UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035226 |
|---|---|
| Receipt number | R000040141 |
| Scientific Title | Clinical trial to evaluate Pholiota adiposa intake on serum glucose level after glucose load in healthy human. |
| Date of disclosure of the study information | 2018/12/12 |
| Last modified on | 2018/12/12 00:01:53 |
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Basic information
Public title
Clinical trial to evaluate Pholiota adiposa intake on serum glucose level after glucose load in healthy human.
Acronym
Clinical trial with Pholiota adiposa
Scientific Title
Clinical trial to evaluate Pholiota adiposa intake on serum glucose level after glucose load in healthy human.
Scientific Title:Acronym
Clinical trial with Pholiota adiposa
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the efficacy of Pholiota adiposa intake on serum glucose level after meal.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
glucose level (at min-0, min-30, min-60 and min-120)
Key secondary outcomes
AUC of glucose level
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Cooked Pholiota adipose,
25 g/meal, 50 g/meal,
Once a day
Interventions/Control_2
Placebo containing the three major nutrients 25 g/meal, 50 g/meal
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) Non smokers
(2) Persons who will generally be judged as healthy
(3) Persons who have never suffered from asthma
(4) Persons who have never developed any allegic reaction to medicines, foods, or other substances.
(5) Persons who will give written informed consent by theirselves
Key exclusion criteria
1) Persons who have any dietary supplements, quasi drugs or medicines which cause same or similar efficacy with the effect evaluated in this study.
(2) Persons who changed their habitats of supplements within 4 weeks.
(3) Persons who work in night shift or in day and night shift.
(4) Persons who have been treated their illness or prevention in a clinic at their informed consent
persons with their medical histories as follows: serious diseases of Sugar metabolism,lipid metabolismliver function, renal function, heart, circulatory, respiratory, endocrine system, immune system, or mental illness of the nervous system.
(6) Persons with the medical histories of alcoholism or drug dependence.
(7) Prsons who might be developed allergic reaction to foods.
(8) Persons who are pregnant, breast-feeding, or hope to be pregnant during the study period.
(9) Persons who had always participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device)
(10) Persons who will not be judged suitable to the participants by the investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichiro Ohnuki |
Organization
Kindai University
Division name
Department of Biological & Environmental
Zip code
Address
11-6, Kayanomori, Iizukacity, Fukuoka
TEL
0948-22-5655
ohnuki@fuk.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichiro Ohnuki |
Organization
Kindai University
Division name
Department of Biological & Environmental
Zip code
Address
11-6, Kayanomori, Iizukacity, Fukuoka
TEL
0948-22-5655
Homepage URL
ohnuki@fuk.kindai.ac.jp
Sponsor or person
Institute
Kinki University
Department of Biological & Environmental Chemistry
Faculty of Human-Oriented Science and Engineering
Institute
Department
Personal name
Funding Source
Organization
Judicial agricultural union Dream mash
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Faculty of Agriculture, Kyushu University
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
| 2018 | Year | 12 | Month | 12 | 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 | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 17 | 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
| 2018 | Year | 12 | Month | 12 | Day |
Last modified on
| 2018 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040141
