UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041590
Receipt number R000047481
Scientific Title Investigation of GI value and second meal effect of the test food for adult males and females
Date of disclosure of the study information 2020/08/28
Last modified on 2021/01/28 11:25:16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Investigation of GI value and second meal effect of the test food for adult males and females

Acronym

Investigation of GI value and second meal effect of the test food

Scientific Title

Investigation of GI value and second meal effect of the test food for adult males and females

Scientific Title:Acronym

Investigation of GI value and second meal effect of the test food

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Measure the GI level of the test food and investigate the effects on glucose, insulin levels and second meal effects

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Glycemic Index

Key secondary outcomes

Maximum blood glucose level (Cmax), Incremental area under the blood glucose response curve (IAUC), Area under the curve (AUC)

Maximum insulin level (Cmax),
Incremental area under the insulin response curve (IAUC), Area under the curve (AUC)

Change in blood glucose levels based on the blood glucose level before test food ingestion

Change in insulin levels based on the insulin level before test food ingestion

Change in blood glucose levels based on the blood glucose level before second meal ingestion

Change in insulin levels based on the insulin level before second meal ingestion

Change in questionnaire on appetite (VAS-questionnaire) based on the appetite (VAS-questionnaire) before test food ingestion


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of a reference food (single ingestion) - washout period - Intake of a reference food (single ingestion) - washout period - Intake of a reference food (single ingestion) - washout period - Intake of a test food 1 and second meal (single ingestion) - washout period - Intake of a test food 2 and second meal (single ingestion)

Interventions/Control_2

Intake of a reference food (single ingestion) - washout period - Intake of a reference food (single ingestion) - washout period - Intake of a reference food (single ingestion) - washout period - Intake of a test food 2 and second meal (single ingestion) - washout period - Intake of a test food 1 and second meal (single ingestion)

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

20 years-old <=

Age-upper limit

50 years-old >

Gender

Male and Female

Key inclusion criteria

(1) Healthy males and females aged between 20 and 50
(2) Subjects who are appropriate based on the IAUC of the test using the reference food (Stage I to III)
(3) Women have a stable menstrual cycle
(4) Subjects with blood glucose level greater than 70 mg /dL or more and 110 mg /dL or less in glucometer

Key exclusion criteria

(1) Subjects who have a history of diabetes
(2) Subjects who are diabetic borderline in stage I to III (Fasting plasma glucose level is >= 110 mg/dL or glucose level after a reference food load of 120 minutes is >= 140 mg/dL)
(3) Subjects who have a habit of smoking
(4) Subjects with BMI of 25.0 kg/m2 or more or less than 18.5 kg/m2
(5) Subjects routinely taking medicine or health food which may influence glucose metabolism
(6) Subjects who have been indicated as abnormal with impaired glucose tolerance test prior 1 year prior to stage I
(7) Subjects who are suspected to have abnormal glucose tolerance in stage I
(8) Subjects who are planning to travel abroad during the study period
(9) Subjects having possibilities for emerging allergy related to the study
(10) Subjects who consume large amounts of alcohol (the average alcohol amount is 60 g / day or more)
(11) Subjects having blood sample of 200 ml or more taken within one month, or 400 ml or more within 4 months prior to the start of the study
(12) Subjects who has under treatment or a history of serious disease (e.g., liver disease, kidney disease, heart disease, or gastrointestinal disease)
(13) Subjects who has under treatment or a history of serious disease that affects the evalution of the study (e.g., obesity, dyslipidemia, or hypertension)
(14) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(15) Subjects who intend to become pregnant or lactating
(16) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
(17) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(18) Subjects judged as unsuitable for the study by the investigator for other reasons

Target sample size

16


Research contact person

Name of lead principal investigator

1st name Shizuya
Middle name
Last name Kabuto

Organization

Mizkan Holdings Co., Ltd.

Division name

Central Research Institute

Zip code

475-8585

Address

2-6, nakamura-cho, handa-shi, Aichi

TEL

0569-24-5139

Email

kabuto@mizkan.co.jp


Public contact

Name of contact person

1st name Hiroyasu
Middle name
Last name Shimada

Organization

TTC Co., Ltd.

Division name

Clinical Research Planning Department

Zip code

150-0021

Address

Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL


Email

h.shimada@ttc-tokyo.co.jp


Sponsor or person

Institute

TTC Co., Ltd

Institute

Department

Personal name



Funding Source

Organization

Mizkan Holdings Co., Ltd.

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

Medical Station Clinic Research Ethics Committee

Address

3-12-8, Takaban, Meguroku, Tokyo

Tel

03-6452-2712

Email

t.saito@ttc-smo.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



Other administrative information

Date of disclosure of the study information

2020 Year 08 Month 28 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

16

Results

Results date posted

2021 Year 01 Month 28 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

Completed

Date of protocol fixation

2020 Year 08 Month 20 Day

Date of IRB

2020 Year 08 Month 20 Day

Anticipated trial start date

2020 Year 08 Month 28 Day

Last follow-up date

2020 Year 09 Month 26 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 08 Month 28 Day

Last modified on

2021 Year 01 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047481


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name