UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023675 |
|---|---|
| Receipt number | R000027267 |
| Scientific Title | The evaluation test of glucose tolerance change and intestinal environmental change by intake of barley |
| Date of disclosure of the study information | 2016/08/18 |
| Last modified on | 2020/10/05 17:55:02 |
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Basic information
Public title
The evaluation test of glucose tolerance change and intestinal environmental change by intake of barley
Acronym
The evaluation test of glucose tolerance change and intestinal environmental change by intake of barley
Scientific Title
The evaluation test of glucose tolerance change and intestinal environmental change by intake of barley
Scientific Title:Acronym
The evaluation test of glucose tolerance change and intestinal environmental change by intake of barley
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to investigate the effect of barley intake of glucose tolerance change and intestinal environmental change in adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area under the curve of blood glucose and blood insulin in glucose tolerance test during 2weeks and 4 weeks of consumption
Key secondary outcomes
1)Incremental area under the curve of blood glucose and blood insulin in glucose tolerance test during 2weeks and 4 weeks of consumption
2)Blood glucose and blood insulin in glucose tolerance test during 2weeks and 4 weeks of consumption
3)Improving effect of intestinal environment (bowel movement, intestinal microflora, intestinal metabolite) during 2weeks and 4 weeks of consumption
4)Questionnaire of physical feeling during 2weeks and 4 weeks of consumption
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test food intake for 4 weeks - Washout 4
weeks - Control food intake for 4 weeks
Interventions/Control_2
Control food intake for 4 weeks - Washout 4 weeks - Test food intake for 4 weeks
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
| 50 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Males and females aged 50 to 69 years old.
2) Subjects whose body mass index (BMI) is included between 18 kg/m2 to less than 25 kg/m2.
3)Subjects whose fasting blood glucose level is under 109 mg/dL.
4) Subjects who don't take fermented foods, dietary fibers and supplements regularly.
5) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.
Key exclusion criteria
1)Subjects who didn't undergo abdominal surgical operation within 6 month before test start.
2)Subjects who didn't take antibiotics for 1 month or more within 6 month before test start.
3)Subjects who have allergy to test food.
4)Smokers
5)Subjects whose consort or partner also participates to same clinical test.
6)Subjects who plan big change of lifestyle during test period.
7)Subjects with tendency of chronic diarrhea.
8)Subjects who considered unfitness for the test because of having previous and/or current medical history of serious disease of liver, kidney and heart.
9)Subjects who suspected chronic or serious infectious disease.
10)Premenopausal women.
11)Subjects who participated the other clinical test within 1 month before test start.
12)Subjects who donated over 200 mL blood and/or blood components within the last one month to the current study.
13)Males who donated over 400 mL blood within the last three month to the current study.
14)Females who donated over 400 mL blood within the last four month to the current study.
15) Males who will be collected over 1200 mL blood, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
16) Females who will be collected over 800 mL blood, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
17)Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Katsuhisa |
| Middle name | |
| Last name | Sakano |
Organization
CPCC Company Limited
Division name
Clinical Research Planning Department
Zip code
101-0047
Address
4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Plan Sales Department
Zip code
101-0047
Address
4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
MetaGen, Inc.
Hakubaku co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hakubaku co.,Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Chushin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.co.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 | 08 | Month | 18 | 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 | 07 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 19 | 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
| 2016 | Year | 08 | Month | 18 | Day |
Last modified on
| 2020 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027267
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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