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The effects of a bulk laxative (Metamucil®) on fasting blood glucose, serum lipids and other variables in constipated patients with non-insulin dependent adult diabetes
Abstract
This study of the effect of Metamucil in non-insulin-dependent diabetics revealed similar results as previously reported after the administration of other gel-forming fibres. Hitherto, studies have been made on the effect of LDL and HDL with diverging results. In this study, HDL was not significantly reduced after four months of treatment. Bran is probably relatively equal to the bulk laxatives in the treatment of constipation, but apparently bran lacks the effect on lipid and carbohydrate metabolism produced by the gel-forming fibres. Metamucil, being a mucilloid agent, in this study was proved to possess a significant long-acting reducing effect on fasting blood glucose and serum cholesterol.
... Psyllium husk fiber is a viscous, mostly water-soluble fiber prepared by mechanical removal of the husk from blonde psyllium seed (Plantago ovata). Early or uncontrolled studies suggested that psyllium improved glycemic and lipid control in individuals with type 2 diabetes (1)(2)(3). Although a more recent and carefully controlled study reported reduced postprandial glucose and insulin concentrations with psyllium supplementation in type 2 diabetes (4), other studies found no effect on glycemic control (5) or an effect only when psyllium was sprinkled onto or incorporated into a cereal meal (6). ...
... After a 2-wk dietary stabilization phase, 34 of these men qualified for random assignment to treatment. The Human Investigation Subcommittee of the Effects of psyllium on glucose and serum lipid responses in men with type 2 diabetes and hypercholesterolemia [1][2][3] University of Kentucky reviewed and approved the study and informed consent was obtained from each subject. ...
Water-soluble dietary fibers decrease postprandial glucose concentrations and decrease serum cholesterol concentrations. This study examined the effects of administering psyllium to men with type 2 diabetes.
The objective was to evaluate the safety and effectiveness of psyllium husk fiber used adjunctively to a traditional diet for diabetes in the treatment of men with type 2 diabetes and mild-to-moderate hypercholesterolemia.
After a 2-wk dietary stabilization phase, 34 men with type 2 diabetes and mild-to-moderate hypercholesterolemia were randomly assigned to receive 5.1 g psyllium or cellulose placebo twice daily for 8 wk. Serum lipid and glycemic indexes were evaluated biweekly on an outpatient basis and at weeks 0 and 8 in a metabolic ward.
In the metabolic ward, the psyllium group showed significant improvements in glucose and lipid values compared with the placebo group. Serum total and LDL-cholesterol concentrations were 8.9% (P < 0.05) and 13.0% (P = 0.07) lower, respectively, in the psyllium than in the placebo group. All-day and postlunch postprandial glucose concentrations were 11.0% (P < 0.05) and 19.2% (P < 0.01) lower in the psyllium than in the placebo group. Both products were well tolerated, with no serious adverse events related to treatment reported in either group.
The addition of psyllium to a traditional diet for persons with diabetes is safe, is well tolerated, and improves glycemic and lipid control in men with type 2 diabetes and hypercholesterolemia.
... One of them was conducted in type 1 diabetic patients (Florholmen et al, 1982) and four in type 2 diabetic patients (Sartor et al, 1981;Pastors et al, 1991;Wolever et al, 1991;Anderson et al, 1999). Two more studies were performed in both healthy and type 2 diabetic volunteers (Fagerberg, 1982;Jarjis et al, 1984). The results obtained in these studies are controversial. ...
... Similar results were encountered by Florholmen et al (1982) in type 1 diabetic patients. Fagerberg (1982) reported that psyllium reduced fasting serum glucose concentration in type 2 diabetic patients. Pastors et al (1991) indicate that the use of psyllium reduces postprandial glucose and insulin elevations in type 2 diabetic patients and that this ®ber can produce a signi®cant reduction in glucose after a second meal. ...
To evaluate the influence of Ispaghula husk in the postprandial glucose concentrations in serum in healthy volunteers.
This study is divided in two assays and 7 healthy women with ages ranging from 35 to 45 years participated in both assays. Assay 1. Administration of 50 g of glucose dissolved in 125 ml of water (followed by other 150 ml of water). Assay 2. It was carried out one week later in the same women and conditions as assay 1 but adding 10.5 g of Ispaghula husk to the dissolution. In both assays, blood samples were obtained at 0, 10, 20, 30, 45, 60, 75, 90 and 120 minutes after administration and glucose concentration was determined in serum.
The value of the area under the mean glucose concentration-time curve obtained in assay 2 (in the presence of fiber) was a 13.6% lower than that obtained in assay 1 (significant difference, p < or = 0.05). Individual concentration-time curves obtained in assay 1 can be considered as normal in 4 of the 7 volunteers. Abnormalities observed in the other 3 curves were due to: her history of prediabetic in one of them (glucose concentration values over 180 mg/100 ml); diabetic patients in her family in other of them (2 values over 180 mg/100 ml) and hypoglycaemia in two of the volunteers. When we administered glucose with fiber in assay 2, in all cases, the maximum concentration reached was lower, the variations in glycaemia values were also lower along the different sampling times (peaks disappear or are less marked) and no hypoglycaemia appeared.
... One of them was conducted in type 1 diabetic patients (Florholmen et al, 1982) and four in type 2 diabetic patients (Sartor et al, 1981;Pastors et al, 1991;Wolever et al, 1991;Anderson et al, 1999). Two more studies were performed in both healthy and type 2 diabetic volunteers (Fagerberg, 1982;Jarjis et al, 1984). The results obtained in these studies are controversial. ...
... Similar results were encountered by Florholmen et al (1982) in type 1 diabetic patients. Fagerberg (1982) reported that psyllium reduced fasting serum glucose concentration in type 2 diabetic patients. Pastors et al (1991) indicate that the use of psyllium reduces postprandial glucose and insulin elevations in type 2 diabetic patients and that this ®ber can produce a signi®cant reduction in glucose after a second meal. ...
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.
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.
The study was performed at the Department of Pharmacology, Toxicology and Nursing at the University of León (Spain).
Ten healthy female volunteers aged 30-48 y with normal body mass indices participated in this study.
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).
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.
... All of these investigations were associated in one way or another with the product manufacturer. Additional studies have also indicated some cholesterol-lowering by psyllium in hypercholesterolemic individuals [32-37] or in diabetics [38-40]; however, much of this work is uncontrolled and some protocols have specifically excluded premenopausal women [33,38]. The association of cholesterol-lowering effects with psyllium may be weakened in some studies by the use of a supplement containing additional forms of soluble fibre [42] or by apparent differences in intake of calories [43-46], soluble fibre [25] or cholesterol [47] in control and treatment groups or periods. ...
... All of these investigations were associated in one way or another with the product manufacturer. Additional studies have also indicated some cholesterol-lowering by psyllium in hypercholesterolemic individuals [32-37] or in diabetics [38-40]; however, much of this work is uncontrolled and some protocols have specifically excluded premenopausal women [33,38]. The association of cholesterol-lowering effects with psyllium may be weakened in some studies by the use of a supplement containing additional forms of soluble fibre [42] or by apparent differences in intake of calories [43-46], soluble fibre [25] or cholesterol [47] in control and treatment groups or periods. ...
Reports of the use of psyllium, largely in hypercholesterolemic men, have suggested that it lowers serum cholesterol as a result of the binding of bile acids in the intestinal lumen. Widespread advertisements have claimed an association between the use of soluble fibre from psyllium seed husk and a reduced risk of coronary heart disease. Given the purported mechanism of cholesterol-lowering by psyllium, we hypothesized that there would be a greater effect when psyllium is taken with breakfast than when taken at bedtime. Secondarily, we expected to confirm a cholesterol-lowering effect of psyllium in subjects with "average" cholesterol levels.
Sixteen men and 47 women ranging in age from 18 to 77 years [mean 53 +/- 13] with LDL cholesterol levels that were normal or slightly elevated but acceptable for subjects at low risk of coronary artery disease were recruited from general gastroenterology and low risk lipid clinics. Following a one month dietary stabilization period, they received an average daily dose of 12.7 g of psyllium hydrophilic mucilloid, in randomized order, for 8 weeks in the morning and 8 weeks in the evening. Change from baseline was determined for serum total cholesterol, LDL, HDL and triglycerides.
Total cholesterol for the "AM first" group at baseline, 8 and 16 weeks was 5.76, 5.77 and 5.80 mmol/L and for the "PM first" group the corresponding values were 5.47, 5.61 and 5.57 mmol/L. No effect on any lipid parameter was demonstrated for the group as a whole or in any sub-group analysis.
The timing of psyllium administration had no effect on cholesterol-lowering and, in fact, no cholesterol-lowering was observed. Conclusions regarding the effectiveness of psyllium for the prevention of heart disease in the population at large may be premature.
... Eighteen studies described in 19 publications included patients with diabetes. [58][59][60][61][62][63][64][65][66][67][68][69][70][71][72][73][74][75][76] FDA considers evidence from studies in individuals already diagnosed with diabetes only if it is scientifically appropriate to extrapolate to individuals who do not have the disease. That is, the available scientific evidence must demonstrate (1) the mechanism(s) for the mitigation or treatment effects measured in the diseased populations are the same as the mechanism(s) for risk reduction effects in nondiseased populations; and (2) the substance affects these mechanisms in the same way in people with the disease and healthy people. ...
The US Food and Drug Administration (FDA) received a petition from a company requesting that FDA issue an authorized health claim for the relationship between psyllium husk and a reduced risk of type 2 diabetes. After an initial assessment of the available scientific evidence, FDA determined that significant scientific agreement was lacking for this substance-disease relationship, whereupon the company agreed to have its petition reviewed as a qualified health claim. This article describes the process FDA used in conducting an evidence-based review of the science underpinning the proposed claim and addresses certain safety issues associated with psyllium husk that FDA considered in its review of the petition. Of the 6 studies from which scientific conclusions could be drawn, as identified through FDA's review, psyllium husk significantly improved plasma glucose levels and insulin sensitivity in only 1 study. Therefore, FDA's enforcement discretion letter for this qualified health claim stated: "Psyllium husk may reduce the risk of type 2 diabetes, although the FDA has concluded that there is very little scientific evidence for this claim."
... 7,8,10,25 Effect of psyllium on glycemic control which showed an improvement in both FPG and HbA1c, is clinically meaningful which is comparable to the effect of many medications that are used to treat T2D, such as long term metformin therapy in the Diabetes Prevention program. 29 Of the studies 7,8,10,25,[30][31][32] that evaluated FPG in patients with T2D, all but one study 30 showed a significant improvement with the use of psyllium. Three 7,10,25 of the 4 7,30,10,25 studies that evaluated HbA1c showed significant improvement with the use of psyllium. ...
Background:
Both flaxseed and psyllium have previously been shown to reduce constipation symptoms, weight, glycemic and lipid levels, and we postulate that treatment with flaxseed and psyllium may have similar benefits.
Objective:
To compare constipation symptoms, weight, glycemia, and lipids in constipated patients with type 2 diabetes (T2D) who received baked flaxseed or psyllium versus those who received a placebo.
Methods:
In a single-blinded, randomized controlled trial, 77 constipated patients with T2D were randomized into three groups. Patients received either 10 g flaxseed or psyllium pre-mixed in cookies or placebo cookies twice per day for a total of 12 weeks. The constipation symptoms, body mass index (BMI), fasting plasma glucose (FPG), glycosylated hemoglobin (HbA1c), and lipid profile were determined at the beginning and end of 4, 8, and 12-week period. Constipation was assessed with the ROME III criteria score.
Results:
The flaxseed appear to be superior to psyllium for improving constipation symptoms, weight, glycemic, and lipid control. The change from baseline of constipation symptoms (P = 0.002), stool consistency (P < 0.001), weight (P < 0.001), BMI (P < 0.001), FPG (P = 0.004), cholesterol (P = 0.010), LDLC (P = 0.031), and cholesterol/HDLC ratio (P = 0.019), was significantly improved in both flaxseed and psyllium groups than in the placebo group. The compliance was good and no adverse effects were observed.
Conclusion:
Although both flaxseed and psyllium may decrease constipation symptoms, weight, glycemic and lipid levels, treatment with flaxseed appear to be superior to psyllium.
Trial registration:
Registered under Iranian Clinical Trials Identifier no. IRCT20110416006202N2.
... 7,8,10,25 Effect of psyllium on glycemic control which showed an improvement in both FPG and HbA1c, is clinically meaningful which is comparable to the effect of many medications that are used to treat T2D, such as long term metformin therapy in the Diabetes Prevention program. 29 Of the studies 7,8,10,25,[30][31][32] that evaluated FPG in patients with T2D, all but one study 30 showed a significant improvement with the use of psyllium. Three 7,10,25 of the 4 7,30,10,25 studies that evaluated HbA1c showed significant improvement with the use of psyllium. ...
Objective:
To compare the effects of baked psyllium supplementation versus those who received a placebo on constipation symptoms, body weight, glycemic and lipids control in patients with type 2 diabetes (T2D) and chronic constipation.
Methods:
In a single-blinded, randomized controlled trial, 51 patients with T2D and chronic constipation with body mass index (BMI) 20-47 kg/m2 received either 10 g of psyllium pre-mixed in cookies twice per day or placebo cookies for 12 weeks. Constipation symptoms, body mass index (BMI), fasting plasma glucose (FPG), glycosylated hemoglobin (HbA1c), and lipid profile were determined at the beginning and end of 4, 8, and 12-week period. Constipation was evaluated with a stool diary (ROME III).
Results:
The psyllium group showed improvement in constipation symptoms, body weight, glucose and lipid values compared with the baseline and the placebo group. Body weight and FPG decreased from baseline in the psyllium group (P < 0.001 and P = 0.056, respectively). The differences (95% CI) of absolute change of body weight (-2.0 (-3.0, -1.0) kg; P < 0.001), FPG (-13.6 (-24.3, -2.9) mg/dl; P = .040), and HbA1c (-1.7 (-2.9, -0.5)); P = 0.002) between the groups were statistically significant. Cholesterol (-21.5 (-25.6, -14.4); P < 0.001), triglycerides (-20.0 (-32.3, -7.7); P = 0.021) and constipation symptoms (1.5 (0.4, 2.3); P < 0.001) decreased in the psyllium group. The compliance was good and no adverse effects were observed.
Conclusion:
In patients with T2D and chronic constipation, psyllium supplementation decreased constipation symptoms, body weight, glycemic, cholesterol, and increased HDLC levels.
... Viscous soluble fibers have been shown to attenuate postprandial glucose and insulin responses, as well as reduce hunger feelings, in healthy subjects (Rigaud, Paycha, Meulemans, Merrouche, & Mignon, 1998;Sierra et al., 2001). In clinical studies of patients with type 2 diabetes, supplementing the diet with psyllium improves glycemic control in patients who are already on a highly restrictive diet (e.g., American Heart Association [AHA] Step 2) and taking oral hypoglycemic agents (Fagerberg, 1982;Gibb, Ramsey, Tse, & McRorie, 2011;Gupta, Agrawal, Singh, & Ghatak, 1994;Pastors, Blaisdell, Balm, Asplin, & Pohl, 1991;Ziai et al., 2005). Ziai et al. (2005) examined the effect of fiber supplementation as an adjunct to diet and metformin therapy in 49 patients with type II diabetes in a randomized, placebo-controlled trial. ...
Purpose: This review focuses on the health benefits of viscous versus nonvis-cous soluble fibers, why symptoms can occur with increased fiber consumption , and how to avoid symptoms to improve adherence with a high-fiber diet.
... Viscous soluble fibers have been shown to attenuate postprandial glucose and insulin responses, as well as reduce hunger feelings, in healthy subjects (Rigaud, Paycha, Meulemans, Merrouche, & Mignon, 1998;Sierra et al., 2001). In clinical studies of patients with type 2 diabetes, supplementing the diet with psyllium improves glycemic control in patients who are already on a highly restrictive diet (e.g., American Heart Association [AHA] Step 2) and taking oral hypoglycemic agents (Fagerberg, 1982;Gibb, Ramsey, Tse, & McRorie, 2011;Gupta, Agrawal, Singh, & Ghatak, 1994;Pastors, Blaisdell, Balm, Asplin, & Pohl, 1991;Ziai et al., 2005). Ziai et al. (2005) examined the effect of fiber supplementation as an adjunct to diet and metformin therapy in 49 patients with type II diabetes in a randomized, placebo-controlled trial. ...
This review focuses on the health benefits of viscous versus nonviscous soluble fibers, why symptoms can occur with increased fiber consumption, and how to avoid symptoms to improve adherence with a high-fiber diet.
Review of scientific literature as well as evidence-based guidelines and resources.
While it is generally known that "fiber is good for you," it is less well known that specific health benefits are associated with specific fiber characteristics. Many of the health benefits of fiber can be directly correlated with the viscosity of soluble fibers when hydrated (i.e., gel-forming). A reduction in viscosity of a given fiber will attenuate these health benefits, and a nonviscous fiber does not exhibit these health benefits.
Increasing the viscosity of chyme with a viscous soluble fiber has been shown clinically to lower cholesterol for cardiovascular health, improve glycemic control in type 2 diabetes, normalize stool form in both constipation (softens hard stool) and diarrhea (firms loose/liquid stool), and improve the objective clinical measures of metabolic syndrome (glycemic control, lipoprotein profile, body mass index/weight loss, and blood pressure).
... Seventy published reports were identified for a quantitative analysis. Three of these studies were included only in the dose-response analysis because they did not use a true lowfiber control but rather compared a high with a lower dose of the same intervention fiber (36)(37)(38). The 67 trials included in the analysis are summarized in Table 1 and included 25 trials of oat products (30)(31)(32)(33), 17 of psyllium (13,(60)(61)(62)(63)(64)(65)(66)(67)(68)(69)(70)(71)(72)(73)(74), 7 of pectin (13,(75)(76)(77)(78)(79)(80), and 18 of guar gum (81)(82)(83)(84)(85)(86)(87)(88)(89)(90)(91)(92)(93)(94)(95)(96)(97)(98). ...
The effects of dietary soluble fibers on blood cholesterol are uncertain.
This meta-analysis of 67 controlled trials was performed to quantify the cholesterol-lowering effect of major dietary fibers.
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.
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.
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.
... It appears that this fact can show the best effect of psyllium. Earlier studies reported that psyllium reduced fasting serum glucose concentrations in individuals with type 2 diabetes (Fagerberg, 1982) and in type 2 diabetic patients with chronic portalsystemic encephalopathy (Uribe et al, 1985). Other studies demonstrated that different preparations of ispaghula husk lowered postprandial serum glucose concentrations in type 1 (Florholmen et al, 1982), in type 2 diabetic patients (Sartor et al, 1981;Pastors et al, 1991;Anderson et al, 1999), in healthy volunteers (Sierra et al, 2001) and in both healthy and type 2 diabetic subjects (Jarjis et al, 1984). ...
The aim of this study was to evaluate the effects of psyllium in type 2 diabetic patients.
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, GHbA(1c), C-peptide and 24 h urinary glucose excretion. In addition, uric acid, cholesterol and several mineral and vitamin concentrations were also evaluated.
The study was performed at the Department of Pharmacology, Toxicology and Nursing at the University of León (Spain).
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/m(2) and that of women 25.9 kg/m(2).
Glucose absorption decreased significantly in the presence of psyllium (12.2%); this reduction is not associated with an important change in insulin levels (5%). GHbA(1c), 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.
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.
... Psyllium has been reported as a medicinally active natural polysaccharide. It has been used for the treatment of constipation (Bouchoucha et al., 2004; Ramkumar and Rao, 2005), diarrhea (Washington et al., 1998), inflammation bowel diseases-ulcerative colitis (Fernandez-Banares et al., 1999 ), obesity in children and adolescents (Pittler and Ernst, 2004), high cholesterol (Rodriguez-Moran et al., 1998; Moreyra et al., 2005; Romero et al., 2002; Anderson et al., 1995 Anderson et al., , 1999 Anderson et al., , 2000a,b) and diabetes (Anderson et al., 1999; Florholmen et al., 1982; Fagerberg, 1982; Gupta et al., 1994; Fukagawa et al., 1990; Pastors et al., 1991). Keeping in view, the pharmacological importance of psyllium polysaccharides, this article review the therapeutic importance of psyllium for the treatment of constipation , diarrhea, irritable bowel syndrome, inflammatory bowel disease-ulcerative colitis, colon cancer, diabetes and hypercholesterolemia . ...
There is no doubt that fibers, in particular viscous dietary fibers, have positive effects on human health, both in the prevention and in treatment of chronic diseases. Dietary fibers from psyllium have been used extensively both as pharmacological supplements, food ingredients, in processed food to aid weight control, to regulation of glucose control for diabetic patients and reducing serum lipid levels in hyperlipidemics. Keeping in view, the pharmacological importance of psyllium polysaccharide and its gel-forming nature, this article discusses the therapeutic value of psyllium for the treatment of constipation, diarrhea, irritable bowel syndrome, inflammatory bowel disease-ulcerative colitis, colon cancer, diabetes and hypercholesterolemia and exploitation of psyllium for developing drug delivery systems.
Fibers are proven to provide health benefits in preventing metabolic diseases. This chapter first presents the existing blood glucose monitoring sensors and a prediction model for blood glucose concentration. It also aims at analyzing the efficacy of a functional fiber, psyllium on the glycemic control function. Three studies included suggesting psyllium supplementation would significantly improve glycemic response while two studies included showed no effects. Advantages and limitations of each study were evaluated. Overall, it is generally believed that psyllium might give glycemic response improvement effect, especially in Type II Diabetes Mellitus patients.
Dietary fiber intake benefits individuals with a wide variety of metabolic conditions or gastrointestinal disorders. In the past decade the advantages of generous fiber intakes have been reported for persons with diabetes (Anderson, 1979; Anderson and Chen, 1979; Anderson and Ward, 1979; Jenkins et al, 1982), hypercholesterolemia (Anderson et al, 1984), hypertriglyceridemia (Anderson, 1980), obesity (Anderson et al., 1980a), or hypertension (Anderson, 1983). Individuals with high levels of dietary fiber intake are less likely to develop coronary heart disease (Morriset al1977; Kromhout et al., 1982; Liu et al., 1982) or colon cancer (Bingham et al., 1979) than their neighbors with low-fiber intakes. The role of dietary fiber in the prevention (Trowell, 1975) and management of diabetes (Anderson, 1979, Anderson and Chen, 1979; Anderson and Ward, 1979) has been studied extensively. This review will examine the effects of dietary fiber intake on glucose and lipid metabolism of lean diabetic individuals.
Research study was conducted to examine the effects of psyllium on different types of lipids in primary hyperlipidemic patients. It was conducted in JPMC Karachi, Pakistan, from December 2008 to June 2009. Forty hyperlipidemic patients were included, in research. Out of these 40, twenty patients were on placebo as control/compare group, and twenty were on psyllium, 10 grams daily for the period of three months. Exclusion criteria was patients with hypothyroidism, alcoholism, renal and hepatic disease. Serum cholesterol and triglycerides were estimated by the enzymatic calorimetric method. Serum HDL-Cholesterol was determined by direct method, at day zero and at last day of the treatment. LDL-Cholesterol was calculated by Friedwald formula (LDL= Tc- (TG/5 + HDL-C). Data were expressed as the mean ± SD and "t" test was applied to determine statistical significance of results. P value lesser than 0.05 was the limit of significance. When results compiled it was observed that two patients discontinued to take drug given, due to metallic test of psyllium husk. Psyllium decreased serum total cholesterol from 228.27±4.89 mg/dl to 199.22 ± 2.30 mg/dl, triglycerides from 169.27± 9.92 mg/dl to 164.5±8.56 mg/dl, LDL-Cholesterol from 159.72 ± 5.70 to 129.55± 2.81 mg/dl, and increased serum HDL-Cholesterol from 34.61±1.85 to 36.77±1.96 mg/dl in three months of treatment. Results of all parameters were significant when paired 't' test was applied for result analysis. At end of the research work we concluded that psyllium is very effective agent to maintain lipid profile parameters at normal limits in hyperlipidemic patients.
Psyllium is a bulk-forming laxative and is high in both fiber and mucilage. The beneficial effect of dietary- fiber in the management of type II diabetes has not been totally demonstrated. The purpose of this to determine the plasma- lowering of 5 g b.i.d. of psyllium husk fiber, as an adjunct to dietary therapy, on lipid and glucose levels, in Iranian-patients with type II diabetes. Patients were randomly selected from an outpatient clinic of primary care to participate in a double-blind placebo-controlled study in which Plantago Psyllium or placebo was given in combination with a low fat diet. Forty-nine subjects were included in the study that were diet counseling before and then followed an 8-week treatment period. Fasting-plasma glucose was measured every 2 weeks, and total plasma cholesterol, LDL cholesterol, BDPL cholesterol, triglyceride, and insulin levels were measured every 4 weeks. Glycosylatd hemoglobin was also measured at the beginning and end of the treatment period. The test, products (psyllium or placebo) were supplied to subjects in identically labed foil packets containing a 5-g dose of product, to consume two doses per day (of 5 g each one), half an hour before breakfast and dinner. Both products were well tolerated, with no serious adverse events related to treatment reported in either. Some of the psyllium patients reported that their gastric tolerance to metformin became better. Fasting plasma glucose, and Glycosylated hemoglobim, showed a significant reduction (p < 0.05), whereas HDL cholesterol increased significantly (p < 0.05) following Psyllium treatment. Our results show that 5 g b.i.d. of Psyllium for persons with diabetes is safe, is well tolerated, and improves glycemic and lipid control in patients with type 2 diabetes and hypercholesterolemia.
Objective
This double-blind, placebo-controlled clinical study was designed to evaluate the effects of psyllium on fasting blood glucose (FBG) and HbA1c in patients being treated for type-2 diabetes mellitus (T2DM).Research design and methodsPatients were randomly assigned to 1 of the 3 treatment groups: placebo, psyllium 3.4 g BID or psyllium 6.8 g BID (just prior to breakfast and dinner). Patients had a total of 9 clinic visits during the 20-week study period (8 weeks baseline, 12 weeks treatment). A total of 37 patients [12 females, 34 Caucasians, mean age 62 years] were enrolled (8 in the placebo group, 15 in the psyllium 3.4 g BID group and 14 in the psyllium 6.8 g BID group) and were included in the Intent-to-Treat analysis.ResultsBoth doses of psyllium significantly (p<0.05) lowered FBG compared to placebo at treatment weeks 4, 8, and 12. Psyllium 6.8 g BID significantly lowered HbA1c compared to placebo at Week 8 (−0.58±0.18, p=0.003), and both the 3.4 g dose and the 6.8 g dose of psyllium significantly (p<0.05) lowered HbA1c compared to placebo at Week 12 (−0.53±0.20, p=0.013; −0.65±0.20, p=0.003, respectively).Conclusions
The improvement in glycemic control observed with psyllium in T2DM patients was above that already conferred by a restricted diet (all patients) and a stable dose of a sulfonylurea (81.1% of patients). These data support that psyllium is an effective co-therapy for improving glycemic control in patients being treated for T2DM. NCT01582282.
To see if a modest amount of soluble fiber reduced blood lipids in subjects with hyperlipidemia who were on a low-fat diet, 42 subjects (21 men, 21 women) consuming an American Heart Association step 2 diet took two servings of breakfast cereal daily for two 2-week periods in a randomized crossover trial. There were two types of test cereals, each providing 6.7 g psyllium fiber daily, and two types of wheat bran control cereals, matched for available carbohydrate and total fiber. Half the subjects tested each type of cereal, and the results were pooled because the psyllium cereals had similar effects on serum cholesterol levels. Comparing values at the end of 2 weeks, psyllium reduced serum total (6.33 +/- 0.12 mmol/L versus 6.76 +/- 0.12 mmol/L, p < 0.001), low-density lipoprotein (LDL; 4.36 +/-0.11 mmol/L versus 4.73 +/- 0.12 mmol/L, p < 0.001) and high-density lipoprotein cholesterol levels (HDL; 1.10 +/- 0.05 mmol/L versus 1.14 +/- 0.05 mmol/L, p < 0.05) and the LDL/HDL cholesterol ratio (4.27 +/- 0.20 versus 4.48 +/- 0.22, p < 0.02) with no effect on triglycerides. There was no significant interaction between the effects of treatment and sex for any of the blood lipid variables. Women tended to have greater decreases in total, LDL, and HDL cholesterol levels than men, but the percent decrease in LDL/HDL ratio on psyllium was similar in men, 4.9%, and women, 4.7%. It is concluded that 6.7 g of psyllium fiber daily, with a low-fat diet, reduces serum cholesterol levels in both men and women with hyperlipidemia.
(C) Copyright 1994 Southern Society for Clinical Investigation
IntroductionCholesterol-lowering effectsReferences
There is no doubt that fibers, in particular viscous dietary fibers, have positive effects on human health, both in the prevention and in treatment of chronic diseases. Psyllium, a medicinally important serum glucose reducing natural polysaccharide, if suitably tailored to prepare the hydrogels for controlled release of insulin; it can act as double potential candidate for cure of diabetes mellitus. Keeping in view the therapeutic importance of psyllium and its gel-forming nature we have prepared psyllium and methacrylamide based hydrogels by using N,N′-methylenebisacrylamide as crosslinker. The present paper discusses the effect of pH on swelling kinetics of the hydrogels and release dynamics of insulin from drug-loaded hydrogels, for the evaluation of the swelling mechanism and drug release mechanism from the hydrogels. Non-Fickian diffusion mechanism has been observed for the release of insulin in pH 2.2 buffer and pH 7.4 buffer.
The goal of the current study was to determine the mechanism of the hypocholesterolemic effect of psyllium using a randomized, double-blind, crossover design. Twenty males (age 44 +/- 4 yr, weight 79 +/- 10 kg) with moderate hypercholesterolemia (total 265 +/- 17 mg/dl, low density lipoprotein (LDL) 184 +/- 15 mg/dl) were studied at baseline (B) and after randomization to receive a 40-day course of 15 g/day of either psyllium (Ps) or placebo (Pl) (cellulose). After a washout period (11 +/- 2 days), subjects were crossed over to the other fiber treatment for an additional 40 days and restudied. Intestinal cholesterol absorption, cholesterol synthesis in isolated peripheral blood mononuclear cells, bile acid kinetics, gallbladder motility, and intestinal transit were measured at each study period. Psyllium lowered LDL cholesterol (x:184 (B), 169 (Ps), and 179 (Pl) mg/dl; Ps vs. B,Pl: P less than 0.004, P less than 0.02), decreased relative cholesterol absorption (x:51 (B), 45 (Ps), and 49 (Pl) %; Ps vs. B,Pl: P less than 0.03, P less than 0.03), did not alter absolute cholesterol absorption, and increased the fractional turnover of both chenodeoxycholic acid (x:0.176 (B), 0.203 (Ps), and 0.170 (Pl) day-1; Ps vs. B,Pl: P less than 0.0001, P less than 0.01) and cholic acid (x:0.303 (B), 0.411 (Ps), and 0.301 (Pl) d-1; Ps vs. B, Pl: P less than 0.006, P less than 0.002). Bile acid synthesis increased in subjects whose LDL cholesterol was lowered by more than 10% (Ps vs. B: 1304 +/- 489 vs 992 +/- 307 mumol/day, P less than 0.006; Ps vs. PI: 1304 +/- 489 vs. 914 +/- 321 mumol/day, P less than 0.0002). We conclude that psyllium lowers LDL cholesterol primarily via stimulation of bile acid synthesis.
The hypocholesterolemic effects of oat bran (OB) have been recently challenged. To carefully document the hypocholesterolemic effects of OB, 20 hypercholesterolemic men admitted to a metabolic ward were randomly allocated to either OB or wheat bran (WB) for 21 d after a 7-d control-diet period. Control and treatment diets were designed to be identical in energy content and nutrients, differing only in the amount of soluble fiber. After 21 d, OB significantly decreased total cholesterol by 12.8% (P less than 0.001), low-density-lipoprotein cholesterol by 12.1% (P less than 0.004), and apolipoprotein B-100 by 13.7% (P less than 0.001) whereas WB had no significant effect. High-density-lipoprotein cholesterol and apolipoprotein A-I did not change significantly in either group. Serum triglycerides decreased by 10% in both groups but the decrease was only significant (P less than 0.04) in WB subjects. OB but not WB significantly reduced total cholesterol and other atherogenic lipoprotein fractions independent of other dietary changes.
The ability of psyllium fiber to reduce postprandial serum glucose and insulin concentrations was studied in 18 non-insulin-dependent diabetic patients in a crossover design. Psyllium fiber or placebo was administered twice during each 15-h crossover phase, immediately before breakfast and dinner. No psyllium fiber or placebo was given at lunch, which allowed measurement of residual or second-meal effects. For meals eaten immediately after psyllium ingestion, maximum postprandial glucose elevation was reduced by 14% at breakfast and 20% at dinner relative to placebo. Postprandial serum insulin concentrations measured after breakfast were reduced by 12% relative to placebo. Second-meal effects after lunch showed a 31% reduction in postprandial glucose elevation relative to placebo. No significant differences in effects were noted between patients whose diabetes was controlled by diet alone and those whose diabetes was controlled by oral hypoglycemic drugs. Results indicate that psyllium as a meal supplement reduces proximate and second-meal postprandial glucose and insulin concentrations in non-insulin-dependent diabetics.
This study was designed to test the hypocholesterolemic effect of soy cotyledon fiber in the diet as ready-to-eat cereal and white bread, in free-living subjects having mildly elevated, fasting plasma total cholesterol levels. Twenty subjects completed a 15-week double-blind crossover design protocol. It consisted of two 6-week test periods and a 3-week rest period in between the two test periods. Subjects were randomly allotted to two test groups with comparable initial cholesterol levels. Fifteen grams of dietary fiber per day from soy cotyledon fiber was supplemented in three divided doses (equivalent to 20 g Fibrim soy fiber/day). Dietary records were kept for 3 consecutive days for each test period and were calculated using a computer program. Subjects were asked to maintain their normal eating habits and body weights throughout the 15-week protocol. There were no significant differences in nutrient intake between the two supplementation periods based on 3 day dietary records, except that the amount of fiber intake was significantly higher when soy cotyledon fiber was supplemented (24 g vs. 13 g/day). Soy cotyledon fiber supplementation did not produce visible intolerance. Body weights and blood pressures were not significantly affected. Soy cotyledon fiber supplementation significantly lowered plasma total cholesterol by 7.7% (from 240 to 222 mg/dl, P less than 0.01) and LDL-cholesterol by 7.4% (from 159 to 145 mg/dl, P less than 0.04). Plasma HDL-cholesterol and total triglycerides were not significantly affected.(ABSTRACT TRUNCATED AT 250 WORDS)
Soluble dietary fiber, including psyllium, has been shown to have mild to modest cholesterol lowering properties. Psyllium hydrophilic mucilloid (Metamucil, Procter and Gamble, Cincinnati, OH), a bulk laxative, when used as a dietary supplement in combination with a low fat diet, can lower total serum cholesterol and low-density lipoprotein (LDL) cholesterol, and raise high-density lipoprotein (HDL) cholesterol in hypercholesterolemic patients. The cholesterol lowering effects of psyllium are much less evident than those observed with cholestyramine and the HMG-CoA reductase inhibitors. The mechanism for the cholesterol lowering effect of psyllium is not known. The substance is well tolerated with long-term use.
Soluble-fiber breakfast cereals were examined for their cholesterol-lowering ability in 58 male patients with mild to moderate hypercholesterolemia in a randomized, double-blind, placebo-controlled study. Patients followed a step 1 diet for a minimum of 6 wk, then were randomly assigned to groups incorporating either corn flakes or one of two soluble-fiber cereals (pectin enriched or psyllium enriched) in the diet for an additional 6 wk. During the diet-only phase, total cholesterol dropped 3.8%. During the cereal-plus-diet phase, total and LDL cholesterol values of the pectin-enriched cereal group dropped an additional 2.1% (P = 0.243) and 3.9% (P = 0.16), respectively, and they dropped 5.9% (P = 0.005) and 5.7% (P = 0.034), respectively, in the psyllium-enriched cereal group. During the cereal-plus-diet phase, no significant effects on HDL cholesterol, triglyceride, or body weight were found within or between any cereal groups. These results support use of soluble-fiber cereals as an effective and well-tolerated part of a prudent diet in the treatment of mild to moderate hypercholesterolemia.
We investigated psyllium fiber supplementation as a means of enhancing the cholesterol-lowering effect of the phase I American Heart Association diet. Fifty-nine subjects with total serum cholesterol (TC) levels ranging from 5.56 to 10.24 mmol/L (215 to 396 mg/dL) were given a 2-month dietary lead-in followed by 3 months of diet only (29 subjects) or diet supplemented with 20.4 g of psyllium daily (30 subjects). Unlike women, men had a significant decrease in levels of both TC (-8.0%) and low-density lipoprotein cholesterol (LDL-C) (-10.1%) during the dietary lead-in. Psyllium supplementation resulted in an additional 5.5% reduction in the TC levels as compared to diet alone. Psyllium supplementation combined with dietary lead-in resulted in an overall 17.3% decrease in the TC and a 20.0% decrease in LDL-C for men, with decreases of 7.7% and 11.6%, respectively, for women. Psyllium effectively enhances the cholesterol-lowering effect of the phase I diet.
Seventy-five patients affected by chronic constipation were treated for 4 weeks with an Ispaghula Husk preparation (Fibrolax®), a bulk-forming laxative.
Frequency, stool consistency, abdominal pain and signs of venous stasis improved after treatment. No important side-effect was recorded. Cholesterol, HDL-cholesterol and triglycerides did not show significant changes.
To determine the cholesterol-lowering effect of ready-to-eat cereal containing soluble fibre as psyllium (86%), oatmeal and barley on the plasma lipids of otherwise healthy men with mild hypercholesterolaemia, who were already eating a diet low in saturated fats.
Double-blind crossover trial, lasting 12 weeks, in volunteers eating each cereal for six weeks at home, in Sydney and Newcastle (New South Wales).
Eighty-one men (average age 50 years; range, 31-69 years) who had initial plasma (total) cholesterol concentrations of 5.8-8.8 mmol/L, but did not have major illness, obesity or diabetes, and were not on special diets or taking stool bulkers.
One box of cereal was eaten each day: control, 60 g wheat/wheat bran (2 g soluble fibre); or test, 50 g of product containing psyllium/oats/barley (12 g soluble fibre). Subjects were allocated at random, when established on a low saturated fat diet, to wheat followed by psyllium cereal or psyllium followed by wheat cereal.
Plasma total cholesterol, high density lipoprotein cholesterol, triglyceride and low density lipoprotein cholesterol concentrations measured twice, four to seven days apart before the start of the trial and then after six weeks of eating each cereal.
Compliance was excellent with both cereals. There were no significant differences in subjects' macronutrient intake or body weight between the two six-week periods. Total cholesterol and low density lipoprotein cholesterol concentrations fell significantly on psyllium cereal, relative to wheat cereal, in both periods at both centres (mean -3.2% and -4.4%, respectively). There were no consistent changes in triglyceride or high density lipoprotein cholesterol concentrations.
This type of product, which is easy to consume on a daily basis, is a useful adjunct to the dietary management of mild hypercholesterolaemia.
Although fiber has been increasingly recognized as an important dietary constituent, controversy and confusion still exist about the physiologic effects of fiber. Specifically, the independent ability of dietary fiber to lower serum lipid levels is controversial. The purpose of this article is to review available evidence regarding the impact of soluble fibers on serum lipid levels. Soluble fibers appear to have a greater potential to alter serum lipid levels than do insoluble fibers. Significant reduction in the level of serum total cholesterol by soluble fiber was found in 68 of the 77 (88%) human studies reviewed. Of the studies measuring low-density lipoprotein cholesterol, 41 of 49 (84%) reported significant reductions. No significant changes were reported in 43 of the 57 (75%) studies that reported high-density lipoprotein cholesterol and/or in 50 of the 58 (86%) studies that measured triglyceride levels.
To determine whether psyllium must be mixed with food to lower serum cholesterol, 18 modestly hypercholesterolemic subjects were studied for three 2-wk periods, in random order, separated by a 2-wk return to a National Cholesterol Education Program Step 2 diet. Compared with values for subjects consuming control wheat-bran cereal (63 g/d), after 2 wk of 54 g psyllium-enriched cereal/d containing 7.3 g psyllium, serum total, LDL, and HDL cholesterol, respectively, were reduced by 8% (6.15 +/- 0.15 vs 6.71 +/- 0.19 mmol/L, P < 0.01), 11% (4.24 +/- 0.15 vs 4.78 +/- 0.19 mmol/L, P < 0.02), and 7% (0.99 +/- 0.05 vs 1.07 +/- 0.05 mmol/L, P < 0.01). When 7.6 g of the same type of psyllium as in the test cereal was taken between meals, serum total (6.50 +/- 0.19 mmol/L), LDL (4.50 +/- 0.21 mmol/L), and HDL (1.06 +/- 0.06 mmol/L) cholesterol were no different from control values, and total cholesterol was greater than after psyllium cereal (P < 0.05). We conclude that psyllium must be mixed with foods to have the maximum effect on serum cholesterol.
In recent years, there has been a growing interest in the use of dietary fiber in health maintenance and disease prevention. A deficiency of fiber in the Western diet may be contributing to the current epidemics of diabetes mellitus, coronary artery disease (CAD), and colonic cancer. The awareness of fiber as a dietary supplement may have contributed to the reported 30% decline in death rate from CAD observed over the past 15 years. Psyllium is a soluble gel-forming fiber that has been shown to bind to the bile acids in the gut and prevent their normal reabsorption, similar to the bile acid sequestrant drugs. Psyllium is useful as an adjunct to dietary therapy (step 1 or step 2 American Heart Association [AHA] diet) in the treatment of patients with mild-to-moderate hypercholesterolemia. In combination with other cholesterol-lowering drugs, such as statins, psyllium provides an added benefit on cholesterol lowering, and is well tolerated and cost-effective.
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