UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039201 |
|---|---|
| Receipt number | R000044157 |
| Scientific Title | The exploratory research on improvements in the gastrointestinal function of the algae food intake a randomized, double-blind, placebo-controlled, parallel-group study |
| Date of disclosure of the study information | 2020/12/01 |
| Last modified on | 2020/01/20 11:05:32 |
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Basic information
Public title
The exploratory research on improvements in the gastrointestinal function of the algae food intake
a randomized, double-blind, placebo-controlled, parallel-group study
Acronym
The beneficial effect of the algal food intake on human gastrointestinal function
Scientific Title
The exploratory research on improvements in the gastrointestinal function of the algae food intake
a randomized, double-blind, placebo-controlled, parallel-group study
Scientific Title:Acronym
The beneficial effect of the algal food intake on human gastrointestinal function
Region
| Japan |
Condition
Condition
Healthy individual
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to investigate the efficacy of the intake of the algae food
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bowel Survey
Key secondary outcomes
questionnaire
salivary sIgA concentration
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
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
algal food
Interventions/Control_2
placebo control food
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
Key inclusion criteria
(1) Japanese, adult, male subjects aged =>20 years at the time of informed consent
(2) It is less than 25 more than BMI18.
(3) Individuals who has trends of diahhrea.
(4)Individuals who are healthy and are not suffered from a chronic malady.
(5)Those from whom a written consent can be obtained on a voluntary basis.
Key exclusion criteria
(1)Individuals using medical products.
(2)Individuals who are prone to allergies for foods.
(3)Individuals who uses commercially available drug or a quasi-drugs, for the prevention and treatment of diarrhea with abdominal pain and abdominal discomfort, on a daily basis.
(4)Individuals who have a serious disease history or current medical history
(5)Individuals with serious anemia.
(6)Individuals who changed health food within the past 4 weeks or who started using it newly.
(7)Individuals who have irregular or disturbed life style such as night shifts.
(8)Individuals who are receiving treatment at a medical institution or those who judged to be in the relevant condition requires treatment.
(9)Individuals who have the following medical history : severe diseases (such as sugar metabolism, lipid metabolism, liver function, renal function, heart, circulatory organs, respiratory organs, endocrine system, the nervous system), or psychiatric diseases.
(10)Individuals who have history of alcohol and drug dependence.
(11)Individuals who have participated in other clinical studies within the past 4 weeks and/or who plan to participate in the other clinical tests .
(12)Individuals judged inappropriate for the study by the principal
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Hiromu |
| Middle name | |
| Last name | Okazawa |
Organization
Tokyo University of Agriculture
Division name
Faculty of Regional Environment Science
Zip code
156-8502
Address
1-1-1Sakuragaoka, Setagaya-ku, Tokyo
TEL
03-5477-2685
h1okazaw@nodai.ac.jp
Public contact
Name of contact person
| 1st name | Hiromu |
| Middle name | |
| Last name | Okazawa |
Organization
Tokyo University of Agriculture
Division name
Faculty of Regional Environment Science
Zip code
156-8502
Address
1-1-1Sakuragaoka, Setagaya-ku, Tokyo
TEL
03-5477-2685
Homepage URL
h1okazaw@nodai.ac.jp
Sponsor or person
Institute
Tokyo University of Agriculture
Institute
Department
Personal name
Funding Source
Organization
KOBELCO ECO-SOULUTIONS CO.,LTD
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
Tokyo University of Agriculture
Address
1-1-1Sakuragaoka, Setagaya-ku, Tokyo
Tel
03-5477-2685
h1okazaw@nodai.ac.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
| 2020 | Year | 12 | Month | 01 | 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
| 2020 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 02 | Month | 19 | Day |
Last follow-up date
| 2020 | 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
| 2020 | Year | 01 | Month | 20 | Day |
Last modified on
| 2020 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044157
