UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041648 |
|---|---|
| Receipt number | R000047535 |
| Scientific Title | Effect of Chlorella pyrenoidosa on Defecation -A Randomized, Double-blind, Cross-over-Study- |
| Date of disclosure of the study information | 2020/09/02 |
| Last modified on | 2020/09/02 11:06:06 |
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Basic information
Public title
Effect of Chlorella pyrenoidosa on Defecation
Acronym
Effect of Chlorella pyrenoidosa on Defecation
Scientific Title
Effect of Chlorella pyrenoidosa on Defecation
-A Randomized, Double-blind, Cross-over-Study-
Scientific Title:Acronym
Effect of Chlorella pyrenoidosa on Defecation
-A Randomized, Double-blind, Cross-over-Study-
Region
| Japan |
Condition
Condition
Healthy adult woman
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of the Chlorella intake on bowel movement and on intestinal environment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation frequency
Key secondary outcomes
Fecal amount, Fecal metabolite,
Intestinal flora, Clinical blood test, serum folate
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
Chlorella 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
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
(1)Healty woman who are 20 or more to less than 60 years old
(2)Healthy Japanese subjects who defecate three to five times per week
(3) Subjects must be able to come to the designated facility on the scheduled date of the clinical test
(4)Subjects who are explained about the clinical test, show understanding of the test procedures, and obtain written consent from themselves in advance
Key exclusion criteria
(1) Subjects who are continuously receiving treatment with medicines
(2) Subjects who regularly takes food for specified health use, functional foods, health foods, etc. that may affect the test.
(3) Subjects who are pregnant (including subjects who may be pregnant) or lactating.
(4) Subjects who donate blood or collect 200 ml or more of whole blood from 4 weeks prior to the start of the clinical test.
(5) Subjects who collect 400 ml or more of whole blood from 16 weeks prior to the start of the clinical test.
(6) Subjects whose blood collection volume from the month 12 months prior to the start of the clinical test to the start of it, plus the total planned blood collection volume for the clinical test, exceeds 800 ml
(7) Subjects currently participate as test subjects in another clinical test or have participated in the test within 4 weeks
(8) Subjects with pain or bleeding during defecation
(9) Subjects who underwent laparotomy within 6 months of the test
(10) Subjects who took antibiotics within 6 months of the test
(11) Subjects who drink too much alcohol and smoke excessively.
(12) Subjects with extremely irregular eating habits, shift work or midnight shift
(13) Subjects who plan to change their lifestyle substantially during the test period
(14) Subjects who are chronically prone to diarrhea
(15) Subjects who falls under any of the following
(a) Subjects with heart, liver or kidney disease (including when it is a complication of another disease)
(b) Subjects with a history of cardiovascular disease
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Fujishima |
Organization
Sun Chlorella Corporation
Division name
Production&Development Department Research&Development Group
Zip code
600-8177
Address
369 Osaka-cho, Karasuma-dori Gojo-sagaru, Shimogyo-ku, Kyoto 600-8177 Japan
TEL
075-288-3010
mfujishima@sunchlorella.co.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Fujishima |
Organization
Sun Chlorella Corporation
Division name
Production&Development Department Research&Development Group
Zip code
600-8177
Address
369 Osaka-cho, Karasuma-dori Gojo-sagaru, Shimogyo-ku, Kyoto 600-8177 Japan
TEL
075-288-3010
Homepage URL
mfujishima@sunchlorella.co.jp
Sponsor or person
Institute
Sun Chlorella Corporation
Institute
Department
Personal name
Funding Source
Organization
Sun Chlorella Corporation
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Chiyoda Paramedical Care Clinic, Metabologenomics, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Chushin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.co.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
チヨダパラメディカルケアクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 02 | 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
40
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
| 2016 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 05 | Month | 23 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 02 | Day |
Last modified on
| 2020 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047535
| Research Plan | |
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| Registered date | File name |
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