UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036661 |
|---|---|
| Receipt number | R000041769 |
| Scientific Title | Study on the effects of meal frequency on glucose metabolism in subjects with normal glucose tolerance and impaired fasting glucose (g2010008) |
| Date of disclosure of the study information | 2019/05/07 |
| Last modified on | 2020/01/06 14:41:26 |
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Basic information
Public title
Study on the effects of meal frequency on glucose metabolism in subjects with normal glucose tolerance and impaired fasting glucose (g2010008)
Acronym
Effects of meal frequency on glucose metabolism
Scientific Title
Study on the effects of meal frequency on glucose metabolism in subjects with normal glucose tolerance and impaired fasting glucose (g2010008)
Scientific Title:Acronym
Effects of meal frequency on glucose metabolism
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of 3-day meal frequency on glucose metabolism in subjects with normal glucose tolerance and impaired fasting glucose.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glucose metabolism after intervention (blood glucose and insulin levels)
Key secondary outcomes
Daily variation in blood glucose using CGMs, and GLP-1, GLP, cortisol, keton-body after intervention.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants intake 3 meals per day for 3-day, after wash out for 2 weeks, intake 9 meals per day for 3-day
Interventions/Control_2
Participants intake 9 meals per day for 3-day, after wash out for 2 weeks, intake 3 meals per day for 3-day
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
(1) Subjects aged 30 to 59 years old.
(2) For impaired glucose tolerance, fasting blood glucose levels are <= 100 mg/dL and HbA1c levels are <=5.8%, for impaired glucose tolerance, fasting blood glucose level are between 110 mg/dL to 125 mg/dL and HbA1c levels are between 5.8%-6.4%.
(3) Subjects who can received study explanation and agree to participate in this study with written consent.
Key exclusion criteria
(1) Subjects who have serious cardio-vascular, hepatic, renal, respiratory, endocrine, metabolic, or gastrointestinal diseases, or who have a medical history of these diseases.
(2) Subjects who take medicine of hyperlipidemia or diabetes.
(3) Subjects who have food allergy.
(4) Subjects who is now included in other clinical studies, or who will participate in other clinical studies.
(5) Subjects who experienced unpleasant feeling during blood collection.
(6) Smoker
(7) Heavy drinker (Over 30g alcohol per day)
(8) Subjects who considered unsuitable for this study by the study investigators.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Sumio |
| Middle name | |
| Last name | Kondo |
Organization
Medical Corporation Kensho-kai, Fukushima Healthcare Center
Division name
Department of Internal Medicine, Neurosurgery
Zip code
553-0004
Address
2-12-16, Tamagawa, Fukushima-ku, Osaka
TEL
06-6441-6848
ko283434@ares.eonet.ne.jp
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Takano |
Organization
DRC Co., Ltd
Division name
Product Testing Department
Zip code
530-0044
Address
Tabuchi Bldg. No.9 5F , 2-10-31, Higashi-Temma, Kita-ku, Osaka
TEL
06-6882-1130
Homepage URL
m.takano@drc-web.co.jp
Sponsor or person
Institute
DRC Corporation, Ltd.
Product Testing Department
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
kenshokai ethics committee
Address
2-12-16 Tamagawa, Fukushima-ku, Osaka, 553-0004, Japan
Tel
06-6882-1130
ethics_board@drc-web.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
うえのあさがおクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 07 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2072-6643/11/9/2126
Number of participants that the trial has enrolled
20
Results
https://www.mdpi.com/2072-6643/11/9/2126
Results date posted
| 2019 | Year | 05 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 09 | Month | 06 | Day |
Baseline Characteristics
(1) Subjects aged 30 to 59 years old.
(2) For impaired glucose tolerance, fasting blood glucose levels are <= 100 mg/dL and HbA1c levels are <=5.8%, for impaired glucose tolerance, fasting blood glucose level are between 110 mg/dL to 125 mg/dL and HbA1c levels are between 5.8%-6.4%.
(3) Subjects who can received study explanation and agree to participate in this study with written consent.
Participant flow
Recruitment->Participation
Adverse events
none
Outcome measures
Glucose metabolism after intervention (blood glucose and insulin levels)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2010 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2010 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2011 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2011 | Year | 07 | Month | 30 | 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 | 05 | Month | 07 | Day |
Last modified on
| 2020 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041769
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| Registered date | File name |
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