UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055213 |
|---|---|
| Receipt number | R000063065 |
| Scientific Title | Safety Study of Long-term Intake of Acacia Honey in Healthy Subjects |
| Date of disclosure of the study information | 2024/08/10 |
| Last modified on | 2025/02/10 11:06:12 |
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Basic information
Public title
Safety Study of Long-term Intake of Acacia Honey in Healthy Subjects
Acronym
Safety Study of Long-term Intake of Acacia Honey in Healthy Subjects
Scientific Title
Safety Study of Long-term Intake of Acacia Honey in Healthy Subjects
Scientific Title:Acronym
Safety Study of Long-term Intake of Acacia Honey in Healthy Subjects
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety of long-term intake of acacia honey (15 g/day for 12 weeks) in healthy adult men and women.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events (medical interview)
General tests (BMI, blood pressure, pulse rate)
Hematological tests
Blood biochemical tests
Urinalysis
Diary
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Acacia Honey
Intake amount: 15 g/day
Intake duration: 84 days
Interventions/Control_2
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy Japanese subjects between the ages of 20 and 65 at the time of informed consent.
2) Subjects not receiving treatment with medications, therapies, or procedures for any reason, whether seasonal, chronic, or acute.
3) Subjects who have fully understood this clinical study and have provided written informed consent of their own free will.
4) Subjects with a BMI greater than 18.5 and less than 30.0.
*BMI = Weight (kg) / {Height (m)}^2*
5) Subjects who can refrain from excessive exercise during the clinical study period.
6) Subjects who can maintain a diet of three meals per day and avoid overeating and excessive drinking during the clinical study period.
7) Subjects who can understand and comply with the management instructions during the clinical study period.
8) Subjects deemed eligible by the principal investigator or equivalent based on a comprehensive assessment.
Key exclusion criteria
1) Subjects with diseases of the gastrointestinal tract, liver, kidneys, heart, or circulatory system that affect the absorption, distribution, metabolism, or excretion of the test food.
2) Subjects with a history of major surgery of the gastrointestinal tract, such as gastrectomy, gastrointestinal suture, or bowel resection (except polypectomy and appendectomy).
3) Subjects with a history of cerebrovascular disease (except asymptomatic lacunar infarction).
4) Subjects with food allergies or hypersensitivity related to the test food, or with specific constitutions.
5) Subjects suspected of alcohol or drug abuse.
6) Subjects who have participated in another clinical trial or study within 84 days prior to the date of consent.
7) Subjects who have donated 400 mL of blood within 84 days, 200 mL of blood within 28 days, or received a component blood donation (plasma or platelets) within 14 days prior to the date of consent.
8) Subjects unable to refrain from consuming honey other than the test food during the study period.
9) Subjects with a postprandial glucose level of 140 mg/dL or higher at the time of SCR, or who have been diagnosed with diabetes by a physician at the time of application.
10) Subjects who wish to become pregnant or who are unable to use contraception during the clinical trial period.
11) Subjects who are breastfeeding or pregnant.
12) Subjects with irregular lifestyles due to night shifts or shift work.
13) Subjects who live with someone who is participating or planning to participate in the study.
14) Any other subjects deemed inappropriate for participation by the principal investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ayanori |
| Middle name | |
| Last name | Yamaki |
Organization
Yamada Bee Company, Inc.
Division name
Functional Ingredient 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
ay1255@yamada-bee.com
Public contact
Name of contact person
| 1st name | Akio |
| Middle name | |
| Last name | Ohkuma |
Organization
Research Center for Immunological Analysis, Inc.
Division name
-
Zip code
701-1221
Address
ORIC213, 5303, Haga, Kita-Ku, Okayama-shi, Okayama
TEL
08628609333
Homepage URL
info@menekibunseki.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
Research Center for Immunological Analysis, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamada Bee Company Ethics Committee
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 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
| 2024 | Year | 08 | 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
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 | 07 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 10 | 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 | 08 | Month | 10 | Day |
Last modified on
| 2025 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063065
