UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050266 |
|---|---|
| Receipt number | R000052622 |
| Scientific Title | Effect of food order and eating speed on postprandial glucose and serum insulin-randomized cross-over trial |
| Date of disclosure of the study information | 2023/02/09 |
| Last modified on | 2023/08/10 13:29:20 |
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Basic information
Public title
Effect of food order and eating speed on postprandial glucose and serum insulin
Acronym
Effect of food order and eating speed on postprandial glucose and serum insulin
Scientific Title
Effect of food order and eating speed on postprandial glucose and serum insulin-randomized cross-over trial
Scientific Title:Acronym
Effect of food order and eating speed on postprandial glucose and serum insulin
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this randomized cross-over study is to investigate the effect of food order and eating speed on postprandial glucose and serum insulin concentration in healhty adults.
Basic objectives2
Others
Basic objectives -Others
We investigate the food order and eating speed on postprandial glucose and serum insulin concentration in healthy adults.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Postprandial glucose concentration
Key secondary outcomes
Incremental glucose peak, serum insulin concentration
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
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
The participants consume test meals as mentioned such as intervention 1, 2, and 3 in randomized cross-over study.
The participants consumed test meal(breakfast), carbohydrate first, main dish, and vegetable for 20 min and blood samples are examined 0, 30, 60, and 120 min to examine postprandial glucose and insulin concentrations.
Interventions/Control_2
The participants consumed test meal(breakfast), vegetable first, main dish, and carbohydrate last for 20 min and blood samples are examined 0, 30, 60, and 120 min to examine postprandial glucose and insulin concentrations.
Interventions/Control_3
The participants consumed test meal(breakfast), vegetable first, main dish, and carbohydrate last for 10 min and blood samples are examined 0, 30, 60, and 120 min to examine postprandial glucose and insulin concentrations.
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
| 35 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy adults
2. Individual who written informed consents have been obtained
3. Individual 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. Pregnant women and Women with possibility of pregnancy
4. Severe health problems not suitable for the study
Target sample size
23
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
imais@kyoto-wu.ac.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
https://www.kyoto-wu.ac.jp/club/?utm_source=yahoo&utm_medium=cpc&yclid=YSS.1001075864.EAIaIQobChMIlY
imais@kyoto-wu.ac.jp
Sponsor or person
Institute
Department of Food and Nutrition, Kyoto Women's University
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI Grant Number 20K11569
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Women's University
Address
35, Imakumano, Kitahiyoshi-cho, HIgashiyama-ku, Kyoto
Tel
075-531-7123
kawazoe@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
| 2023 | Year | 02 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://repo.kyoto-wu.ac.jp/dspace/handle/11173/3393
Number of participants that the trial has enrolled
19
Results
Our aim was to evaluate the acute effect of eating main dish first, then carbohydrate, and vegetable last on glycemic parameters of randomized controlled cross-over trial in young healthy women. Nineteen women wore a flash glucose monitoring system for 7 days. The results suggest that eating main dish first is not associated to decrease the postprandial glucose concentrations compared to those in eating vegetable, main dish, carbohydrate in healthy women.
Results date posted
| 2023 | Year | 08 | Month | 10 | 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
Main results already published
Date of protocol fixation
| 2021 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 10 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 10 | Day |
Date analysis concluded
| 2023 | Year | 01 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 08 | Day |
Last modified on
| 2023 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052622
