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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037465
Receipt No. R000042710
Scientific Title A study on the effects of test food on glucose behavior in human
Date of disclosure of the study information 2019/07/24
Last modified on 2019/07/24

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Basic information
Public title A study on the effects of test food on glucose behavior in human
Acronym A study on the effects of test food on glucose behavior in human
Scientific Title A study on the effects of test food on glucose behavior in human
Scientific Title:Acronym A study on the effects of test food on glucose behavior in human
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of test food on glucose behavior in human.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood glucose levels, persistently measured by FreeStyle Libre Sensor (Abbott).
Key secondary outcomes Questionnaire : Sense of hunger
Glycometabolism : HbA1c, FBS
Liver function : ALT, AST, Gamma-GTP, Total Bilirubin, Albumin, ALP
Renal function : Serum Creatinine
Serum lipid : TC, TG, LDL-C, HDL-C, RLP-C
Anthropometry : Weight, Abdominal circumference, Blood pressure, Body fat percentage, Physical activity

Base
Study type Interventional

Study design
Basic design Cross-over
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 Treatment
Type of intervention
Food
Interventions/Control_1 Consume one test food a day (for 3day)->Washout (for 4 days) -> Consume one placebo food a day (for 3day)
Interventions/Control_2 Consume one placebo food a day (for 3day)-> Washout (for 4 days) -> Consume one test food a day (for 3day)
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
60 years-old >
Gender Male and Female
Key inclusion criteria 1.Healthy volunteer
2.Males and females aged between 20 and 59.
3. Subjects who receive adequate explanation for participation in this research and provide informed consent in writing by their own free will.
4. Subjects who can take certainly foods according to instructions, and understand how to use wearable blood glucose monitoring equipment and wearable physical activity meter.
Subjects who can write Life diary and Questionnaire.
5. Subjects who are judged suitable for this study by principal investigator and doctors.
Key exclusion criteria 1. Subjects with diabetes or borderline diabetes.
2. Subjects who fall under any of the following: ALT>200 IU/L, AST>200 IU/L, Gamma-GTP>200 IU/L, Total Bilirubin>2.0g/dl.
3. Subjects who are suspected acute and subacute hepatopathy.
4. Subjects with serious heart problems.
5. Subjects with renal dysfunction (serum creatinine > 2.0 mg/dL).
6. Subjects with tumor bearing.
7. Subjects who can't take medication according to instructions.
8. Subjects who had serious disease or have disease in treatment, and who are judged not to be suitable for this study.
9. Subjects with risk of allergy related to this study.
10. Subjects who have symptoms such as fever, sore throat, cough, diarrhea, vomiting etc and are suspected acute infectious diseases.
11. Subjects who participated in other clinical trials within 2 months.
12. Subjects who continuously take dietary fiber or supplements, foods for specified health use , that contain substances affecting blood glucose levels.
13. Subjects who are judged unsuitable for this study by principal investigator and doctors.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Yasuhiro
Middle name
Last name Nishizaki
Organization Tokai University School of Medicine
Division name Dept. of Clinical Health Science
Zip code 151-0053
Address 1-2-5 Yoyogi, Shibuya-ku, Tokyo, Japan Tokai University Tokyo Hospital
TEL 03-3370-2321
Email y-nishizaki@tokai.ac.jp

Public contact
Name of contact person
1st name Yasuhiro
Middle name
Last name Nishizaki
Organization Tokai University School of Medicine
Division name Dept. of Clinical Health Science
Zip code 151-0053
Address 1-2-5 Yoyogi, Shibuya-ku, Tokyo, Japan Tokai University Tokyo Hospital
TEL 03-3370-2321
Homepage URL
Email y-nishizaki@tokai.ac.jp

Sponsor
Institute Tokai University School of Medicine
Institute
Department

Funding Source
Organization Mizkan Holdings 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 Institutional Review Board for Clinical Research, Tokai University
Address 143 Shimokasuya, Isehara, Kanagawa 259-1193, JAPAN
Tel 0463-93-1121
Email tokai-rinsho@ml.tokai-u.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
2019 Year 07 Month 24 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
2019 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date
2019 Year 08 Month 01 Day
Last follow-up date
2020 Year 02 Month 29 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 07 Month 24 Day
Last modified on
2019 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042710

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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