Phase 3
Completed N=80
Efficacy and Safety of Fermented Barley on Decrement of Body Fat in Obese Subjects
Overweight; Hyperlipidemia
Source: ClinicalTrials.gov NCT01402128 ↗
Enrolled (actual)
80
Serious AEs
—
Results posted
Dec 2012
Primary outcomePrimary: Changes in Body Fat Mass(kg) — 22.9; 24.3; 22.8; 24.1 kg
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Body Fat Mass(kg) |
22.9; 24.3; 22.8; 24.1 | — |
| PRIMARY Changes in Percent Body Fat(%) |
33.1; 33.7; 33.1; 33.7 | — |
| SECONDARY Changes in Visceral Adipose Tissue |
1250.7; 1296.1; 1140.3; 1165.7 | — |
| SECONDARY Changes in LDL-C (LDL Low Density Lipoprotein-cholesterol) |
141.7; 141.4; 141.7; 141.6 | — |
| SECONDARY Changes in HDL-C(High Density Lipoprotein-cholesterol) |
46.7; 47.1; 46.7; 46.1 | — |
| SECONDARY Changes in Total Cholesterol |
220.9; 220.0; 211.6; 210.9 | — |
| SECONDARY Changes in Triglyceride |
141.9; 133.0; 141.1; 133.2 | — |
| SECONDARY Changes in FFA(Free Fatty Acid) |
605.1; 591.1; 647.7; 644.4 | — |
| SECONDARY Changes in Apo-A1(Apolipoprotein A1) |
1.44; 1.42; 1.37; 1.36 | — |
| SECONDARY Changes in Apo-B(Apolipoprotein B) |
1.06; 1.05; 0.98; 0.99 | — |
| SECONDARY Changes in Subcutaneous Adipose Tissue |
2732.0; 2929.1; 2723.7; 2941.7 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01402128). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.