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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031163
Receipt No. 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

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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
Institute Shiba Palace Clinic
Institute
Department

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
URL(English) https://upload.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


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