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Completed

NCT Number: NCT01402128

Efficacy and Safety of Fermented Barley on Decrement of Body Fat in Obese Subjects

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.

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Key information

Conditions

Overweight; Hyperlipidemia Body Weight Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 560-822, South Korea

About this study

This study investigated whether the supplementation of barley β-glucan is reduce the visceral fat as well as the serum low-density lipoprotein cholesterol (LDL-C) and total cholesterol (TC) in mildly hypercholesterolemic subjects. In a 12 week double-blind, controlled study, subjects were randomized to one of treatment group(3.0g/day as β-glucan) or placebo group.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Barley beta-glucan(3.0g)

Dietary Supplement

Barley beta-glucan(3.0g/day) for 12 weeks

Placebo

Dietary Supplement

Placebo for 12 weeks

Primary outcomes

  1. Changes in Body Fat Mass(kg)

    Time frame: 12 weeks

    Body fat mass(kg) was measured in study visit 1(0 week) and visit 3(12 week).

  2. Changes in Percent Body Fat(%)

    Time frame: 12 weeks

    Percent body fat(%) was measured in study visit 1(0 week) and visit 3(12 week).

Secondary outcomes

  1. Changes in Visceral Adipose Tissue

    Time frame: 12 weeks

    Visceral adipose tissue was measured in study visit 1(0 week) and visit 3(12 week).

  2. Changes in LDL-C (LDL Low Density Lipoprotein-cholesterol)

    Time frame: 12 weeks

    LDL-C (LDL Low Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).

  3. Changes in HDL-C(High Density Lipoprotein-cholesterol)

    Time frame: 12 weeks

    HDL-C(High Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).

  4. Changes in Total Cholesterol

    Time frame: 12 weeks

    Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).

  5. Changes in Triglyceride

    Time frame: 12 weeks

    Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).

  6. Changes in FFA(Free Fatty Acid)

    Time frame: 12 weeks

    FFA(free fatty acid) was measured in study visit 1(0 week) and visit 3(12 week).

  7. Changes in Apo-A1(Apolipoprotein A1)

    Time frame: 12 weeks

    Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week).

  8. Changes in Apo-B(Apolipoprotein B)

    Time frame: 12 weeks

    Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week).

  9. Changes in Subcutaneous Adipose Tissue

    Time frame: 12 weeks

    Subcutaneous adipose tissue was measured in study visit 1(0 week) and visit 3(12 week).

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study title

The Effect of Barley Beta-glucan on Serum Lipids and Body Weight

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Jul 26, 2011
Registry last updated
Dec 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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