Ángela P. Calle

Therapeutic effects of psyllium in type 2 diabetic patients

Objective: The aim of this study was to evaluate the effects of psyllium in type 2 diabetic patients.Design: The study included three phases: phase 1 (1 week), phase 2 (treatment, 14 g fibre/day, 6 weeks) and phase 3 (4 weeks). At the end of each phase a clinical evaluation was performed after the ingestion of a test breakfast of 1824.2 kJ (436 kcal). Measurements included concentrations of blood glucose, insulin, fructosamine, GHbA1c, C-peptide and 24 h urinary glucose excretion. In addition, uric acid, cholesterol and several mineral and vitamin concentrations were also evaluated.Setting: The study was performed at the Department of Pharmacology, Toxicology and Nursing at the University of León (Spain).Subjects: Twenty type 2 diabetic patients (12 men and 8 women) participated in the study with a mean age of 67.4 y for men and 66 y for women. The mean body mass index of men was 28.2 kg/m2 and that of women 25.9 kg/m2.Results: Glucose absorption decreased significantly in the presence of psyllium (12.2%); this reduction is not associated with an important change in insulin levels (5%). GHbA1c, C-peptide and 24 h urinary glucose excretion decreased (3.8, 14.9 and 22.5%, respectively) during the treatment with fibre (no significant differences) as well as fructosamine (10.9%, significant differences). Psyllium also reduced total and LDL cholesterol (7.7 and 9.2%, respectively, significant differences), and uric acid (10%, significant difference). Minerals and vitamins did not show important changes, except sodium that increased significantly after psyllium administration.Conclusions: The results obtained indicate a beneficial therapeutic effect of psyllium (Plantaben®) in the metabolic control of type 2 diabetics as well as in lowering the risk of coronary heart disease. We also conclude that consumption of this fibre does not adversely affect either mineral or vitamin A and E concentrations. Finally, for a greater effectiveness, psyllium treatment should be individually evaluated.

Effects of ispaghula husk and guar gum on postprandial glucose and insulin concentrations in healthy subjects

Objective: The aim of this study was to evaluate, under the same experimental conditions and in the same subjects, the effects of ispaghula husk and guar gum on postprandial glucose and insulin concentrations in healthy female subjects.Design: An oral glucose load with and without fiber was administered in the morning after an overnight fast. The study of the fiber effect was planned according to a randomized and cross-over design.Setting: The study was performed at the Department of Pharmacology, Toxicology and Nursing at the University of León (Spain).Subjects: Ten healthy female volunteers aged 30–48 y with normal body mass indices participated in this study.Results: A significant decrease in mean serum insulin concentrations was observed from 30 to 90 min in the presence of both fibers. The area under the insulin curve was significantly reduced by 36.1% for ispaghula husk and 39.4% for guar gum. The area under the glucose curve was reduced by 11.1% (significant difference) for ispaghula husk and 2.6% for guar gum (no significant difference).Conclusions: According to the results obtained in this study, the administration of ispaghula husk may be beneficial due to its ability to reduce glucose postprandial concentration and especially insulin requirements. Individualization of the treatment would be advisable due to large individual variations observed in glycemic and insulinemic postprandial responses.European Journal of Clinical Nutrition (2001) 55, 235–243

Hydrosoluble fiber (Plantago ovata husk) and levodopa II: Experimental study of the pharmacokinetic interaction in the presence of carbidopa

Levodopa combined with carbidopa constitutes one of the most frequent medication in the treatment of Parkinsons disease. Plantago ovata husk (water-soluble fiber) improves levodopa absorption conditions, but when this drug is administered with carbidopa, fiber could reduce its effectiveness. The purpose of this study is to investigate whether the presence of P. ovata husk modifies in rabbits the bioavailability and other pharmacokinetic parameters of levodopa (20 mg/kg) when administered by the oral route with carbidopa (5 mg/kg). We have also studied whether pharmacokinetic modifications are fiber-dose dependent (100 and 400 mg/kg). When levodopa and carbidopa were administered with 100 mg/kg P. ovata husk, the value of AUC for levodopa diminishes 29.7% (sign, n=6, P<0.05) and Cmax 28.1% (sign, n=6, P<0.05) in relation to the values obtained when these drugs were administered without fiber. If the dose of fiber was 400 mg/kg, the decrease was smaller: 20.4% for AUC (no significant difference) and 24.6% for Cmax (sign, n=6, P<0.05), that may indicate an inhibitory action of AADC by the fiber or any of its partial hydrolysis products. On the other hand, since certain time on, levodopa concentrations are always higher in the groups that receive fiber: 210 min with 100 mg/kg and 150 min with 400 mg/kg. The administration of P. ovata husk with levodopa/carbidopa to patients with Parkinson disease could be beneficial and in particular in those patients who also suffer constipation due to an improvement of levodopa kinetic profile with higher final concentrations, a longer plasma half-life and lower Cmax.

Hydrosoluble fiber (Plantago ovata husk) and levodopa I: experimental study of the pharmacokinetic interaction.

Fiber therapy could be used in patients with Parkinson disease to reduce the symptoms of gastrointestinal disorders; however, it could interact with levodopa reducing its effectiveness. In this experimental study we have investigated whether the presence of Plantago ovata husk (water-soluble fiber) modifies in rabbits the bioavailability and other pharmacokinetic parameters of levodopa (20 mg/kg) when administered by the oral route at the same time. We have also studied whether pharmacokinetic modifications are fiber-dose dependent (100 and 400 mg/kg). The extent of levodopa absorbed when administering 100 mg/kg of fiber (AUC=43.4 mug min ml(-1)) is approximately the same as when levodopa is administered alone (AUC=47.1 microg min ml(-1)); however, Cmax is lower (1.04 versus 1.43 microg ml(-1)). Results obtained indicate that fiber at the higher dose increases the extent of levodopa absorbed (AUC=62.2 microg min ml(-1)), being the value of Cmax similar (1.46 microg ml(-1)). The value of tmax increases from 10 min when levodopa is administered alone to 20 min when the animals receive fiber. On the other hand, since certain time on, levodopa concentrations are always higher in the groups that receive fiber: 60 min with 100 mg/kg fiber and 20 min with 400 mg/kg fiber. Fiber also increases the mean residence time (MRT). P. ovata husk administration with levodopa could be beneficial, not only in patients with constipation, due to: lower adverse reactions (lower values of Cmax) and longer and more stable effects (higher final concentrations and more time in the body).

Influence of two dietary fibers in the oral bioavailability and other pharmacokinetic parameters of ethinyloestradiol.

Dietary fibers are widely used in hypoglycaemic, hypolipidemic, slimming diets. It is probable that their ingestion coincides with the oral administration of drugs and a modification of their pharmacokinetics can appear. In the present study, the influence of two soluble fibers (guar gum and psyllium) was evaluated on the pharmacokinetics of ethinyloestradiol (EE) when they were administered together to female rabbits via the oral route. Three groups of rabbits were used. All animals received 1 mg/kg of EE; this compound was administered alone in the control group and with 3.5 g of guar gum or psyllium in the other two groups. When guar gum was administered, there was a decrease in the extent of EE absorbed, but no change was observed in the rate of absorption. When psyllium was administered, the extent of EE absorbed increased slightly and the rate of absorption was slower.

Hypoglycemic and Hypolipidemic Potential of a High Fiber Diet in Healthy versus Diabetic Rabbits

The aim of this study was to investigate potential hypoglycaemic and hypolipidemic effects of Plantago ovata husk included in the diet, in healthy and diabetic rabbits. We also examined the effects of this fiber in other biochemical parameters. Two groups of 18 rabbits were used. The first group was fed with standard chow and the second with chow supplemented with Plantago ovata husk (3.5 mg/kg/day). On day 14 diabetes mellitus was induced by the intravenous administration of alloxan (80 mg/kg). After an oral glucose load (3 g), glucose, insulin, and other biochemical parameters were determined on day 14 (healthy rabbits) and on day 28 (diabetic rabbits). In healthy rabbits, fiber did not modify glucose or insulin levels but decreased significantly total cholesterol, LDL-cholesterol, atherogenic index, and glycosylated hemoglobin. In diabetic rabbits, fiber was more beneficial in mild diabetics than in severe diabetics with significant decreases in glucose levels and increases in insulin concentrations. In these animals fiber caused an important reduction in cholesterol, indicating a beneficial effect of Plantago ovata husk in diabetic rabbits. Although further studies in patients are necessary, we think that Plantago ovata husk offers interesting perspectives to be administered to patients with diabetes mellitus.

Effects of Plantago ovata Husk on Levodopa (with Carbidopa) Bioavailability in Rabbits with Autonomic Gastrointestinal Disorders

Gastrointestinal dysfunction is common in Parkinsons disease. Fiber therapy could be used to reduce the symptoms of gastrointestinal motility disorders. In a previous study, we showed that slowed gastrointestinal motility modified levodopa pharmacokinetics: area under the plasma concentration-time curve (AUC) and maximum plasma concentration (Cmax) decreased and the elimination was delayed. In this study, we evaluated whether or not the hydrosoluble fiber Plantago ovata husk is useful in improving levodopa pharmacokinetics in rabbits with autonomic gastrointestinal disorders induced by the administration of the anticholinergic biperiden. Levodopa + carbidopa (20:5 mg/kg), biperiden (100 μg/kg), and P. ovata husk (at two different doses: 100 and 400 mg/kg) were administered orally to rabbits for two periods of time (7 or 14 days). In all groups of animals, the AUC values were approximately 50% higher on the final day of treatment than on day 1. Cmax was also higher, with the greater increase at the 400 mg/kg dose of fiber, which resulted in a boost of approximately 35%. On day 1 of treatment and with both doses of fiber, AUC values were very similar to those obtained in previous work in rabbits with normal gastrointestinal motility, but the Cmax was lower. However, after 7 or 14 days, the AUC values were higher, but Cmax remained lower. The greatest differences were observed in plasma concentration before drug administration (Cmin), for which the highest increase was obtained with the dose of 400 mg/kg fiber on day 14 of treatment (349.8%). P. ovata husk could be beneficial in patients with Parkinsons disease because it regulates stool transit in the intestine and because it improves levodopa pharmacokinetics when gastrointestinal peristalsis is slowed. These changes could lead to a possible delay in the onset of dyskinesias and to changes in prognosis.