UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000034078
Receipt No. R000038849
Scientific Title Evaluation of meal response by blood glucose monitor for personalized nutrition -pilot study-
Date of disclosure of the study information 2018/09/19
Last modified on 2019/09/03 (Ver. 6)

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Basic information
Public title Evaluation of meal response by blood glucose monitor for personalized nutrition -pilot study-
Acronym Pilot study on the evaluation of meal response by blood glucose monitor
Scientific Title Evaluation of meal response by blood glucose monitor for personalized nutrition -pilot study-
Scientific Title:Acronym Pilot study on the evaluation of meal response by blood glucose monitor
Region
Japan

Condition
Condition Healthy male
Classification by specialty
Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To compare the difference in the postprandial blood glucose level in healthy adults, who ingest a low glycemic index (GI) or a high GI test meal as breakfast for 7 days.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes blood glucose, serum insulin
Key secondary outcomes Anthropometry, Clinical laboratory test, Biological markers

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Ingestion of a low GI test meal for breakfast for 7 days
Interventions/Control_2 Ingestion of a high GI test meal for breakfast for 7 days
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
40 years-old <=
Age-upper limit
70 years-old >
Gender Male
Key inclusion criteria Japanese men aged between 40 and 70 years old
Key exclusion criteria 1.Persons using implantable medical devices such as pacemakers
2.Persons undergoing dialysis
3.Person under medication
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Toshinao
Middle name
Last name Goda
Organization University of Shizuoka
Division name School of Food and Nutritional Sciences
Zip code 422-8526
Address 52-1 Yada, Suruga-ku, Shizuoka 422-8526 Japan
TEL 054-264-5533
Email gouda@u-shizuoka-ken.ac.jp

Public contact
Name of contact person
1st name Toshinao
Middle name
Last name Goda
Organization University of Shizuoka
Division name School of Food and Nutritional Sciences
Zip code 422-8526
Address 52-1 Yada, Suruga-ku, Shizuoka 422-8526 Japan
TEL 054-264-5533
Homepage URL
Email gouda@u-shizuoka-ken.ac.jp

Sponsor
Institute University of Shizuoka, School of Food and Nutritional Sciences
Institute
Department

Funding Source
Organization The KAITEKI Institute, Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Research Center for Integrative Medical Science (IMS), RIKEN
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research ethics committee of the University of Shizuoka
Address 52-1 Yada, Suruga-ku, Shizuoka 422-8526 Japan
Tel 054-264-5102
Email tyous10@u-shizuoka-ken.ac.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 SBS静岡健康増進センター（静岡県）／SBS Shizuoka Health Promotion Center　（Shizuoka）

Other administrative information
Date of disclosure of the study information
2018 Year 09 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 20
Results 
The blood glucose levels were significantly higher who intake high-GI diet at 30 minutes, 60 minutes and 120 minutes after starting breakfast ingestion than in who intake low-GI diet.
Results date posted
2019 Year 09 Month 03 Day
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 08 Month 08 Day
Date of IRB
2018 Year 08 Month 08 Day
Anticipated trial start date
2018 Year 09 Month 19 Day
Last follow-up date
2018 Year 11 Month 08 Day
Date of closure to data entry
2019 Year 08 Month 31 Day
Date trial data considered complete
2019 Year 08 Month 31 Day
Date analysis concluded
2019 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 09 Month 10 Day
Last modified on
2019 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038849