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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038684
Receipt No. R000042686
Scientific Title Effect of quick eating on postprandial glucose in healthy people-Randomized crossover study
Date of disclosure of the study information 2019/12/01
Last modified on 2019/11/25

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Basic information
Public title Effect of quick eating on postprandial glucose in healthy people
Acronym Effect of quick eating on postprandial glucose in healthy people
Scientific Title Effect of quick eating on postprandial glucose in healthy people-Randomized crossover study
Scientific Title:Acronym Effect of quick eating on postprandial glucose
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this radomized crossover study is to investigate the effect of consuming meals quickly on postprandial glucose in healthy adults.
Basic objectives2 Others
Basic objectives -Others We investigat the quick or slow eating on postprandial gucose and glucose excursions in healthy adults.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Postprandial glucose after quick and slow eating.
Key secondary outcomes Area under the curve for glucose, amplitude of glycemic excursions

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 NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment Pseudo-randomization

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Food Behavior,custom
Interventions/Control_1 The participants wear flash glucose monitoring (FGM) and consume test meals slowly (20 min)from vegetable, main dish, and carbohydrate on day 3 or day 5.
Interventions/Control_2 The participants consume test meals quickly (10 min)on day 4.
Interventions/Control_3 The participants consume test meals slowly (20 min) from carbohydrate, main dish, and vegetable on day 3 or day 5. The blood glucose parameters are compared among test days.
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
40 years-old >
Gender Male and Female
Key inclusion criteria 1.Healthy adults
2.Individuals whose written informed consents have been obtained
3.Individuals who are judged appropriate for the study by the principal
Key exclusion criteria 1. Patients with type 1 and type 2 diabetes
2. Treatment with steroid
3. Women with possibility of pregnancy
4. Severe health problems not suitable for the study
Target sample size 25

Research contact person
Name of lead principal investigator
1st name Saeko
Middle name
Last name Imai
Organization Kyoto Women's University
Division name Department of Food and Nutrition
Zip code 605-8501
Address 35, Imakumano, Kitahiyoshi-cho, Higashiyama-ku, Kyoto
TEL 075-531-7128
Email imais@kyoto-wu.c.jp

Public contact
Name of contact person
1st name Saeko
Middle name
Last name Imai
Organization Kyoto Women's University
Division name Department of Food and Nutrition
Zip code 605-8501
Address 35, Imakumano, Kitahiyoshi-cho, Higashiyama-ku, Kyoto
TEL 075-531-7128
Homepage URL http://www.kyoto-wu.ac.jp/
Email imais@kyoto-wu.ac.jp

Sponsor
Institute Department of Food and Nutrition
Kyoto Women's University
Institute
Department

Funding Source
Organization Department of Food and Nutrition
Kyoto Women's University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Kajiyama Clinic, Kyoto
Name of secondary funder(s) Kyoto Women's University

IRB Contact (For public release)
Organization Kyoto Women's University
Address 35, Imakumano, Kitahiyoshi-cho, Higashiyama-ku, Kyoto
Tel 075-531-7128
Email imais@kyoto-wu.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 京都女子大学(京都市)

Other administrative information
Date of disclosure of the study information
2019 Year 12 Month 01 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 Enrolling by invitation
Date of protocol fixation
2019 Year 04 Month 15 Day
Date of IRB
2019 Year 06 Month 18 Day
Anticipated trial start date
2019 Year 08 Month 01 Day
Last follow-up date
2022 Year 03 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 11 Month 25 Day
Last modified on
2019 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042686

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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