UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035802 |
|---|---|
| Receipt number | R000040781 |
| Scientific Title | Metabolic effects of barley intake |
| Date of disclosure of the study information | 2019/02/28 |
| Last modified on | 2022/09/09 17:23:28 |
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Basic information
Public title
Metabolic effects of barley intake
Acronym
Metabolic effects of barley intake
Scientific Title
Metabolic effects of barley intake
Scientific Title:Acronym
Metabolic effects of barley intake
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the changes of blood glucose level after barley intake
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in blood glucose level up to 120 minutes after ingestion
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
To intake 1 pack of barley rice
Interventions/Control_2
To intake 1 pack of rice
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) healthy adults
2) male and female
3) 20-80 years old
4) informed consent
Key exclusion criteria
1) Persons who develop an allergic reaction to barley
2) Those who have gastrointestinal disorder, or who routinely have diarrhea and feces close to liquid state
3) Person under taking medication for treating diabetes
4) Persons with severe illness
5) Participating in this research, persons who can not obtain written consent based on their own free will
6) Others who have judged that the research director is inappropriate as the subject
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroya |
| Middle name | |
| Last name | Hidaka |
Organization
Shinshu University School of Medicine
Division name
School of Health Sciences
Zip code
390-8621
Address
Asahi 3-1-1, Matsumoto, Nagano pref., 390-8621, Japan
TEL
0263-37-2368
hiroyan@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshihiko |
| Middle name | |
| Last name | Ikegami |
Organization
Shinshu University School of Medicine
Division name
School of Health Sciences
Zip code
390-8621
Address
Asahi 3-1-1, Matsumoto, Nagano pref., 390-8621, Japan
TEL
0263-37-3507
Homepage URL
tikegami@shinshu-u.ac.jp
Sponsor or person
Institute
Nagano Prefecture Next-generation Health Care Industry Council
Institute
Department
Personal name
Funding Source
Organization
Ministry of Agriculture, Forestry and Fisheries, Food Industry Affairs Bureau.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University School of Medicine
Address
Asahi 3-1-1, Matsumoto, Nagano
Tel
0263-37-2572
mdrinri@shinshu-u.ac.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
| 2019 | Year | 02 | Month | 28 | 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
| 2019 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 07 | Day |
Last modified on
| 2022 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040781
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
