UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037071 |
|---|---|
| Receipt number | R000042243 |
| Scientific Title | A study for measurement of Glycemic Index (GI) of two kinds of foods in adult males and females |
| Date of disclosure of the study information | 2019/06/14 |
| Last modified on | 2020/02/28 15:35:08 |
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Basic information
Public title
A study for measurement of Glycemic Index (GI) of two kinds of foods in adult males and females
Acronym
A study for measurement of Glycemic Index (GI) of two kinds of foods
Scientific Title
A study for measurement of Glycemic Index (GI) of two kinds of foods in adult males and females
Scientific Title:Acronym
A study for measurement of Glycemic Index (GI) of two kinds of foods
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measure the GI values of two kinds of test foods
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)
Amount of change in blood glucose levels based on the blood glucose level before loading, Incremental area under the blood glucose response curve (IAUC), Area under the curve(AUC)
Amount of change in insulin levels based on the insulin level before loading, Incremental area under the insulin response curve (IAUC), Area under the curve(AUC)
Amount of change in questionnaire on Appetite(VAS-questionnaire) based on the appetite(VAS-questionnaire) before loading
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are 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 - a test food 1(single ingestion) - washout period - a test food 2(single ingestion)
Interventions/Control_2
Intake of a reference food(single ingestion) - washout period - a test food 2 (single ingestion) - washout period - a test food 1(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 have a difference within 25% in the incremental area under the curve (IAUC) of two preliminary tests
(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 routinely taking medicine or health food which may influence glucose metabolism
(2) Subjects whose BMI exceeds 30.0 kg/m2
(3) Subjects whose blood glucose level exceeds 126 mg/dL
(4) Subjects who have been pointed out as impaired glucose tolerance within 1 year
(5) Subjects who are suspected as impaired glucose tolerance in preliminary examination
(6) Subjects whose blood glucose level exceeds 110 mg/dL in glucometer on admission
(7) Subjects planned to travel abroad during the study period
(8) Subjects having possibilities for emerging allergy related to the current study
(9) Subjects who drink much alcohol
(10) Subjects who do excessive smoking
(11) Subjects who donated blood (blood donation etc.) exceeding 200 mL within 1 month or
400 mL within 4 months
(12) Subjects who have under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease)
(13) Subjects who have under treatment (e.g.,adiposity,hyperlipidemia, hypertension) that affects the evaluation of this study or medical history of serious illness for medication
(14) Subjects whose values of physical measurement, physical examination and clinical laboratory are significantly different from the reference range
(15) Subjects who may be pregnant or are pregnant, breastfeeding, or those who desire pregnancy during the study period
(16) Subjects who have participated in other clinical study within the last one month or have plan to participate other clinical studies
(17) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(18) Subjects who are judged as ineligible by the clinical investigator
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Fumitoshi |
| Middle name | |
| Last name | Horie |
Organization
Aisei Hospital Ueno Clinic
Division name
Director, Surgical
Zip code
110-0015
Address
2-18-6, Higashiueno, Taitou-ku, Tokyo
TEL
03-3834-3518
cl-rece@aisei-byouin.or.jp
Public contact
Name of contact person
| 1st name | Kunihiko |
| Middle name | |
| Last name | Wasaki |
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
k.wasaki@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
Aisei Hospital Ueno Clinic Research Ethics Committee
Address
2-18-6, Higashiueno, Taitou-ku, Tokyo
Tel
03-6455-0880
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
| 2019 | Year | 06 | Month | 14 | 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
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 14 | Day |
Last modified on
| 2020 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042243
