UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042134 |
|---|---|
| Receipt number | R000048087 |
| Scientific Title | Research on the relationship between postprandial glycemic response and intestinal environment / lifestyle |
| Date of disclosure of the study information | 2020/10/18 |
| Last modified on | 2022/02/15 08:56:16 |
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Basic information
Public title
Research on the relationship between postprandial glycemic response and intestinal environment / lifestyle
Acronym
Research on the relationship between PPGR and intestinal environment
Scientific Title
Research on the relationship between postprandial glycemic response and intestinal environment / lifestyle
Scientific Title:Acronym
Research on the relationship between PPGR and intestinal environment
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between blood glucose level, gut microbiome and lifestyle in Japanese
Basic objectives2
Others
Basic objectives -Others
To clarify the relationship between blood glucose level and gut microbiome
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose level
Gut microbiome
Key secondary outcomes
Oral microbiome
Blood profile
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Participants who are Males or Females aged 20 to 70 years at the time of screening test
2. Participants who are non-diabetic participants
3. Participants who have BMI values 18 to 30
4. Participants who have decision making skills and received sufficient study explanation. Participants who agree in writing to join the project independently after understanding the study explanation
Key exclusion criteria
1. Participants who use antibiotics prior to or during study
2. Participants who are under diabetes or digestive disease treatments
3. Participants who use cardiac pacemaker device or implantable cardioverter defibrillator
4. Participants who have food allergy
5. Participants who cannot use cooking devices (e.g. microwave oven, can opener or kitchen scale)
6. Participants who are inevitable to hard exercise or manual labor during study period
7. Participants who will plan to have X-ray, CT scan or MRI taken during study period
8. Participants who will be in the water over 30 min per day during study period
9. Participants who have difficulty using mobile phones or sleep/activity measuring instrument
10. Participants who have a clinical history of drug dependence or alcoholic
11. Participants who enroll in an another clinical trial
12. Participants who are pregnancy, lactation, or planning to become pregnant
13. Participants who are judged as a unsuited for the study by principal investigator
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | (1)Toru (2)Masahiko |
| Middle name | |
| Last name | (1)Sagami (2)Tokushima |
Organization
(1)Shinagawa Season Terrace Health Care Clinic
(2)Maebashi North Hospital
Division name
(1)Doctor (2)Director
Zip code
(1)108-0075 (2)371-0054
Address
(1)1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace (2)692 Shimohosoi-machi, Maebashi-shi, Gumma
TEL
03-3452-3382
shibaura@sempos.or.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building
TEL
03-3452-7733
Homepage URL
yoshikawa@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico 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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gumma
Tel
027-212-5608
sagawa@mc-connect.co.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
| 2020 | Year | 10 | Month | 18 | 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
| 2020 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To observe the relationship between blood glucose level and gut microbiome and lifestyle in Japanese
Management information
Registered date
| 2020 | Year | 10 | Month | 16 | Day |
Last modified on
| 2022 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048087
