UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036141 |
|---|---|
| Receipt number | R000041171 |
| Scientific Title | Effects on postprandial blood glucose and triglyceride levels of confectionery made using Naked barley grown in Ehime prefecture for healthy subjects: crossover, placebo controlled randomized clinical trial |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2019/06/12 07:52:10 |
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Basic information
Public title
Effects on postprandial blood glucose and triglyceride levels of confectionery made using Naked barley grown in Ehime prefecture for healthy subjects: crossover, placebo controlled randomized clinical trial
Acronym
Effects on postprandial blood glucose triglyceride levels of confectionery made using Naked barley grown for healthy subjects: randomized clinical trial
Scientific Title
Effects on postprandial blood glucose and triglyceride levels of confectionery made using Naked barley grown in Ehime prefecture for healthy subjects: crossover, placebo controlled randomized clinical trial
Scientific Title:Acronym
Effects on postprandial blood glucose triglyceride levels of confectionery made using Naked barley grown for healthy subjects: randomized clinical trial
Region
| Japan |
Condition
Condition
Postprandial blood glucose and triglyceride levels
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to examine the effects on postprandial blood glucose and triglyceride levels of confectionery made using Naked barley grown in Ehime prefecture compared with confectionery without Naked barley for healthy subjects by crossover, placebo controlled randomized clinical trial
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postprandial blood glucose and triglyceride levels, and their area under the curve
Key secondary outcomes
1.Postprandial blood insulin level, and its area under the curve
2.Subjective appetite change after test meals
3. Gastrointestinal symptoms after test meals
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
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Firstly, the participants eat the test meal (bread 25g and butter 10g).
After eating test meal, the participants subsequently eat confectionery made using Naked barley (102g) in the intervention group.
Interventions/Control_2
Firstly, the participants eat the test meal (bread 25g and butter 10g).
After eating test meal, the participants subsequently eat placebo confectionery made using wheat (95g) in the control group.
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy men and women of 20 to 69 years of age at entry
Key exclusion criteria
1. Body mass index less than 18.5 kg / m 2, or, over 30 kg / m 2
2. Persons undergoing treatment for hypertension, dyslipidemia, diabetes, cancer, ischemic heart disease, cerebrovascular disease, chronic kidney disease, dementia, severe digestive system diseases
3. Women during pregnancy or lactation period
4. Food allergy of food to be provided (wheat, barley, peanuts, eggs)
5. The physician consider the individuals as inappropriate.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koutatsu Maruyama |
Organization
Ehime University
Division name
Laboratory of Community Health and Nutrition, Special Course of Food and Health Science Department of Bioscience, Graduate School of Agriculture
Zip code
Address
3-5-7 Tarumi, Matsuyama, Ehime
TEL
089-946-9960
maruyama.kotatsu.rt@ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koutatsu Maruyama |
Organization
Ehime University
Division name
Laboratory of Community Health and Nutrition, Special Course of Food and Health Science Department o
Zip code
Address
3-5-7 Tarumi, Matsuyama, Ehime
TEL
089-946-9960
Homepage URL
maruyama.kotatsu.rt@ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
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
| 2019 | Year | 04 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 21 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 09 | Day |
Last modified on
| 2019 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041171
