Effect of barley Intake on coronary heart disease risk factor, a randomized controlled trial.

UMIN ID: C000000081

Registered date:01/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: 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.
• Date of first enrollment: 2004/08/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Barley group was instructed about healthy foods choice, and take barley products for 12 weeks.
Control group was instructed about healthy foods choice.

Outcome(s)

• Primary Outcome: Outcome measures were plasma lipids, glucose, weight, and waist. End point was variable change form baseline at 12 weeks.
• Secondary Outcome: Comparison of mean change adjusted baseline value. Test for interaction.

Key inclusion & exclusion criteria

• Age minimum: 50years-old
• Age maximum: 70years-old
• Gender: Female
• Exclude criteria: cardiovascular disease; psychiatric problem; alcohol consumption >300 g/week; Usually consuming barley products.

Related Information

• Primary Sponsor: Department of Health Sciences Interdisciplinary Graduate School of medicine and Engineering, University of Ymanashi
• Secondary Sponsor: Yamanashi Koseiren Health Care Center. Third Department of Internal Medicine, Interdisciplinary Graduate School of Medicine and Engineering, University of Yamanashi
• Source(s) of Monetary Support: Hakubaku