UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059764 |
|---|---|
| Receipt number | R000068231 |
| Scientific Title | The effect of honey intake on blood glucose responses |
| Date of disclosure of the study information | 2026/02/20 |
| Last modified on | 2025/11/11 17:04:55 |
* 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
The effect of honey intake on blood glucose responses
Acronym
The effect of honey intake on blood glucose responses
Scientific Title
The effect of honey intake on blood glucose responses
Scientific Title:Acronym
The effect of honey intake on blood glucose responses
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the change of blood glucose level by the test foods
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose level
Key secondary outcomes
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 test food 1- washout period - a test food 2
Dose: 250ml
Single ingestion
Interventions/Control_2
Intake of a test food 2- washout period - a test food 1
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females, aged 20 to 59 years at the time of providing consent
(2) Subjects with a BMI of less than 30 kg/m2
(3) Subjects who are able to provide fingertip blood sample (8 times/day for 3 observation periods)
(4) Subjects with normal blood glucose and HbA1c levels based on examinations in the past year, and who have not been advised to visit a hospital
(5) Subjects who have provided voluntary, written informed consent after fully understanding the details of the study
Key exclusion criteria
(1) Subjects who may develop allergies to the test food
(2) Subjects with a history of major surgery in the gastrointestinal tract, such as gastrectomy, gastrointestinal suture, or bowel resection
(3) Subjects who have chronic illness or disability in the liver, biliary tract, gastrointestinal tract, circulatory system, kidney, urinary system, psychiatric, nervous and hematological system
(4) Subjects who use health foods that contain ingredients that may affect the blood glucose level (unless they can discontinue use at least 1 week prior to the screening examination)
(5) Subjects who are routinely taking medicines known to affect blood glucose levels
(6) Subjects who are currently taking steroids, protease inhibitors or antipsychotics
(7) Subjects who are participating in another clinical trial at the time of screening
(8) Subjects who are pregnant, breast-feeding, or planning to become pregnant or breast-feeding during the study period
(9) Subjects who are unable to comply with the study requirements
(10) Subjects who are judged as ineligible for the subject of this study by investigator
Target sample size
28
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, 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, Japan
TEL
0868-54-1199
Homepage URL
yn2180@yamada-bee.com
Sponsor or person
Institute
Yamada Bee Company, Inc.
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
Yamada Bee Company Ethics Committee
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama, Japan
Tel
0868-54-1199
irb@yamada-bee.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
| 2026 | Year | 02 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 13 | Day |
Last modified on
| 2025 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068231
