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

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 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


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

Value
https://center6.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