UMIN-CTR Clinical Trial

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
Email	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
Email	yoshikawa@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048087