UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043989
Receipt number R000050236
Scientific Title Evaluation of the effects of consumption of test foods containing plant-derived bioactive substances on the biomarker in blood: a preliminary study
Date of disclosure of the study information 2021/04/21
Last modified on 2021/10/20 12:57:08

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Basic information

Public title

Evaluation of the effects of consumption of test foods containing plant-derived bioactive substances on the biomarker in blood: a preliminary study

Acronym

Evaluation of the effects of consumption of test foods containing plant-derived bioactive substances on the biomarker in blood: a preliminary study

Scientific Title

Evaluation of the effects of consumption of test foods containing plant-derived bioactive substances on the biomarker in blood: a preliminary study

Scientific Title:Acronym

Evaluation of the effects of consumption of test foods containing plant-derived bioactive substances on the biomarker in blood: a preliminary study

Region

Japan


Condition

Condition

Healthy subjects

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effects of ingestion of plant-derived bioactive substances on blood biomarker concentrations. In addition, the effect of ingestion of plant-derived bioactive substances on appetite will be evaluated as the secondary endpoints.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Blood biomarker concentrations

Key secondary outcomes

Appetite score, nutrient intake


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake the test food for 4 weeks

Interventions/Control_2


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


Not applicable

Gender

Male and Female

Key inclusion criteria

1) males and females over 20 years old

Key exclusion criteria

1) Those who have factors other than dietary habits that greatly affect blood biomarker concentration (those who have an infectious disease within 1 month of the start of the study, those who take antibiotics within 1 month of the start of the study, those who have chronic digestive disorders, etc.)
2) Those who have factors other than blood biomarker concentration that greatly affect appetite (Those who eat less than two meals a day on some days,those who are undergoing hormone therapy, etc.)
3) Those who may have adverse events when collecting blood (those who are sensitive to alcohol to the extent that alcohol disinfection is difficult, those who have skin diseases on their fingers, etc.)
4) Those who may develop allergies due to ingestion of the test food
5) Those who regularly use health foods that contain a high amount of ingredients similar to those involved in the test food.
6) Those who regularly use health foods high in fructooligosaccharide / inulin, galactooligosaccharide, indigestible dextrin, and insoluble dietary fiber
7) Those who routinely ingest plant foods and their processed products that contain high amounts of ingredients similar to those involved in test foods.
8) Those who participated in other human studies within 1 month of the start of this study
9) Those who are lactating, pregnant, or who wish to become pregnant during the study period.
10) Those who are judged to be inappropriate by the investigator or the principal investigator

Target sample size

25


Research contact person

Name of lead principal investigator

1st name Yusuke
Middle name
Last name Ushida

Organization

KAGOME CO., LTD.

Division name

Nature & Wellness Research Department, Innovation Division

Zip code

329-2762

Address

17 Nishitomiyama, Nasushiobara, Tochigi, Japan

TEL

0287-36-2935

Email

Yusuke_Ushida@kagome.co.jp


Public contact

Name of contact person

1st name Nobuo
Middle name
Last name Fuke

Organization

KAGOME CO., LTD.

Division name

Nature & Wellness Research Department, Innovation Division

Zip code

329-2762

Address

17 Nishitomiyama, Nasushiobara, Tochigi, Japan

TEL

0287-36-2935

Homepage URL


Email

Nobuo_Fuke@kagome.co.jp


Sponsor or person

Institute

KAGOME CO., LTD.

Institute

Department

Personal name



Funding Source

Organization

KAGOME 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

the ethics committees of KAGOME CO., LTD.

Address

3-21-1, F tower, Hamacho, Nihonbashi, Tyuo-ku, Tokyo, Japan

Tel

03-5623-8501

Email

Takuji_Hayakawa@kagome.co.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

2021-R02

Org. issuing International ID_1

the ethics committees of KAGOME CO., LTD.

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

カゴメ株式会社(栃木県)


Other administrative information

Date of disclosure of the study information

2021 Year 04 Month 21 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

25

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

2021 Year 04 Month 06 Day

Date of IRB

2021 Year 04 Month 20 Day

Anticipated trial start date

2021 Year 05 Month 12 Day

Last follow-up date

2021 Year 07 Month 02 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 20 Day

Last modified on

2021 Year 10 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050236


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name