UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054342 |
|---|---|
| Receipt number | R000062017 |
| Scientific Title | Verification study on the effects of intake of fucoidan from Okinawamozuku on improvement of bowel movements - A randomized, double-blind, placebo-controlled, crossover study - |
| Date of disclosure of the study information | 2024/05/10 |
| Last modified on | 2025/11/18 08:47:58 |
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Basic information
Public title
Evaluation of the effects of intake of fucoidan from Okinawamozuku on improvement of bowel movements
Acronym
Evaluation of the effects of intake of fucoidan from Okinawamozuku on improvement of bowel movements
Scientific Title
Verification study on the effects of intake of fucoidan from Okinawamozuku on improvement of bowel movements
- A randomized, double-blind, placebo-controlled, crossover study -
Scientific Title:Acronym
Verification study on the effects of intake of fucoidan from Okinawamozuku on improvement of bowel movements
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the efficacy of fucoidan from Okinawamozuku in improving bowel movements in constipation-prone subjects by ingesting a placebo and the test food for 2 weeks each
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation survey (frequency of defecations)
Key secondary outcomes
Defecation survey (days of defecation, amount of defecation, fecal properties (hardness, color, odor), and feeling after defecation)
Daily log of life and physical condition
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
Daily intake a placebo capsule containing sucrose powder for 14 days, after washout period for 14 days, daily intake a test capsule containing fucoidan from Okinawamozuku for 14 days
Interventions/Control_2
Daily intake a test capsule containing fucoidan from Okinawamozuku for 14 days, after washout period for 14 days, daily intake a placebo capsule containing sucrose powder for 14 days
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Healthy Japanese women and men over 18 years old
2. Individuals who suffer from constipation
3. Subjects are able to consume seaweeds moderately in their diet
4. Subjects have been fully informed of the purpose and content of the study, have the capacity to consent,
and have voluntarily volunteered to participate in the study based on a thorough understanding of the study
and have given their written consent to participate in the study
5. Individuals do not have any exclusion criteria
Key exclusion criteria
1. Subjects who regularly use medicines (including herbal medicines) or supplements that affect bowel movements
2. Individuals with a history of serious hepatic disorder, renal disorder, or cardiac disease
3. Individuals with a history of other serious diseases
4. Individuals with food allergies (seaweed, caramel color, gelatin, etc.)
5. Subjects who prefer to eat high-fiber diets
6. Subjects who have difficulty in maintaining their lifestyle (diet, exercise, sleep, moderate alcohol consumption, etc.)
7. Individuals who have difficulty in filling in the subject's diary
8. Subjects who are pregnant or may be pregnant and those who are breast-feeding
9. Subjects are participating in other clinical trials at the time of the start of this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazunari |
| Middle name | |
| Last name | Tanaka |
Organization
University of Nagasaki
Division name
Local Area Cooperation Center
Zip code
851-2195
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan
TEL
095-813-5216
katanaka@sun.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Takahashi |
Organization
University of Nagasaki
Division name
Local Area Cooperation Center
Zip code
851-2195
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan
TEL
095-813-5216
Homepage URL
miyayu@sun.ac.jp
Sponsor or person
Institute
University of Nagasaki
Institute
Department
Personal name
Funding Source
Organization
Kyushu University
Faculty of Agriculture
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Nagasaki
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan
Tel
095-813-5216
katanaka@sun.ne.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
| 2024 | Year | 05 | 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
30
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 | 03 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 12 | 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 | 05 | Month | 09 | Day |
Last modified on
| 2025 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062017
