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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032263
Receipt No. R000036794
Scientific Title Experimental study of the multimodal homeostasis evaluation system by intake of adlay
Date of disclosure of the study information 2018/04/19
Last modified on 2018/09/11

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Basic information
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
Condition Healthy Adults
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

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 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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Healthcare Systems Co., Ltd.
Institute
Department

Funding Source
Organization Cabinet Office, Government of Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Aichi Gakuin University
Control of innate immunity TRA
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
2018 Year 04 Month 19 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
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
Other related information

Management information
Registered date
2018 Year 04 Month 16 Day
Last modified on
2018 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036794

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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