UMIN-CTR Clinical Trial

Public title

Experimental study of the multimodal homeostasis evaluation system by intake of adlay

Acronym

Experimental study of the multimodal homeostasis evaluation system by intake of adlay

Scientific Title

Experimental study of the multimodal homeostasis evaluation system by intake of adlay

Scientific Title:Acronym

Experimental study of the multimodal homeostasis evaluation system by intake of adlay

Region

Japan

Condition

Healthy Adults

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Evaluate the multimodal homeostasis evaluation systems using adlay as a test food.

Basic objectives2

Others

Basic objectives -Others

Evaluate the correlation with existing measurement items and verify the usefulness of this system.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Multimodal homeostasis evaluation systems

Key secondary outcomes

Self-awareness questionnaire, diet survey, physical examination, general blood biochemical examination, peripheral blood general examination, antioxidant / anti-inflammatory marker, transcriptome analysis, oxidative stress, intestinal environment, stress marker

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Adlay tea for 8 weeks

Interventions/Control_2

Barley tea for 8 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

Age-lower limit

20

years-old

<=

Age-upper limit

64

years-old

>=

Gender

Male and Female

Key inclusion criteria

1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2.Healthy Japanese who is 20 years old or more and under 64 years old

Key exclusion criteria

1.Persons who have chronic illness, receiving medication, have a serious disease history
2.Persons whose LDL cholesterol is over 140 mg / dL at screening
3.Persons whose serum neutral fat is over 150 mg / dL at screening
4.Persons whose systolic blood pressure is over 140 mmHg or diastolic blood pressure is over 90 mmHg at screening
5.Persons whose fasting blood glucose l is over 126 mg / dL at screening
6.Persons whose BMI is over 25 kg/m2 at screening
7.Persons who are allergic to the test food
8.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
9.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
10.Persons who were judged as inappropriate for subjects by the principal investigator

Target sample size

120

Name of lead principal investigator

1st name
Middle name
Last name	Hirohito Ishikawa

Organization

Healthcare Systems Co., Ltd.

Division name

Research and Development

Zip code

Address

Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN

TEL

03-6809-2722

Email

ishikawa@hc-sys.jp

Name of contact person

1st name
Middle name
Last name	Hirohito Ishikawa

Organization

Healthcare Systems Co., Ltd.

Division name

Research and Development

Zip code

Address

Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN

TEL

03-6809-2722

Homepage URL

Email

ishikawa@hc-sys.jp

Institute

Healthcare Systems Co., Ltd.

Institute

Department

Personal name

Organization

Cabinet Office, Government of Japan

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Aichi Gakuin University
Control of innate immunity TRA

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

04

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2018

Year

03

Month

13

Day

Date of IRB

Anticipated trial start date

2018

Year

04

Month

20

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

04

Month

16

Day

Last modified on

2018

Year

09

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036794