UMIN-CTR Clinical Trial

Public title

Effect of Portulaca Oleracea yeast extract on healthy volunteers in clinical trial.

Acronym

Effect of Portulaca Oleracea yeast extract on healthy volunteers in clinical trial.

Scientific Title

Effect of Portulaca Oleracea yeast extract on healthy volunteers in clinical trial.

Scientific Title:Acronym

Effect of Portulaca Oleracea yeast extract on healthy volunteers in clinical trial.

Region

Japan

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Intestinal mucin
Intestinal sIgA

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Tatsuya Hisajima

Organization

Teikyo Heisei University

Division name

Faculty of Health Care

Zip code

Address

2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo.

TEL

03-5843-3111

Email

s.tky0706@gmail.com

Name of contact person

1st name
Middle name
Last name	Tatsuya Hisajima

Organization

Teikyo Heisei University

Division name

Faculty of Health Care

Zip code

Address

2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo.

TEL

03-5843-3111

Homepage URL

Email

s.tky0706@gmail.com

Institute

Teikyo Heisei University

Institute

Department

Personal name

Organization

Amino Up Chemical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

11

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

08

Month

04

Day

Date of IRB

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

Other related information

Registered date

2017

Year

11

Month

07

Day

Last modified on

2017

Year

11

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034032