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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000081
Receipt No. 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

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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
Email

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
Email zenymgt@yamanashi.ac.jp

Sponsor
Institute Department of Health Sciences
Interdisciplinary Graduate School of medicine and Engineering,
University of Ymanashi
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000134

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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