UMIN-CTR Clinical Trial

Basic information
Public title	The beneficial effect of the algal food intake on human gastrointestinal function
Acronym	The beneficial effect of the algal food intake on human gastrointestinal function
Scientific Title	The beneficial effect of the algal food intake on human gastrointestinal function
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	Intestinal bacterial Flora, putrefactive products, questionnaire

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
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 and <= 59 years at the time of informed consent (2) BMI <28kg/m2 (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 been exposed to ultraviolet rays beyond their daily life within the past 4 weeks. (8)Individuals who have irregular or disturbed life style such as night shifts. (9)Individuals who are receiving treatment at a medical institution or those who judged to be in the relevant condition requires treatment. (10)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. (11)Individuals who have history of alcohol and drug dependence. (12)Individuals who have participated in other clinical studies within the past 4 weeks and/or who plan to participate in the other clinical tests . (13)Individuals judged inappropriate for the study by the principal
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Madoka Middle name Last name Takahashi
Organization	KOBELCO ECO-SOULUTIONS CO.,LTD
Division name	Technical Develop Center
Zip code	651-2241
Address	1-1-4, Murotani, Nishi-ku, Kobe 651-2241
TEL	078-992-6957
Email	md.takahashi@kobelco-eco.co.jp

Public contact
Name of contact person	1st name Madoka Middle name Last name Takahashi
Organization	KOBELCO ECO-SOULUTIONS CO.,LTD
Division name	Technical Develop Center
Zip code	651-2241
Address	1-1-4, Murotani, Nishi-ku, Kobe 651-2241
TEL	078-992-6957
Homepage URL
Email	md.takahashi@kobelco-eco.co.jp

Sponsor
Institute	UNITIKA GARMENTS TECNOLOGY & RESEARCH LABORATORIES. LTD.
Institute
Department

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	Brain Care Clinic Ethics Review Committee
Address	Brain Care Clinic Ethics Review Committee
Tel	06-6882-1130
Email	ethics_board@drc-web.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

Other administrative information
Date of disclosure of the study information	2020 Year 10 Month 30 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	2019 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date	2019 Year 11 Month 06 Day
Last follow-up date	2019 Year 12 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 11 Month 05 Day
Last modified on	2019 Year 10 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043812