UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054919 |
|---|---|
| Receipt number | R000062269 |
| Scientific Title | Evaluation of the Effect of Honey Intake on Improving Bowel Movements in Individuals with a Tendency towards Constipation |
| Date of disclosure of the study information | 2024/07/09 |
| Last modified on | 2025/07/15 11:48:39 |
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Basic information
Public title
Evaluation of the Effect of Honey Intake on Improving Bowel Movements in Individuals with a Tendency towards Constipation
Acronym
Evaluation of the Effect of Honey Intake on Improving Bowel Movements in Individuals with a Tendency towards Constipation
Scientific Title
Evaluation of the Effect of Honey Intake on Improving Bowel Movements in Individuals with a Tendency towards Constipation
Scientific Title:Acronym
Evaluation of the Effect of Honey Intake on Improving Bowel Movements in Individuals with a Tendency towards Constipation
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of honey on bowel movements in constipation-prone adult men and women who consume 15 g of honey or placebo at breakfast each morning for 4 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of bowel movements per week
Key secondary outcomes
Quality of Life Questionnaire for Constipation (PAC-QOL)
Defecation Diary
-Number of days with bowel movements
-Stool volume
-Stool shape
-Stool color
-Smell of stool
-Breathing strength during defecation
-Sensation of residual feces
-Abdominal symptoms (pain or discomfort in the abdomen (excluding menstrual cramps))
Base
Study type
Interventional
Study design
Basic design
Parallel
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
functional food
Intake:15g/day
Ingesion:28days
Interventions/Control_2
Placebo food
Intake:15g/day
Ingesion:28days (Screening phase: 7days)
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy Japanese men and women between 20 and 65 years of age at the time of consent
2) Have 3 to 5 bowel movements per week
3) Subjects who regularly consume 3 meals a day.
4) Subjects who have fully understood the content of the study and have given their voluntary consent to participate in the study.
5) Subjects who are able to understand and comply with the study's administrative requirements during the study period.
Key exclusion criteria
Those who consume honey on a daily basis.
Those who are unable to refrain from consuming foods containing viable bacteria such as lactic acid bacteria and Bacillus subtilis natto, foods fortified with oligosaccharides and dietary fiber, health foods (including foods for specified health uses and foods with functional claims) that are said to be beneficial for improving constipation, and foods containing large amounts of sugar alcohols during the test period.
Persons who are regularly using medicines (e.g., laxatives), health foods, or supplements that may affect the test results, and who are unable to discontinue their use from the time of obtaining consent.
Persons who may show allergic symptoms to any of the ingredients in the test product.
Persons who have changed or plan to change their diet during the study period.
Persons who suffer from serious hepatic disorder, renal or cardiac disease, organ disorder, diabetes mellitus, or other serious diseases.
Those who have a history of major surgery on the gastrointestinal tract, such as gastrectomy, gastrointestinal suturing, or intestinal resection.
Those who consume excessive amounts of alcohol (more than 40 g/day in terms of pure alcohol content).
Those unable to maintain a regular lifestyle.
Pregnant or intending to become pregnant, or breast-feeding.
Those who are participating in other clinical trials or clinical studies during the study period.
Other subjects who are judged by the investigator to be inappropriate for participation in the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ayanori |
| Middle name | |
| Last name | Yamaki |
Organization
Functional Ingredient research section, Institute for Bee Products & Health Science
Division name
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, Japan
TEL
086-286-9333
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
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 | 07 | Month | 09 | 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
67
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
| 2024 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | 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 | 07 | Month | 09 | Day |
Last modified on
| 2025 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062269
