UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037465 |
|---|---|
| Receipt number | 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 | 2020/04/02 16:36:15 |
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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
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
y-nishizaki@tokai.ac.jp
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
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
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
29
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 | 07 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 01 | Day |
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
| 2020 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042710
