UMIN-CTR Clinical Trial

Basic information
Public title	Confirmatory study of the effect of ingestion of food containing seaweed extract on the intestinal environment
Acronym	Confirmatory study of the effect of ingestion of food containing seaweed extract on the intestinal environment
Scientific Title	Confirmatory study of the effect of ingestion of food containing seaweed extract on the intestinal environment
Scientific Title:Acronym	Confirmatory study of the effect of ingestion of food containing seaweed extract on the intestinal environment
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate the effect on the intestinal environment of healthy Japanese men and women aged 20 to 60 years by continuous intake of seaweed polyphenols for 4 weeks.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Stool test (intestinal flora)
Key secondary outcomes	(Secondary outcomes) Defecation survey form (defecation frequency, feces, stool odor, stool color, stool volume, discomfort after defecation), stool tests(decay product content in feces, ammonia content in feces, stool odor stool short-chain fatty acid) (Safety evaluation) Vital signs, physical measurement, blood biochemistry, hematology, urinalysis, adverse events

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	4-weeks intake of the test food
Interventions/Control_2	4-weeks intake of the placebo 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	Male and Female
Key inclusion criteria	1.Healthy Japanese men and women aged between 20 and 60 at the time of obtaining written informed consent 2.Subject with constipation tendency (4 bowel movements / week or less, excluding severe constipation) 3.Subject who can record the questionnaire on the web during the test period 4.Subject who can come to the venue on the designated inspection date and undergo inspection 5.Subject who has received sufficient explanation of the purpose and content of the research, have the ability to consent, voluntarily volunteered to participate in the examination after understanding it well, and agreed to participate in the examination in writing
Key exclusion criteria	1.Subject with a history of comorbidities in the digestive organs (excluding a history of cecum) 2.Subject who is taking medication or under medical treatment 3.Subject who is under exercise therapy or dietetic therapy 4.Subject who may develop allergies due to the test foods and who may cause serious allergic symptoms to other foods and medicines 5.Subject with current or history of drug dependence or alcohol dependence 6.Heavy drinkers 7.Subject who is out of the hospital due to mental disorders (depression, etc.) or sleep disorders, or who have a history of mental illness in the past 8.Subject with irregular life rhythms due to night shifts or shift work 9.Subject with extremely irregular lifestyle habits such as eating and sleeping 10.Subject who has an extremely unbalanced diet 11.Subject who has difficulty in taking the full amount of the prescribed diet 12.Serious diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), renal disease, heart disease, thyroid disease, adrenal disease, and other serious current or past diseases such as metabolic disease those who have 13.Subject who uses health foods, supplements, and medicines that have an intestinal regulating effect 14.Subject who has participated in other clinical trials (research) within 3 months from the date of consent acquisition or who plan to participate in other clinical trials (research) during the trial period 15.Subject who has collected 200 mL of blood or donated more than 400 mL of blood within 3 months from the date of consent acquisition 16.Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating 17.Subject who has a smoking habit 18.Subject who has difficulty observing records on various survey forms 19.Subject who is judged as an inappropriate candidate according to the screening data 20.Subject who is considered as an inappropriate candidate by the doctor in charge
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Zip code	108-0014
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Email	ochitani@huma-rd.co.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Zip code	108-0014
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Homepage URL
Email	ochitani@huma-rd.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	RIKEN VITAMIN 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	NISHI-UMEDA Clinic for Asian Medical Collaboration Clinical Research Institutional Review Board
Address	West Umeda Building 3F 3-3-45 Umeda Kita-ku Osaka Japan,530-0001
Tel	06-4797-5660
Email	jimukyoku@amc-clinc.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	2021 Year 01 Month 08 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	32
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	2020 Year 11 Month 20 Day
Date of IRB	2020 Year 11 Month 26 Day
Anticipated trial start date	2020 Year 11 Month 27 Day
Last follow-up date	2021 Year 04 Month 21 Day
Date of closure to data entry	2021 Year 05 Month 18 Day
Date trial data considered complete	2021 Year 05 Month 31 Day
Date analysis concluded	2021 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date	2020 Year 11 Month 27 Day
Last modified on	2021 Year 08 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048546