UMIN-CTR Clinical Trial

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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