UMIN-CTR Clinical Trial

Public title

Measurement of GI values of two kinds of test foods (chocolate).

Acronym

Measurement of GI values of two kinds of test foods.

Scientific Title

Measurement of GI values of two kinds of test foods (chocolate).

Scientific Title:Acronym

Measurement of GI values of two kinds of test foods.

Region

Japan

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Measure the GI values of two kinds of test foods (chocolate)

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

GI values of a test food 1 and a test food 2

Key secondary outcomes

Incremental area under the blood glucose response curve (IAUC), maximum blood glucose level (Cmax), amount of change in blood glucose levels after 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes after loading based on the blood glucose level before loading

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of a reference food - washout period - a test food 1 - washout period - a test food 2

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

50

years-old

>

Gender

Male and Female

Key inclusion criteria

(1) Subjects who have received sufficient explanation about the purpose and contents of this examination, have the ability to consent, fully volunteered with voluntary intention, agreed to participate in the document
(2) Healthy males and females aged between 20 and 50
(3) Women have a stable menstrual cycle
(4) Subjects who have a difference in the incremental area under the curve (IAUC) of two preliminary tests within 25%
(5) Subjects who can take a high cacao chocolate (75 g) within 12 minutes

Key exclusion criteria

(1) Subjects routinely taking medicine or health food which may influence glucose metabolism
(2) Subjects who have been pointed out as impaired glucose tolerance within 1 year
(3) Subjects whose BMI exceeds 30.0 kg/m^2
(4) Subjects whose blood glucose level exceeds 110 mg/dL
(5) Subjects who perform night shift more than once during the study period
(6) Subjects planned to travel abroad during the study period
(7) Subjects having possibilities for emerging allergy related to the current study
(8) Subjects who drink much alcohol
(9) Subjects who do excessive smoking
(10) Subjects who donated blood (blood donation etc.) exceeding 200 mL within 1 month or 400 mL within 4 months
(11) Subjects who has under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease)
(12) Subjects whose values of physical measurement, physical examination and clinical laboratory are significantly different from the reference range
(13) Subjects who may be pregnant or are pregnant, breastfeeding, or those who desire pregnancy during the study period
(14) Subjects who have participated in other clinical study within the last one month or have plan to participate other clinical studies
(15) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(16) Subjects who are judged as ineligible by the clinical investigator

Target sample size

14

Name of lead principal investigator

1st name
Middle name
Last name	Jiro Saito

Organization

Medical Station Clinic

Division name

None

Zip code

Address

3-12-8 takaban, meguro-ku, Tokyo, Japan

TEL

03-6452-2712

Email

info@med-station.jp

Name of contact person

1st name
Middle name
Last name	Shinsuke Tsuji

Organization

TTC Co., Ltd.

Division name

Clinical Research Planning Department

Zip code

Address

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

TEL

03-5459-5329

Homepage URL

Email

s.tsuji@ttc-tokyo.co.jp

Institute

TTC Co., Ltd

Institute

Department

Personal name

Organization

Meiji Co., Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

01

Month

30

Day

URL releasing protocol

Publication of results

Published

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

Recruitment status

Completed

Date of protocol fixation

2018

Year

06

Month

14

Day

Date of IRB

Anticipated trial start date

2018

Year

07

Month

02

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

06

Month

28

Day

Last modified on

2018

Year

11

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037841