UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024624 |
|---|---|
| Receipt number | R000028331 |
| Scientific Title | Effects of barley intake, a pilot study |
| Date of disclosure of the study information | 2016/10/31 |
| Last modified on | 2022/09/09 17:19:01 |
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Basic information
Public title
Effects of barley intake, a pilot study
Acronym
Effects of barley intake
Scientific Title
Effects of barley intake, a pilot study
Scientific Title:Acronym
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 the lipid, sugar and protein metabolism and the enteral environment after barley intake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
four weeks later from intake initiation.
levels of serum lipids
Key secondary outcomes
levels of serum proteins, carbohydrates and minerals.
enteral environment
bowel habit
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Effects of barley intake in healthy volunteers for four weeks
Interventions/Control_2
Intake two meals of rice cooked with barley per day
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
| 35 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy adults
male and female
20-35 years old
informed consent
Key exclusion criteria
1) allergy for the barley
2) therapeutic drugs routinely
3) digestive system disease
4) diarrhea tendency
5) feces of almost a liquid state routinely
6) not agreement
7) others
Target sample size
30
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, 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, 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
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
| 2016 | Year | 10 | Month | 31 | 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
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 29 | 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=R000028331
