UMIN-CTR Clinical Trial

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