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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041648
Receipt No. 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

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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
Email 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
Email mfujishima@sunchlorella.co.jp

Sponsor
Institute Sun Chlorella Corporation
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047535

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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