UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055728 |
|---|---|
| Receipt number | R000063684 |
| Scientific Title | Measurement study on Glycemic index (GI) of honey |
| Date of disclosure of the study information | 2024/10/10 |
| Last modified on | 2025/01/06 16:58:09 |
* 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
Measurement study on Glycemic index (GI) of honey
Acronym
Measurement study on Glycemic index (GI) of honey
Scientific Title
Measurement study on Glycemic index (GI) of honey
Scientific Title:Acronym
Measurement study on Glycemic index (GI) of honey
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure the glycemic index (GI) of the test food
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glycemic Index
Key secondary outcomes
Amount of change in blood glucose levels based on the blood glucose level before loading, Maximum blood glucose level (Cmax), Incremental area under the blood glucose response curve (IAUC), Area under the curve(AUC)
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of a glucose solution as reference - washout period - a test food 1- washout period - a test food 2- washout period - glucose solution as reference
Dose: 250ml
Single ingestion
Interventions/Control_2
Intake of a glucose solution as reference - washout period - a test food 2- washout period - a test food 1- washout period - glucose solution as reference
Dose: 250ml
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
| 49 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Japanese males and females aged between 20 and 49
(2) Subjects who are healthy
(3) Subjects who are able to be taken blood sample multiple times
(4) Subjects who fully understand this study and consent in this study with written
(5) Subjects with normal blood glucose and HbA1c levels in the past year and who have not been advised to visit a hospital
Key exclusion criteria
(1) Subjects who have Chronic illness or disability in the liver, biliary tract, gastrointestinal tract, circulatory system, respiratory system, kidney, urinary system, mental, nervous and blood system
(2) Subjects who are participating in other clinical trials or scheduled to participate in the trial or are less than three months after the end of the trial
(3) Subjects who are under visiting hospital, medication, treatment
(4) Subjects who may develop allergies to the test food
(5) Subjects with a history of major surgery in the gastrointestinal tract, such as gastrectomy, gastrointestinal suture, or intestinal resection
(6) Subjects who a pregnant, breast-feeding, and planning to become pregnant or breast-feeding
(7) Subjects who are unable to maintain a regular lifestyle
(8) Subjects whose normal alcohol consumption exceeds 500 mL of beer equivalent per day
(9) Subjects who are judged as ineligible for the subject of this study from doctor
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Takato |
| Middle name | |
| Last name | Nikaido |
Organization
Yamada Bee Company, Inc.
Division name
Functional research section, Institute for Bee Products & Health Science, R&D department
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama, 708-0393, Japan
TEL
0868-54-1199
tn2381@yamada-bee.com
Public contact
Name of contact person
| 1st name | Yukie |
| Middle name | |
| Last name | Nakagawa |
Organization
Yamada Bee Company, Inc.
Division name
Functional research section, Institute for Bee Products & Health Science, R&D department
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama, 708-0393, Japan
TEL
0868-54-1199
Homepage URL
yn2180@yamada-bee.com
Sponsor or person
Institute
SOUKEN Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Company, Inc.
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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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
| 2024 | Year | 10 | Month | 10 | 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
12
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
| 2024 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 11 | 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
| 2024 | Year | 10 | Month | 03 | Day |
Last modified on
| 2025 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063684
