UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031163
Receipt number R000035415
Scientific Title Effect on blood sugar level by single intake of ice creams
Date of disclosure of the study information 2018/02/07
Last modified on 2018/08/10 17:15:55

* 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

Effect on blood sugar level by single intake of ice creams

Acronym

Blood sugar level test

Scientific Title

Effect on blood sugar level by single intake of ice creams

Scientific Title:Acronym

Blood sugar level test

Region

Japan


Condition

Condition

Healthy individual

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Confirm the effect of blood sugar level by orally ingesting ice creams containing different carbohydrate and fat amount

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

blood sugar level
Blood sampling should be done before the start of ice cream ingestion, at 20,
40, 60, 80 minutes after ingestion

Key secondary outcomes

Insulin value, GLP-1, leptin, triglyceride, glucoalbumin, AGEs
Blood sampling should be done before the start of ice cream ingestion, at 20,
40, 60, 80 minutes after ingestion


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ice cream (70 g, error range 5 g)
carbohydrates 15.4 g, lipids 9.4 g, energy 155 kcal, single intake

Interventions/Control_2

Ice cream (70 g, error range 5 g)
carbohydrates 7.7 g , lipids 6.3 g , energy 80 kcal, single intake

Interventions/Control_3

Ice cream (70 g, error range 5 g)
carbohydrates 7.7 g , lipids 12.7 g , energy 155 kcal, single intake

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

59 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Japanese men and women aged 20 to 59 years old at the time of acquisition
2) Fasting blood glucose level is 100 mg / dl or less
3) Healthy person (A healthy person in this test means a person who has no serious organ disorder or disease, has not received treatment related to them, or who has not received any medication therapy. This judgement is based on the declaration of the individual at the start of the examination)
4) Those who can withdraw blood samples multiple times with an indwelling needle
5) Those who can fast from 10 hours or more before the visits on all days of the screening and this examination (only water (mineral water) can be taken)

Key exclusion criteria

1) Pregnant, nursing women
2) Taking part in another test
3) Allergy to the test foods
4) Have a history of serious liver disorder, kidney disorder, heart disease
5) Taking medicines likely to affect the test results (ex. diabetes therapeutics)
6) Taking foods likely to affect the test results regularly (ex. indicating to reduce blood sugar level)
7) Those who were pointed out that blood glucose levels were higher in the past
8) Those who visit the hospital on a regular basis with some illness, and take medicines
9) Alcohol addicts
10) Having a history of hepatitis, or suffering from hepatitis presently
11) Arrhythmia and severe anemia
12) Taking blood coagulation inhibitor (warfarin, etc.)
13) Having symptoms such as dizziness, lightheadedness, heart palpiation, headache, shortness of breath
14) Total blood collection volume within 3 months before this study was 400 mL or more, or total blood collection volume within 2 months was 200 mL or more
15) A fasting blood glucose level was over 101 mg / dL at a medical examination within one year

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Koikeda

Organization

Shiba Palace Clinic

Division name

The director

Zip code


Address

1-9-10, Hamamatsu-cho, Minato-ku, Tokyo-to, 105-0013, Japan

TEL

+81-3-5408-1599

Email

jimukyoku@mail.souken-r.com


Public contact

Name of contact person

1st name
Middle name
Last name Shinichi Fukuda

Organization

Ezaki Glico Co., Ltd.

Division name

R&D Laboratory

Zip code


Address

4-6-5, Utajima Nishiyodogawa-ku, Osaka, 555-8502, Japan

TEL

+81-6-6477-8793

Homepage URL


Email

shinichi.fukuda@glico.com


Sponsor or person

Institute

Shiba Palace Clinic

Institute

Department

Personal name



Funding Source

Organization

Ezaki Glico Co., Ltd.
Research funds obtained from Ezaki Glico Co., Ltd. are received by SOUKEN SOUKEN 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


Address


Tel


Email



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

Shiba Palace Clinic


Other administrative information

Date of disclosure of the study information

2018 Year 02 Month 07 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

No longer recruiting

Date of protocol fixation

2018 Year 01 Month 17 Day

Date of IRB


Anticipated trial start date

2018 Year 02 Month 23 Day

Last follow-up date

2018 Year 08 Month 10 Day

Date of closure to data entry

2018 Year 08 Month 10 Day

Date trial data considered complete

2018 Year 08 Month 31 Day

Date analysis concluded

2018 Year 09 Month 30 Day


Other

Other related information



Management information

Registered date

2018 Year 02 Month 06 Day

Last modified on

2018 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=R000035415


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name