmHg
(2) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period
(3) Subjects who donated 200 mL of blood and/or blood components within four weeks prior to the current study
(4) Males whose blood was collected more than 400 mL within the last 12 weeks
(5) Females whose blood was collected more than 400 mL within the last 16 weeks
(6) Males whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added
(7) Females whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added
(8) Subjects who are participating in other clinical studies for drug medicine or food, or who finished clinical study within four weeks
(9) Subjects who drink alcohol a lot
(10) Subjects who have a habit of smoking
(11) Subjects who are with treatment
(12) Subjects who constantly use drug medicine
(13) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuji Nonaka

Organization

SUNTORY GLOBAL INNOVATION CENTER LIMITED

Division name

Research Institute

Zip code


Address

8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan

TEL

050-3182-0587

Email

Yuji_Nonaka@suntory.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takatsugu Tsuchiya

Organization

SUNTORY GLOBAL INNOVATION CENTER LIMITED

Division name

Research Institute

Zip code


Address

8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan

TEL

050-3182-0567

Homepage URL


Email

Takatsugu_Tsuchiya@suntory.co.jp


Sponsor or person

Institute

SUNTORY GLOBAL INNOVATION CENTER LIMITED

Institute

Department

Personal name



Funding Source

Organization

SUNTORY GLOBAL INNOVATION CENTER LIMITED

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2019 Year 03 Month 06 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

Completed

Date of protocol fixation

2019 Year 03 Month 04 Day

Date of IRB

2019 Year 03 Month 04 Day

Anticipated trial start date

2019 Year 03 Month 07 Day

Last follow-up date

2019 Year 09 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

2019 Year 03 Month 05 Day

Last modified on

2020 Year 09 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041116


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name