Overweight; Hyperlipidemia Clinical Trial
Official title:
The Effect of Barley Beta-glucan on Serum Lipids and Body Weight
Barley, like oats, is a rich source of the soluble fibre β-glucan, which has been shown to significantly lower LDL-cholesterol (LDL-C). However, barley foods have been less widely studied.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | May 2011 |
| Est. primary completion date | October 2010 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 19 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - an age from 19 to 70 years, - a BMI(Body Mass Index) >23 kg/m^2, - an LDL-C(Low Density Lipoprotein-cholesterol) concentration between 110 and 250 mg/dL Exclusion Criteria: - they had heart disease, liver or kidney disease, food allergies, daily exercise habits, a body weight increase or decrease >10 kg in the previous 3 months, irregular lifestyle habits - they took medication and functional foods known to affect lipid metabolism. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Clinical Trial Center for Functional Foods; Chonbuk National University Hospital | Jeonju | Jeollabuk-do |
| Lead Sponsor | Collaborator |
|---|---|
| Chonbuk National University Hospital |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes in Body Fat Mass(kg) | Body fat mass(kg) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | Yes |
| Primary | Changes in Percent Body Fat(%) | Percent body fat(%) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | Yes |
| Secondary | Changes in Visceral Adipose Tissue | Visceral adipose tissue was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | Yes |
| Secondary | Changes in LDL-C (LDL Low Density Lipoprotein-cholesterol) | LDL-C (LDL Low Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | Yes |
| Secondary | Changes in HDL-C(High Density Lipoprotein-cholesterol) | HDL-C(High Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | Yes |
| Secondary | Changes in Total Cholesterol | Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | Yes |
| Secondary | Changes in Triglyceride | Triglyceride was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | Yes |
| Secondary | Changes in FFA(Free Fatty Acid) | FFA(free fatty acid) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | Yes |
| Secondary | Changes in Apo-A1(Apolipoprotein A1) | Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | Yes |
| Secondary | Changes in Apo-B(Apolipoprotein B) | Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | Yes |
| Secondary | Changes in Subcutaneous Adipose Tissue | Subcutaneous adipose tissue was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | Yes |