UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000036661
Receipt No. 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 (Ver. 4)

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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
Email 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
Email m.takano@drc-web.co.jp

Sponsor
Institute DRC Corporation, Ltd.
Product Testing Department
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041769