Aim: to compare the effect of the administration of a mixture of fibres Plantago ovata husk and glucomannan on body weight-loss, satiety and lipid profile
Study design: randomized, parallel, double-blind, placebo-controlled clinical trial.
Subjects: 166 patients (22% men and 78% women) between the ages of 18 and 70 years who were overweight or obese (27 ‹ BMI › 35 kg/m2) with a high degree of motivation to achieve weight loss. Patients were given a mixed fibre dose (3 g Plantago ovata husk and 1 g glucomannan) twice (b.i.d. group) or three times daily (t.i.d. group) or placebo times daily or placebo for 16 weeks. Weight change was the primary efficacy endpoint. Satiety, dietary compliance, lipid profile, glucose tolerance, insulin resistance and high-sensitivity C-reactive protein were secondary endpoints.
Results: weight loss tended to be higher after both doses of fibre (-4,52 (SD 0,56) and -4,60 (SD 0,55) kg) than placebo (-0,79 (SD 0,58) kg); the differences in changesbetween groups were not statistically significant. Postprandial satiety increased in both fibre groups compared to the placebo. The differences between groups in LDL-cholesterol levels were significant (p = 0,03), with greater reductions in the two fibre-supplemented groups (0,38 (SD 0,10) and 0,24 (SD 0,09) mmol/l in the b.i.d. and t.i.d. groups v. -0,06 (SD 0,09) mmol/l in placebo group). A similar pattern was observed for changes in total cholesterol: HDL-cholesterol and HDL-cholesterol: LDL-cholesterol ratios. Interventions were well tolerated and had no effects on HDL-cholesterol, glucose and insulin concentrations, glucose tolerance or high-sensitivity C-reactive protein. No serious adverse event was reported during the study. No significant differences in total adverse events were observed betweengroups.
Authors’ conclusion: a 16-week dietary supplement of soluble fibre in overweight or obese patients was well tolerated, induced satiety and had beneficial effects on some cardio-vasculair diseases risk factors, the most important of which was a significant decrease in plasma LDL-cholesterol concentrations.