UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029857 |
|---|---|
| Receipt number | R000034032 |
| Scientific Title | Effect of Portulaca Oleracea yeast extract on healthy volunteers in clinical trial. |
| Date of disclosure of the study information | 2017/11/07 |
| Last modified on | 2017/11/07 11:48:28 |
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Basic information
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
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
| 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
s.tky0706@gmail.com
Public contact
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
s.tky0706@gmail.com
Sponsor or person
Institute
Teikyo Heisei University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034032
