UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038684
Receipt number 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 2021/11/22 11:56:52

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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

35 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 or person

Institute

Department of Food and Nutrition
Kyoto Women's University

Institute

Department

Personal name



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

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7551722/

Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7551722/

Number of participants that the trial has enrolled

19

Results

The mean amplitude of glycemic excursion, incremental glucose peak, and incremental area under the curve for glucose of dinner 2 h for fast eating were all significantly higher than those for slow eating. The results suggest that fast eating is associated with higher glycemic excursion in healthy women.

Results date posted

2021 Year 11 Month 22 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

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

2023 Year 03 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7551722/


Management information

Registered date

2019 Year 11 Month 25 Day

Last modified on

2021 Year 11 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042686


Research Plan
Registered date File name
2021/11/22 nutrients-12-02767-v2 (2).pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name