UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Portulaca Oleracea yeast extract on healthy volunteers in clinical trial.
Title of the study (Brief title)	Effect of Portulaca Oleracea yeast extract on healthy volunteers in clinical trial.
Region	Japan

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

Objectives
Narrative objectives1	This study is to evaluate the effect of test foods using Portulaca Oleracea as a raw material on humans, and evaluates mainly the influence on intestinal mucin and sIgA amount due to ingestion of slurrya.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intestinal mucin Intestinal sIgA
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	High dose Portulaca Oleracea yeast extract Subjects take 3 capsules after supper every day for 28 days.
Interventions/Control_2	Low dose Portulaca Oleracea yeast extract Subjects take 3 capsules after supper every day for 28 days.
Interventions/Control_3	Dextrin Subjects take 3 capsules after supper every day for 28 days.
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	19 years-old <=
Age-upper limit	37 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Male and female over the age of 16 2)Those who can attend the research site within the research period 3)Person who obtains consent in writing on participation of this research 4)Those who have not participated in other experiments within 3 months
Key exclusion criteria	Person who is in the hospital or medication under the basic disease (diabetes, heart disease, kidney disease, liver disease, hyponatremia, difficulty to treat hypertension, etc.) Person undergoing medication treatment. Extremely brief sleep (less than 5 hours a day) and long sleeping people (more than 10 hours a day). Those who live in the opposite direction day and night due to work or part-time job. Person who is undergoing excessive physical and mental stress. Individuals receiving treatment for autoimmune diseases, chronic inflammatory diseases, allergic diseases, cancer. Those who are accustomed to excessive smoking and excessive alcohol intake, and those with extremely irregular eating habits. Persons who have remarkable abnormalities in blood pressure, blood test, urinalysis, etc. Persons who overdosed the following items over ordinary meals. Caffeine (green tea, coffee), alcohol, carbohydrates, lipids, spices, capsaicin (foods rich in curry and chilies), lactic acid bacteria (yogurt), dietary fiber (brown rice, barley, soybean, burdock, carrots, sesame, potatoes, Seaweeds). Those who have undergone major surgery on the digestive system such as gastrectomy, gastrointestinal suture, intestinal resection. 400 mL blood donation within 12 weeks of starting the experiment, 200 mL blood donation within 4 weeks, donor ingredient donation within 2 weeks.
Target sample size	60

Research contact person
Name of lead principal investigator	Tatsuya Hisajima
Organization	Teikyo Heisei University
Division name	Faculty of Health Care
Address	2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo.
TEL	03-5843-3111
Email	s.tky0706@gmail.com

Public contact
Name of contact person	Tatsuya Hisajima
Organization	Teikyo Heisei University
Division name	Faculty of Health Care
Address	2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo.
TEL	03-5843-3111
Homepage URL
Email	s.tky0706@gmail.com

Sponsor
Institute	Teikyo Heisei University
Institute
Department

Funding Source
Organization	Amino Up Chemical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 11 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 04 Day
Anticipated trial start date	2017 Year 09 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 11 Month 07 Day
Last modified on	2017 Year 11 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034032