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Soluble fiber intake at a dose approved by the US Food and Drug Administration for a claim of health benefits: serum lipid risk factors for cardiovascular disease assessed in a randomized controlled crossover trial.

BACKGROUND: The US Food and Drug Administration (FDA) approved health claims for 2 dietary fibers, beta-glucan (0.75 g/serving) and psyllium (1.78 g/serving), on the assumption that 4 servings/d would reduce cardiovascular disease risk. OBJECTIVE: We assessed the efficacy of this dose of fibers in reducing serum lipid risk factors for cardiovascular disease. DESIGN: Sixty-eight hyperlipidemic adults consumed a test (high-fiber) and a control low-fat (25% of energy), low-cholesterol (<150 mg/d) diet for 1 mo each in a randomized crossover study. The high-fiber diet included 4 servings/d of foods containing beta-glucan or psyllium that delivered 8 g/d more soluble fiber than did similar, unsupplemented foods in the control diet. Fasting blood samples and blood pressure readings were obtained at baseline and weeks 2 and 4, and the subjects' weight was monitored weekly. RESULTS: Compared with the control diet, the high-fiber diet reduced total cholesterol (2.1 +/- 0.7%; P = 0.003), total:HDL cholesterol (2.9 +/- 0.8%; P = 0.001), LDL:HDL cholesterol (2.4 +/- 1.0%; P = 0.015), and apolipoprotein B:A-I (1.4 +/- 0.8%; P = 0.076). Applying the Framingham cardiovascular disease risk equation to the data confirmed a reduction in risk of 4.2 +/- 1.4% (P = 0.003). Small reductions in blood pressure were found after both diets. The subjects reported no significant differences in palatability or gastrointestinal symptoms between the diets. CONCLUSIONS: The reduction in serum lipid risk factors for cardiovascular disease supports the FDA's approval of a health claim for a dietary fiber intake of 4 servings/d. Although relatively small in terms of patient treatment, the reduction in cardiovascular disease risk is likely to be significant on a population basis.

Adult↗

Fermentation of carbohydrate in rat ileal excreta is enhanced with cecal inocula compared with fecal inocula.

The differential fermentative capacities of microflora from two regions of the large bowel and how fermentation was altered by prior exposure of the microflora to the substrate to be fermented were studied using an in vitro fermentation system. Bacterial inocula were prepared from cecal contents and feces from three groups of rats fed purified diets containing 100 g/kg dietary fiber from canned peas or psyllium seed husk, or a nonpurified diet containing 170 g/kg dietary fiber. The substrate for all fermentations was ileal excreta from colectomized rats fed a purified diet containing 100 g/kg dietary fiber from canned peas. Anaerobic fermentations were conducted for 0, 3, 6, 12, 24, 48 and 96 h. Sugars of the unfermented polysaccharides were measured by gas chromatography following acid hydrolysis; disappearance was the measure of fermentation. Independent of inoculum source, > 90% of the starch and arabinose and 75% of the uronic acids, but < 30% of non-starch glucose (the measure of cellulose), were fermented by 24 h. Cecal inocula fermented arabinose and uronic acids more quickly (P < 0.05) and fermented more (P < 0.05) non-starch glucose than fecal inocula. Inocula adapted to psyllium seed husk fermented starch faster (P < 0.05) and non-starch glucose, arabinose and uronic acids more slowly (P < 0.05) than inocula adapted to peas or nonpurified diet. Bacterial efficiency of carbohydrate utilization, the increase in muramic acid/mole carbohydrate fermented, was greatest (P < 0.05) with cecal inocula adapted to peas. We conclude that using cecal microflora as the inoculum source provides a more accurate index of fermentation during transit through the large bowel and that noncellulosic and storage polysaccharides of the plant cell wall are utilized before cellulose.

Animals↗

Canine gastric emptying of fiber meals: influence of meal viscosity and antroduodenal motility.

Dietary fibers such as psyllium and guar gum have been shown to delay the gastric emptying of liquids and solids, presumably due to an increase in meal viscosity. For liquid test meals containing fats, delayed gastric emptying is associated with a reversal of the usual antral-to-duodenal contractile gradient. The present studies were performed to determine whether the gastric emptying of increasingly viscous psyllium and guar gum meals was associated with antroduodenal motility changes. Dogs were surgically fitted with mid-duodenal cannulas for the measurement of gastric emptying. Strain-gauge force transducers were used to monitor antral and duodenal contractile responses to the test meals. Low-viscosity fiber meals emptied from the stomach rapidly (E 1/2 approximately 10 min) compared with the high-viscosity meals (E 1/2 approximately 40 min). None of the test meals stimulated antral or duodenal motility despite differences in gastric emptying time. Other motor parameters such as the time of reappearance and the duration of the burst interval were also unchanged. We conclude a) as test meals' fiber content and viscosity increase, gastric emptying is slowed; and b) viscosity-related delays in gastric emptying are not due to an effect on postprandial antroduodenal motility.

Animals↗

Fruit and vegetable fiber fermentation by gut microflora from canines.

The objective of this study was to assess fermentability by canine gut microflora to include shortchain fatty acid (SCFA) production, organic matter (OM) disappearance, and gas production of vegetable and fruit fiber sources compared to fiber standards (psyllium, citrus pectin, and Solka Floc). Fiber sources included apple pomace, carrot pomace, flaxseed, fruit blend (mixture of peach, almond, nectarine, and plum), grape pomace, pea hulls, pistachio, and tomato pomace. Substrates were fermented in vitro for 4, 12, and 24 h with fecal flora obtained from three healthy dogs. Citrus pectin had the highest OM disappearance, SCFA production, and gas production at all times of fermentation; psyllium was intermediate and Solka Floc was lowest. A wide variation in fermentability was noted among the vegetable and fruit fiber sources. Apple pomace, carrot pomace, and flaxseed had the greatest fermentability as assessed by OM disappearance. Pea hulls and tomato pomace had intermediate OM disappearances, and fruit blend, grape pomace, and pistachio were poorly fermented. Carrot pomace produced the largest amounts of gas and SCFA. Apple pomace produced high concentrations of gas but intermediate concentrations of SCFA. Pea hulls and tomato pomace produced intermediate concentrations of gas and SCFA, whereas flaxseed, fruit blend, grape pomace, and pistachio produced low amounts of these fermentation products. For all substrates collectively, OM disappearance was highly correlated with both gas production (r2 = 0.782 and 0.723 for 12- and 24-h values, respectively) and SCFA production (r2 = 0.737 and 0.738 for 12- and 24-h values, respectively). In general, OM disappearance, gas production, and SCFA production were related to the insoluble:soluble fiber ratio in the samples; as the insoluble:soluble ratio decreased (increased soluble fiber), the OM disappearance, gas production, and SCFA production increased.

Animal Feed↗

[Common gastrointestinal symptoms and their effective and safe treatment].

The pharmacist is an important specialist in the selection of the drug when the patient comes for pharmacist's advice of how to alleviate common gastrointestinal symptoms. Of all drugs which can be effective in these situations, only three drugs (bismuth subsalicylate, psyllium, and docusate sodium) proved to be advantageous for self-medication. Bismuth subsalicylate (BSS) is much appreciated in the treatment of peptic ulcers where it not only covers the base of the ulcer but also eradicates Helicobacter pylori. Therefore this drug does not treat only the symptoms but the cause of the disease as well. Dyspepsia may also be effectively treated with BSS because of its strong and rapid protective effect on the gastric mucosa. Last but not least, the salicylate component of this substance and not bismuth alone is responsible for the elimination of diarrhoea in the so-called traveller's diarrhoea, as the salicylate decreases enhanced secretion of fluid in the colon. On the other hand, the natural fibre psyllium may effectively alleviate constipation, because it increases the volume and weight of stools as well as the transit time in the colon and facilitates defecation. Similarly, docusate sodium is a detergent agent which facilitates the entrance of water into the stool, which is then better and more easily pushed out from the large intestine.

Bismuth↗

Effect of long term treatment with hydrophilic colloid on serum lipids.

Thirteen patients with essential hyperlipoproteinaemia were treated over periods of 2--29 months with hydrophilic colloid made from Psyllium. Reduction of the increased serum cholesterol levels averaged 16.9 per cent, and the corresponding figure for the increased triglyceride levels was 52.0 per cent. The reduction of cholesterol and triglyceride was statistically significant (p less than 0.0025 and p less than 0.0005 respectively). No significant change in normal blood lipid levels was observed on administration of the Psyllium colloid.

Adult↗

The role of fiber in the treatment of hypercholesterolemia in children and adolescents.

The effect of adding water-soluble fiber to a diet low in total fat, saturated fat, and cholesterol to treat hypercholesterolemic children and adolescents with elevated plasma low-density lipoprotein (LDL) cholesterol levels was assessed. In more than a half-dozen studies, the effect of water-soluble fiber on the LDL cholesterol level ranged from no change to as high as a 23% decrease using oat bran, psyllium, or locust bean gum. The wide range of effects in these studies may be related to the quality of the dietary intervention or to different methods of randomization, blinding, dietary assessment, and laboratory measurement. For example, the addition of supplemented soluble fiber (psyllium) to a step 1 diet may provide additional lowering of LDL cholesterol of 10% to 15%. However, in children consuming the more stringent step 2 diet, the addition of water-soluble fiber may have less additional effects on LDL cholesterol. As recommended by the National Cholesterol Education Program Expert Panel on Blood Cholesterol Levels in Children and Adolescents, dietary therapy, that is, a diet low in total fat, saturated fat, and cholesterol, remains the cornerstone of treatment for children and adolescents with elevated LDL cholesterol levels. The use of foods high in water-soluble fiber that contain no cholesterol and are low in saturated fat remains a good choice in children following a step 1 or step 2 diet. Additional clinical trials in larger numbers of well-defined subjects will be needed to assess further the utility of adding water-soluble fiber supplements to the National Cholesterol Education Program step 1 or step 2 diets.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

The efficacy of an herbal medicine, Carmint, on the relief of abdominal pain and bloating in patients with irritable bowel syndrome: a pilot study.

Carmint contains total extracts of Melissa officinalis, Mentha spicata, and Coriandrum sativum, which have antispasmodic, carminative, and sedative effects. As abdominal pain/discomfort and bloating are commonly observed in patients with irritable bowel syndrome, we decided to evaluate the effectiveness of Carmint in relieving these symptoms in irritable bowel syndrome patients. We randomly assigned 32 irritable bowel syndrome patients to receive either Carmint or placebo, plus Loperamide or psyllium (based on their predominant bowel function), for 8 weeks. T-test analysis of the results showed that the severity and frequency of abdominal pain/discomfort were significantly lower in the Carmint group than the placebo group at the end of the treatment (P=0.016 and P=0.001, respectively), as were the severity and frequency of bloating (P=0.02 and P=0.002, respectively). This pilot study suggests that Carmint plus loperamide or Carmint plus psyllium (depending on the irritable bowel syndrome subtype) might be effective in these patients.

Abdominal Pain↗

Intestinal reactivity in allergic and nonallergic patients: an approach to determine the complexity of the mucosal reaction.

BACKGROUND: To determine whether inflammatory markers and mediators were released in response to different intestinal antigens, studies were performed in atopic patients allergic to birch, patients allergic to psyllium powder (ispaghula), and patients intolerant to milk. METHODS: Allergy to birch and psyllium powder was documented by the presence of circulating IgE antibodies and positive skin tests. Patients intolerant to milk had negative outcomes of radioallergosorbent tests and skin tests but positive results of double-blind, placebo-controlled tests. Challenge of the intestine with different antigens was achieved by perfusion of a jejunal segment occluded between balloons. Basal and antigen-activated release of mast cell/basophil and eosinophil products and of substances emanating from the plasma and interstitial fluid was compared in perfusate fluid from patients (n = 8) and matched healthy controls (n = 8). RESULTS: Perfusate levels of albumin and hyaluronan (previous name hyaluronic acid) were increased threefold to fivefold by antigen in all patients, but not in controls. Eosinophilic cationic protein increased in patients but also in ispaghula controls. Histamine was released in response to milk, but not in patients allergic to birch or ispaghula. Prostaglandin E2 increased in milk- and birch-sensitive patients. In response to ispaghula, however, it was released in both patients and controls. CONCLUSIONS: We conclude that subclinical intestinal challenge with antigen induces an increase in the appearance rate of albumin and hyaluronan in the intestinal lumen both in atopic patients (with target organs such as the lungs or nose and eyes) and in patients with intestinal intolerance to milk. These changes in permeation are similar to those reported from other organs such as the lung. They may reflect a common response in early phase I reactions that are either IgE-mediated or occur in response to food antigens without any obvious involvement of an IgE-mediated mechanism. Subclinical provocation with intestinal antigens should prove useful for further elucidation of mechanisms underlying intestinal mucosal reactions to exogenous stimuli.

Antigens↗

Development of sustained release gastroretentive drug delivery system for ofloxacin: in vitro and in vivo evaluation.

Sustained release (SR)-gastroretentive dosage forms (GRDF) enable prolonged and continuous input of the drug to the upper parts of the gastrointestinal (GI) tract and improve the bioavailability of medications that are characterized by a narrow absorption window. A new strategy is proposed for the development of gastroretentive dosage forms for ofloxacin preferably once daily. The design of the delivery system was based on the sustained release formulation, with floating and swelling features in order to prolong the gastric retention time of the drug delivery systems. Different polymers, such as psyllium husk, HPMC K100M, crospovidone and its combinations were tried in order to get the desired sustained release profile over a period of 24 h. Various formulations were evaluated for buoyancy lag time, duration of buoyancy, dimensional stability, drug content and in vitro drug release profile. It was found that dimensional stability of the formulation increases with the increasing psyllium husk concentration. It was also found that in vitro drug release rate increased with increasing amount of crospovidone due to the increased water uptake, and hence increased driving force for drug release. The optimized formulation was subjected to stability studies at different temperature and humidity conditions as per ICH guidelines. In vivo studies were carried out for the optimized formulation in 24 healthy human volunteers and the pharmacokinetic parameters of developed formulations were compared with the marketed once daily (Zanocin) formulation. Based on the in vivo performance in a parallel study design in healthy subjects, the developed formulation shows promise to be bioequivalent to the marketed product (Zanocin). The percent relative bioavailability of developed formulation was found to be 97.55%.

Absorption↗

Novel sustained release, swellable and bioadhesive gastroretentive drug delivery system for ofloxacin.

Oral sustained release gastroretentive dosage forms offer many advantages for drugs having absorption from upper gastrointestinal tract and improve the bioavailability of medications that are characterized by a narrow absorption window. A new gastroretentive sustained release delivery system was developed with floating, swellable and bioadhesive properties. All these properties were optimized and evaluated. Various release retarding polymers like psyllium husk, HPMC K100M and a swelling agent, crosspovidone in combinations were tried and optimized to get the release profile for 24 h. Formulations were evaluated for in vitro drug release profile, swelling characteristics and in vitro bioadhesion property. The in vitro drug release followed Higuchi kinetics and the drug release mechanism was found to be of anomalous or non-Fickian type. For the developed formulation, the value of n was found to be 0.5766 while for the marketed formulation the value was 0.5718 indicating the anomalous transport. The high water uptake leading to higher swelling of the tablet supported the anomalous release mechanism of ofloxacin. The similarity factor f2 was found to be 91.12 for the developed formulation indicating the release was similar to that of the marketed formulation (Zanocin OD). The swelling properties were increased with increasing crosspovidone concentration and contributed significantly in drug release from the tablet matrix. The bioadhesive property of the developed formulation was found to be significant (P < 0.005) in combination as compared to HPMC K100M and psyllium husk alone.

Administration, Oral↗

Monoclonal antibodies against the major allergen of Plantago lanceolata pollen, Pla l 1: affinity chromatography purification of the allergen and development of an ELISA method for Pla l 1 measurement.

BACKGROUND: Plantago lanceolata (English plantain) pollen is a relevant cause of pollinosis in temperate regions. The major allergen of this pollen, Pla l 1, is recognized by the specific IgE from more than 80% of plantain-sensitive patients. It displays significant sequence homology with the major olive-pollen allergen Ole e 1. The objective was to develop a monoclonal antibody-based ELISA to quantify Pla l 1, and to assess the correlation of Pla l 1 content with the biologic activity of plantain pollen extracts. We also aimed to establish the specificity of the monoclonal antibodies against the potentially cross-reactive allergen Ole e 1, and to investigate the presence of Pla l 1-like proteins in psyllium and melon that have been reported to cross-react with P. lanceolata pollen. METHODS: After fusion of myeloma cells with spleen cells from a BALB/c mouse, two Pla l 1-specific monoclonal antibodies secreting hybridomas were selected, and the antibodies characterized. One of them (2A10) was used as the capture antibody in an ELISA for Pla l 1 quantitation. An anti-P. lanceolata rabbit serum was used as the second antibody. Pla l 1 was purified by immunoaffinity chromatography and used as the standard in the assay. RESULTS: The ELISA developed was highly reproducible and sensitive, with a detection limit of 0.1 ng/ml, and a practical working range of 0.4-12 ng/ml. The specificity was demonstrated against a large battery of allergens, including Ole e 1. The concentration of Pla l 1 was measured in 19 extracts of P. lanceolata pollen, and a good correlation was observed between the Pla l 1 content and the allergenic activity of the extracts. Pla l 1 was not detected in psyllium or melon extracts. CONCLUSION: The results prove the usefulness of the Pla l 1-ELISA for the standardization of extracts of P. lanceolata pollen intended for clinical use.

Allergens↗

A novel inexpensive IV catheterization training model for paramedic students.

INTRODUCTION: Teaching paramedic students venipuncture and intravenous catheterization has traditionally relied on bulky, expensive phlebotomy models. A gelatin intravenous model (GIM) costing less than 50 cents is currently being used in the training of medical students and interns. The study objective was to evaluate paramedic students' perceptions of the GIM as a training tool. METHODS: GIMs are created using gelatin, psyllium, Penrose drains, food coloring, salt, and water. Penrose drains are filled with artificial blood composed of salt water and food coloring. The drains are placed in an aluminum pan with a base of hardening gelatin, with half-inch drains at the bottom of the pan and quarter-inch drains higher up in layers of mixed psyllium and gelatin to simulate deep and superficial veins respectively. A convenience, volunteer sample of 14 paramedic students who previously trained with traditional phlebotomy models each made two to five attempts at intravenous insertion using the GIM. Perceptions of the GIM were measured using a Likert scale (1, worst rating; 5, best rating). Means are reported. RESULTS: Study subjects rated ease of use at 4.17, realism at 4.07, and effectiveness in learning intravenous insertion at 4.28. GIM as a more effective teaching tool than the conventional rubber arm yielded a rating of 4.14. CONCLUSIONS: This study is limited by a small sample size, and further studies evaluating the GIMs construct and content validity are needed. Despite these limitations, given the GIMs simplicity and value, paramedic instructors may wish to consider implementation of this device in their training programs.

Adult↗

Components of fiber bind iron in vitro.

Interactions among fiber, inorganic iron, and substances known to chelate iron were examined in vitro. Cellulose, neutral and acid fractions of lignin, psyllium mucilage, and pectin were incubated with 59Fe SO4 at various pH's, in various concentrations, and in the presence or absence of known chelators of iron including ascorbate, citrate, cysteine, fructose, and EDTA. Insoluble components of fiber were tested in a precipitation-centrifugation system, soluble components were tested by equilibrium dialysis. Lignins and psyllium mucilage had the greatest capacity to bind ferrous iron under conditions that approximated those of the proximal intestine postprandially; cellulose and pectin were less potent. Dissociation constants of binding were similar for several components, suggesting the existence of comparable binding sites in different components of fiber. Citrate and EDTA inhibited the binding of iron markedly but other chelators were much less effective. These reactions among fiber, inorganic iron, and other constituents of food may influence the bioavailability of dietary iron and the simple systems described here offer a means of dissecting interactions that are complex in vivo.

Cellulose↗

Cholesterol-lowering effects of dietary fiber: a meta-analysis.

BACKGROUND: The effects of dietary soluble fibers on blood cholesterol are uncertain. OBJECTIVE: This meta-analysis of 67 controlled trials was performed to quantify the cholesterol-lowering effect of major dietary fibers. DESIGN: Least-squares regression analyses were used to test the effect on blood lipids of pectin, oat bran, guar gum, and psyllium. Independent variables were type and amount of soluble fiber, initial cholesterol concentration, and other important study characteristics. RESULTS: Soluble fiber, 2-10 g/d, was associated with small but significant decreases in total cholesterol [-0.045 mmol L(-1).g soluble fiber(-1) (95% CI: -0.054, -0.035)] and LDL cholesterol [-0.057 mmol.L(-1).g(-1) (95% CI: -0.070, -0.044)]. The effects on plasma lipids of soluble fiber from oat, psyllium, or pectin were not significantly different. We were unable to compare effects of guar because of the limited number of studies using 2-10 g/d. Triacylglycerols and HDL cholesterol were not significantly influenced by soluble fiber. Lipid changes were independent of study design, treatment length, and background dietary fat content. CONCLUSIONS: Various soluble fibers reduce total and LDL cholesterol by similar amounts. The effect is small within the practical range of intake. For example, 3 g soluble fiber from oats (3 servings of oatmeal, 28 g each) can decrease total and LDL cholesterol by approximately 0.13 mmol/L. Increasing soluble fiber can make only a small contribution to dietary therapy to lower cholesterol.

Adult↗

Dietary fiber supplementation and fecal bile acids, neutral steroids and divalent cations in rats.

Young adult rats were fed ad libitum for 4 wk on defined diets containing either no fiber, 10% levels of insoluble fiber sources [cellulose, wheat bran, alfalfa, mixed fibers (Fibyrax)], 5% levels of soluble fiber sources [pectin, guar gum, psyllium (Metamucil)] or 2% cholestyramine (Questran), a bile acid sequestrant. Fecal samples were obtained from paired rats over a 3-d period, were analyzed for neutral and acidic steroid levels and compositions and, together with the food, were assayed for divalent cations (Ca2+, Mg2+, Fe2+ and Zn2+). Animals in all groups were in balance for divalent cations, and there appeared to be no relationship between the extent of cation balance and the type of fiber fed. All insoluble fiber diets and the guar gum and psyllium diets resulted in significantly higher daily fecal mass and, in general, resulted in significant dilution of total fecal steroids. With the insoluble fibers, there was a general dilution of fecal neutral steroids, which was not apparent with the soluble fibers or cholestyramine. In addition, except for the pectin- and mixed fiber-containing diets, there was reduced bacterial conversion of the primary bile acids to secondary bile acids or metabolites.

Animals↗

Rat cecal inocula produce different patterns of short-chain fatty acids than fecal inocula in in vitro fermentations.

The effects of bacterial collection site, bacterial adaption to substrate and duration of fermentation on short-chain fatty acid (SCFA) production were studied using an in vitro fermentation system. Cecal and fecal inocula from rats fed purified diets containing 100 g/kg dietary fiber from canned peas or psyllium seed husk, or a nonpurified diet containing 170 g/kg dietary fiber fermented ileal excreta from colectomized rats fed a purified diet containing 100 g/kg dietary fiber from canned peas. The SCFA concentration, measured by gas chromatography, in anaerobic fermentations of 0, 3, 6, 12, 24, 48, 72 and 96 h, increased (P < 0.05) through 72 h. Compared with fecal inocula, cecal inocula produced SCFA at greater (P < 0.05) initial rates, more (P < 0.05) total SCFA and a greater (P < 0.05) proportion as n-butyrate. Inocula from rats fed the pea or nonpurified diets produced SCFA at greater (P < 0.05) molar proportions as acetate and less (P < 0.05) as propionate than inocula from rats fed psyllium seed husk at most time points. We conclude that collection site, adaptation of bacteria to the substrate to be fermented and duration of fermentation significantly influence the results of in vitro fermentation studies.

Animals↗

Effect of dietary fiber on pancreatic lipase activity in vitro.

Lipase activity was measured in buffer solutions and in human duodenal juice after incubation with wheat bran, psyllium, pectin, lignin, guar gum, and cellulose. In the presence of wheat bran and pectin, activity of both enzymes was inhibited, whereas psyllium reduced only lipase activity in duodenal juice. The influence was relatively small, it measured between 12.0 and 34.8% if 12.5 g/L of dietary fiber were tested. Maximal effect required about 60 min of incubation. Inhibitory activity was destroyed after 30-min treatment with hydrochloric acid (pH 1.5) or cooking (95 degrees C). Inhibitors in pectin were more heat-resistant. It is concluded that dietary fibers exert inhibitory actions on pancreatic lipase; in man unfavorable effects could occur in exocrine pancreatic insufficiency.

Animals↗