UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000081 |
|---|---|
| Receipt number | R000000134 |
| Scientific Title | Effect of barley Intake on coronary heart disease risk factor, a randomized controlled trial. |
| Date of disclosure of the study information | 2005/09/01 |
| Last modified on | 2005/08/27 12:51:46 |
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Basic information
Public title
Effect of barley Intake on coronary heart disease risk factor, a randomized controlled trial.
Acronym
Effect of barley Intake on coronary heart disease risk factor, a randomized controlled trial.
Scientific Title
Effect of barley Intake on coronary heart disease risk factor, a randomized controlled trial.
Scientific Title:Acronym
Effect of barley Intake on coronary heart disease risk factor, a randomized controlled trial.
Region
| Japan |
Condition
Condition
Women of aged 50 to 70 years, plasma total cholesterol of 220-280mg/dL, HbA1c of 5.5-6.5%, and without medication for hypertension, hyperlipidemia, and diabetes mellitus.
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To assess the effect of barley intake on coronary heart disease risk factor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Outcome measures were plasma lipids, glucose, weight, and waist. End point was variable change form baseline at 12 weeks.
Key secondary outcomes
Comparison of mean change adjusted baseline value.
Test for interaction.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Barley group was instructed about healthy foods choice, and take barley products for 12 weeks.
Interventions/Control_2
Control group was instructed about healthy foods choice.
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
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
women
Outpatients of human dry dock
aged 50 to 70 years;
total cholesterol of 220 to 280 mg/dL;
hemoglobin A1c of 5.5 to 6.5%;
current non-smoker;
no current use of oral medication to treat hypertension, diabetes mellitus or dyslipidemia.
Key exclusion criteria
cardiovascular disease;
psychiatric problem;
alcohol consumption >300 g/week;
Usually consuming barley products.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Zentaro Yamagata |
Organization
Interdisciplinary Graduate School of medicine and Engineering,
University of Ymanashi
Division name
Department of Health Sciences
Zip code
Address
1110, Shimokato, Tamaho-cho, Nakakoma-gun, Yamanashi-ken Postal code 409-3898
TEL
055-273-9566
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Zentaro Yamagata |
Organization
Interdisciplinary Graduate School of medicine and Engineering, University of Ymanashi
Division name
Department of Health Sciences
Zip code
Address
1110, Shimokato, Tamaho-cho, Nakakoma-gun,
TEL
055-273-9566
Homepage URL
zenymgt@yamanashi.ac.jp
Sponsor or person
Institute
Department of Health Sciences
Interdisciplinary Graduate School of medicine and Engineering,
University of Ymanashi
Institute
Department
Personal name
Funding Source
Organization
Hakubaku
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Yamanashi Koseiren Health Care Center.
Third Department of Internal Medicine,
Interdisciplinary Graduate School of Medicine and Engineering, University of Yamanashi
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
| 2005 | Year | 09 | 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
Completed
Date of protocol fixation
| 2004 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2005 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2005 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2005 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2006 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 08 | Month | 27 | Day |
Last modified on
| 2005 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000134
