Effects of the Soluble Fiber Complex PolyGlycopleX® on Glucose Homeostasis and Body Weight in Young Zucker Diabetic Rats

Dietary fiber can reduce insulin resistance, body weight, and hyperlipidemia depending on fiber type, water solubility, and viscosity. PolyGlycopleX® (PGX®) is a natural, novel water soluble, non-starch polysaccharide complex that with water forms a highly viscous gel compared to other naturally occurring dietary fiber. We determined the effect of dietary PGX® vs. cellulose and inulin on the early development of insulin resistance, body weight, hyperlipidemia, and glycemia-induced tissue damage in young Zucker diabetic rats (ZDFs) in fasted and non-fasted states. ZDFs (5 weeks old) were fed a diet containing 5% (wgt/wgt) cellulose, inulin, or PGX® for 8 weeks. Body weight, lipids, insulin, and glucose levels were determined throughout the study and homeostasis model assessment (HOMA) was used to measure insulin sensitivity throughout the study in fasted animals. At study termination, insulin sensitivity (oral glucose tolerance test, OGTT) and kidney, liver, and pancreatic histopathology were determined. Body weight and food intake were significantly reduced by PGX® vs. inulin and cellulose. Serum insulin in fasted and non-fasted states was significantly reduced by PGX® as was non-fasted blood glucose. Insulin resistance, measured as a HOMA score, was significantly reduced by PGX® in weeks 5 through 8 as well as terminal OGTT scores in fed and fasted states. Serum total cholesterol was also significantly reduced by PGX®. PGX® significantly reduced histological kidney and hepatic damage in addition to reduced hepatic steatosis and cholestasis. A greater mass of pancreatic β-cells was found in the PGX® group. PGX® therefore may be a useful dietary additive in the control of the development of the early development of the metabolic syndrome

Consumption of the Soluble Dietary Fibre Complex PolyGlycopleX(®) Reduces Glycaemia and Increases Satiety of a Standard Meal Postprandially

The effect of consumption of PolyGlycopleX(®) (PGX(®)) was compared to wheat dextrin (WD) in combination with a standard meal, on postprandial satiety and glycaemia in a double-blind, randomised crossover trial, of 14 healthy subjects trained as a satiety panel. At each of six two-hour satiety sessions, subjects consumed one of three different test meals on two separate occasions. The test meals were: a standard meal plus 5 g PGX; a standard meal plus 4.5 g of PGX as softgels; and a standard meal plus 5 g of WD. Subjects recorded fullness using a labelled magnitude scale at 0, 15, 30, 45, 60, 90, and 120 min and the total area under the curve (AUC), mean fullness vs. time was calculated. The meals with PGX (in granular and softgel form) gave higher satiety (AUC) (477 ± 121 and 454 ± 242 cm·min), than the meal with WD (215 ± 261 cm·min) (p < 0.001). Subjects had blood glucose levels measured after the meals with PGX (granules) and WD. Glucose response (AUC) was significantly lower (p < 0.001) after the PGX meal than for the WD meal.  The high viscosity reported for PGX is a likely mechanism behind the significant satiety and blood glucose modulating effects observed in this study

Effect of Fibre Supplementation on Body Weight and Composition, Frequency of Eating and Dietary Choice in Overweight Individuals

Fibre supplementation can potentially reduce energy intake and contribute to weight loss. The mechanism may be reduced frequency of eating, resulting in reduced food consumption. The objective of this research was to determine the effectiveness of fibre supplementation with PolyGlycopleX® (PGX®), on body weight and composition, frequency of eating and dietary intake in 118 overweight adults. In a three-arm, parallel, blind, randomised controlled trial participants were randomised to one of three groups; 4.5 g PGX as softgels (PGXS), 5 g PGX granules (PGXG) or 5 g rice flour (RF) control. Prior to supplementation and at 12 weeks, participants captured before and after images of all food and beverages consumed within 4 days using a mobile food record app (mFR). The mFR images were analysed for food group serving sizes and number of eating occasions. In the PGXG group, intention-to-treat analysis showed there was a significant reduction in waist circumference (2.5 cm; p = 0.003). Subgroup analysis showed that PGXG supplementation at the recommended dose resulted in a reduction in body weight (-1.4 ± 0.10 kg, p < 0.01), body mass index (BMI) reduction (-0.5 ± 0.10, p < 0.01), reduced number of eating occasions (-1.4 ± 1.2, p < 0.01) and a reduced intake of grain food (-1.52 ± 1.84 serves, p = 0.019). PGXG at the recommended dose resulted in a reduction in weight and BMI which was significantly greater than that for RF (p = 0.001). These results demonstrate the potential benefits of PGX fibre in controlling frequency of eating and in weight loss

Effect of Training on the Reliability of Satiety Evaluation and Use of Trained Panellists to Determine the Satiety Effect of Dietary Fibre: A Randomised Controlled Trial

Background: The assessment of satiety effects on foods is commonly performed by untrained volunteers marking their perceived hunger or fullness on line scales, marked with pre-set descriptors. The lack of reproducibility of satiety measurement using this approach however results in the tool being unable to distinguish between foods that have small, but possibly important, differences in their satiety effects. An alternate approach is used in sensory evaluation; panellists can be trained in the correct use of the assessment line-scale and brought to consensus on the meanings of descriptors used for food quality attributes to improve the panel reliability. The effect of training on the reliability of a satiety panel has not previously been reported. Method: In a randomised controlled parallel intervention, the effect of training in the correct use of a satiety labelled magnitude scale (LMS) was assessed versus no-training. The test-retest precision and reliability of two hour postprandial satiety evaluation after consumption of a standard breakfast was compared. The trained panel then compared the satiety effect of two breakfast meals containing either a viscous or a non-viscous dietary fibre in a crossover trial.Results: A subgroup of the 23 panellists (n = 5) improved their test re-test precision after training. Panel satiety area under the curve, “after the training” intervention was significantly different to “before training” (p < 0.001). Reliability of the panel determined by intraclass correlation (ICC) of test and retest showed improved strength of the correlation from 0.70 pre-intervention to 0.95 post intervention. The trained “satiety expert panel” determined that a standard breakfast with 5g of viscous fibre gave significantly higher satiety than with 5g non-viscous fibre (area under curve (AUC) of 478.2, 334.4 respectively) (p ≤ 0.002). Conclusion: Training reduced between panellist variability. The improved strength of test-retest ICC as a result of the training intervention suggests that training satiety panellists can improve the discriminating power of satiety evaluation

Effect on Insulin, Glucose and Lipids in Overweight/Obese Australian Adults of 12 Months Consumption of Two Different Fibre Supplements in a Randomised Trial

Higher fibre intakes are associated with risk reduction for chronic diseases. This study investigated the effects of supplementation with PolyGlycopleX® (PGX), a complexed polysaccharide, on insulin, glucose and lipids in overweight and obese individuals. In this double-blind 12 months study, participants were randomised into three groups: control (rice flour); PGX or psyllium (PSY). Participants followed their usual lifestyle and diet but consumed 5 g of their supplement before meals. Insulin was significantly lower in the PGX and PSY groups compared to control at 3 and 6 months and in the PSY group compared to control at 12 months. Serum glucose was significantly lower in the PGX group at 3 months compared to control. Total cholesterol was significantly lower in the PGX and PSY groups compared to control at 3 and 6 months. High density lipoprotein (HDL) cholesterol was significantly increased in the PGX group compared to control at 12 months. low density lipoprotein (LDL) cholesterol was significantly lower in the PGX group at 3 and 6 months compared to control and in the PSY group at 3 months compared to control. A simple strategy of fibre supplementation may offer an effective solution to glucose, insulin and lipid management without the need for other nutrient modification.Land and Food Systems, Faculty ofNon UBCReviewedFacult

Effect on body weight and composition in overweight/obese Australian adults over 12 months consumption of two different types of fibre supplementation in a randomized trial

Background/Objectives: Higher fibre intakes are associated with risk reduction for chronic diseases. However, many people find difficulty in consuming sufficient fibre through their diet. Supplements may be an effective alternative. We aimed to investigate the effects of PolyGlycopleX® (PGX®), a proprietary polysaccharide complex and a proprietary Psyllium product (PgxSyl™) (PSY) on diet, body weight and composition in overweight and obese individuals. Subjects/Methods: This was a double-blind 52 weeks study with 159 people randomized to 3 groups: control (rice flour); PGX (PGX) and proprietary psyllium (PSY). Participants did not change any of their usual habits or diet except they consumed 5 g of supplement taken with a total of 500 ml of water 5–10 min before meals. Results: Weight was significantly lower in the PGX group compared to control at 3 (−1.6 kg [0.57, 2.67, p = 0.003]), 6 (−2.6 kg [1.01, 4.13, p = 0.001]) and 12 months (−2.6 kg [0.59, 4.64, p = 0.012]) and in the PSY group compared to control group at 3 (−1.1 kg [0.07, 2.12, p = 0.037]) and 6 months (−2.4 kg [0.95, 3.93, p = 0.002]). This was a difference of − 2.8% for the PGX group and − 1.5% for the PSY group compared to control after 12 months supplementation. Body Fat was significantly lower in PGX compared to control at 6 (−1.8 kg [0.63, 2.95, p = 0.003]) and 12 months (−1.9 kg [0.43, 3.36, p = 0.012]) and in PSY compared to control at 6 (−1.9 kg [0.84, 3.04, p = 0.001]) and 12 months (−1.4 kg [0.08, 2.71, p = 0.038]). Conclusions: PGX was better than PSY at maintaining dietary changes and weight loss over the 12 month intervention period, with no change to exercise. A simple strategy of PGX supplementation may offer an effective solution to long-term weight-loss and then management without the need for other nutrient modification. Trial registration: ANZCTR: ACTRN12611000415909 . Registered 20 April 2011Other UBCNon UBCReviewedFacult

Micronutrient status of individuals with overweight and obesity following 3 months’ supplementation with PolyGlycopleX (PGX®) or psyllium: a randomized controlled trial

Background Safe and effective weight control strategies are needed to curtail the current obesity epidemic worldwide. Increasing dietary fibre has shown positive results with weight loss as well as in the reduction of metabolic syndrome risk factors. However, fibre can act as an inhibitor to the bioavailability of micronutrients in the gastrointestinal tract. While there is a substantial amount of scientific research into psyllium fibre, PolyGlycopleX (PGX®) is a novel fibre and as yet the effects of PGX® on micronutrient status is not well researched. Aim To determine whether 3-months’ supplementation with 15 g of psyllium or PGX® fibre daily affects micronutrient status of overweight and obese adults. Methods Overweight and obese individuals with a BMI between 25–40 kg/m2 and aged between 18 and 65 years, but otherwise healthy, were instructed to consume a 5 g sachet of psyllium, PGX® fibre or a rice flour placebo three times a day for 52 weeks as part of a larger long-term study. Blood sample data for the first 3 months were analysed for associations between serum micronutrient levels and psyllium fibre and/or PGX® supplements. Results No significant differences between fibre supplement groups and micronutrient status were found after 3 months at p > 0.05. Dietary intake of vitamin C was significantly lower for PGX® at 3 months compared to baseline and compared to control (p < 0.05). Folate was significantly lower in the control group after 3 months (p < 0.05). In the psyllium group, folate, sodium, zinc and magnesium intake decreased after 3 months (p < 0.05). A limitation of dietary intake data (tertiary measure) is the potential for inaccurate self-reporting, although reduced nutrient intake could be due to the satiating effect of dietary fibre. Conclusions There were no significant between group differences in serum micronutrient concentrations after a 3-month psyllium fibre or PGX® supplementation intervention of 15 g per day. Fibre supplementation is unlikely to compromise the nutritional status of overweight and obese individuals in the short term. Further research is recommended to monitor micronutrient status over a longer period or with a higher fibre dosage.Land and Food Systems, Faculty ofNon UBCReviewedFacultyResearche

Viscosity development during aqueous dispersion and dissolution: a comparison of PGX® with other dietary supplements and individual polysaccharides

Viscosity development with time was studied during the aqueous dissolution of the novel polysaccharide complex PGX®, a finer particle size version used in meal replacement PGXf, and a blend of the three polysaccharides 3PB used in their manufacture. Results were compared with those of single polysaccharides and other commercially available soluble-fibre supplements. Measurements were made at 25.0 C in a rheometer vane and cup system at ~1000 s-1. Samples suspended in low MW PEG were discharged from a syringe into water under shear in the measuring system. Final mixtures contained 0.5% w/w sample and 2% w/w PEG. Most samples reaching high final equilibrium/ultimate viscosities (12e138 mPa s), appeared to dissolve completely within 1 h but four samples required 1.5 to >14 h. PGX®, PGXf and 3PB gave the highest ultimate viscosities within timescales relevant to stomach emptying. Viscosityetime data were reasonably reproducible except those for xanthan gum. Distinct steps in viscosity development curves for 3PB and Biomed Type 2 were attributed to different dissolution rates of their component polysaccharides. For samples reaching final viscosities < 12 mPa s, dietary fibre products often left residues of insoluble material whilst single polysaccharides appeared to dissolve completely. Attempts at curve fitting the dissolution profiles to single-exponential or logarithmic models failed. Better representations were obtained using a two-component exponential model due to Kravtchenko, Renoir, Parker, and Brigand (1999) or a four-component extension of this model. Dissolution rates were also compared using time to reach 50 and 80% of the ultimate viscosity at full dissolution

Designing Vitamin D₃ Formulations: An In Vitro Investigation Using a Novel Micellar Delivery System

Vitamin D is an essential nutrient with important immunomodulatory properties. As a fat-soluble compound, Vitamin D (and its D3 form) is immiscible with water, which presents challenges to absorption. In an in vitro setting, the current study characterizes novel micellar formulations of Vitamin D3 designed to improve absorption. Techniques used to evaluate and compare the micellar formulations against a non-micellar formula include the following: cryo-SEM to determine morphology; laser diffraction to determine particle size and distribution; zeta potential to determine stability of the particles; solubility assays to determine solubility in water and gastrointestinal media; and Caco-2 cell monolayers to determine intestinal permeability. Results show advantageous features (particle size range in the low micrometres with an average zeta potential of −51.56 ± 2.76 mV), as well as significant improvements in intestinal permeability, in one optimized micellar formula (LipoMicel®). When introduced to Caco-2 cells, LipoMicel’s permeability was significantly better than the control (p 3 (LipoMicel) has the potential to promote absorption of Vitamin D3. Thus, it can serve as a promising candidate for follow-up in vivo studies in humans