UMIN-CTR Clinical Trial

Basic information
Public title	The effect of the algal food intake on bowel movement and on intestinal environment a randomized, double-blind, placebo-controlled, cross-over study
Acronym	The effect of the algal food intake on bowel movement and on intestinal environment
Scientific Title	The effect of the algal food intake on bowel movement and on intestinal environment a randomized, double-blind, placebo-controlled, cross-over study
Scientific Title:Acronym	The effect of the algal food intake on bowel movement and on intestinal environment
Region	Japan

Condition
Condition	Healthy young woman
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of the algal food 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 properties. Intestinal flora, Subjective evaluation (Sleep, Feeling of exhaustion, Feeling)

Base
Study type	Interventional

Study design
Basic design	Cross-over
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	18 years-old <=
Age-upper limit	29 years-old >=
Gender	Female
Key inclusion criteria	(1)Healty woman who are 18 or more to less than 29 years old (2)Healthy Japanese subjects who defecate three to five times per week (3)Healty Japanese subjects who do not have major changes in the living environment during the experiment
Key exclusion criteria	(1)Individuals who has treatment or history of malignant tumor, heart failure, myocardial infarction, psychiatric disorder. (2)Individuals who is being treated for arrhythmia, liver disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes, erectile dysfunction, thyroid disorder. (3)Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily (4)Individuals who intake algal food. (5)Subjects who are currently taking medications (including herbal medicines) and dietary supplements (6)Subjects who are allergic to medicines and/or the test food related (7)Subjects who are pregnant, breast-feeding, or planning to become pregnant (8)Individuals who have participated in other clinical studies within the past 1 month. (9)Individuals judged inappropriate for the study by the principal
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiramatsu Satoko
Organization	Okayama Prefectural University
Division name	Faculty of Health and Welfare Science
Zip code
Address	111 Kuboki, Soja-shi, Okayama, 719-1197, Japan
TEL	0866-94-2111
Email	shiramatsu@fhw.oka-pu.ac.jp

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

Sponsor
Institute	Okayama Prefectural University
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
Address
Tel
Email

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 01 Month 10 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	Completed
Date of protocol fixation	2018 Year 11 Month 22 Day
Date of IRB	2018 Year 11 Month 22 Day
Anticipated trial start date	2019 Year 01 Month 23 Day
Last follow-up date	2019 Year 04 Month 18 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 01 Month 15 Day
Last modified on	2020 Year 04 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040498