A Comparison and Safety Evaluation of Micellar versus Standard Vitamin D3 Oral Supplementation in a Randomized, Double-Blind Human Pilot Study.

The aim of this pilot study was to evaluate and compare bioavailability and safety of two Vitamin D3 formulations (softgels) in healthy adults, at single daily doses of 1000 and 2500 IU, over a 60-day period. A total of 69 participants were initially screened for eligibility in a double-blind randomized study with a four-arm parallel design; 35 participants were randomized to treatment groups: (1) standard Vitamin D3 1000 IU (STD1000), (2) micellar Vitamin D3 1000 IU (LMD1000), (3) standard Vitamin D3 2500 IU (STD2500), and (4) micellar Vitamin D3 2500 IU (LMD2500). Serum Vitamin D concentrations were determined through calcifediol [25(OH)D] at baseline (=before treatment), at day 5, 10, and 15 (=during treatment), at day 30 (=end of treatment), and at day 45 and 60 (=during follow-up/post treatment). Safety markers and minerals were evaluated at baseline and at day 30 and day 60. The pharmacokinetic parameters with respect to iAUC were found to be significantly different between LMD1000 vs. STD1000: iAUC(5-60): 992 ± 260 vs. 177 ± 140 nmol day/L; p < 0.05, suggesting up to 6 times higher Vitamin D3 absorption of LMD when measured incrementally. During follow-up, participants in the LMD1000 treatment group showed approx. 7 times higher Vitamin D3 concentrations than the STD1000 group (iAUC(30-60): 680 ± 190 vs. 104 ± 91 nmol day/L; p < 0.05). However, no significant differences were found between the pharmacokinetics of the higher dosing groups STD2500 and LMD2500. No significant changes in serum 1,25(OH)2D concentrations or other biochemical safety markers were detected at day 60; no excess risks of hypercalcemia (i.e., total serum calcium > 2.63 mmol/L) or other adverse events were identified. LMD, a micellar delivery vehicle for microencapsulating Vitamin D3 (LipoMicel®), proved to be safe and only showed superior bioavailability when compared to standard Vitamin D at the lower dose of 1000 IU. This study has clinical trial registration: NCT05209425.

A Pharmacokinetic Study of Different Quercetin Formulations in Healthy Participants: A Diet-Controlled, Crossover, Single- and Multiple-Dose Pilot Study.

This study aimed to evaluate the blood concentrations of quercetin in healthy participants after the administration of different formulations in single- and multiple-dose phases. Ten healthy adults (males, 5; females, 5; age 37 ± 11 years) participated in a diet-controlled, crossover pilot study. Participants received three different doses (250 mg, 500 mg, or 1000 mg) of quercetin aglycone orally. In the single-dose study, blood concentrations (AUC0-24 and Cmax) of standard quercetin were compared with those of LipoMicel®-a food-grade delivery form of quercetin. In the multiple-dose study, blood concentrations of formulated quercetin were observed over 72 h, after repeated doses of LipoMicel (LM) treatments. The AUC0-24 ranged from 77.3 to 1128.9 ng·h/ml: LM significantly increased blood concentrations of quercetin by 7-fold (LM 500) compared to standard quercetin, when tested at the same dose, over 24 h (p < 0.001); LM administered at a higher dose (LM 1000) achieved 15-fold higher absorption (p < 0.001); LM tested at half a dose of standard quercetin increased concentration by approx. 3-fold (LM 250). Quercetin blood concentrations were attained over 72 h. The major metabolites measured in the blood were methylated, sulfate, and glutathione (GSH) conjugates of quercetin. Significant differences in concentrations between quercetin conjugates (sulfate vs. methyl vs. GSH) were observed (p < 0.001). Data obtained from this study suggest that supplementation with LipoMicel® is a promising strategy to increase the absorption of quercetin and its health-promoting effects in humans. However, due to the low sample size in this pilot study, further research is still warranted to confirm the observations in larger populations. This trial is registered with NCT05611827.

A randomized, double-blind, placebo-controlled, cross-over trial to evaluate the effect of EstroSense® on 2-hydroxyestrone:16α-hydroxyestrone ratio in premenopausal women.

OBJECTIVES: Some estrogen metabolites are associated with increased breast cancer risk, while others are protective. Research efforts have focused on modifiable factors, including bioactive compounds found in food or supplements, promoting estrogen profiles with anti-cancer properties. EstroSense® is a nutraceutical product with bioactive compounds, including Indole-3-carbinol and green-tea catechins, which may favourably affect estrogen profiles. This study was conducted to determine if EstroSense use, compared to placebo, promotes a higher urinary 2-hydroxyestrone:16α-hydroxyestrone ratio (2-OHE1:16α-OHE1), a biomarker associated with a lowered risk of breast cancer. METHODS: A total of 148 premenopausal women were recruited from British Columbia, Canada to participate in a randomized, double-blind, cross-over, multicentre, placebo-controlled study in which women were randomized to a treatment sequence that consisted of either EstroSense®, followed by placebo or vice-versa. The women were instructed to consume three capsules per day of EstroSense® or the placebo for three menstrual cycles (∼12 weeks). The primary outcome was the measurement of 2-OHE1:16α-OHE1 in casual samples at baseline and after each treatment phase. RESULTS: After 12 weeks of intervention, the mean (95% CI) urinary 2-OHE1:16α-OHE1 was 4.55 (2.69, 6.42) (p<0.001) higher following EstroSense than placebo adjusted for baseline values. CONCLUSIONS: EstroSense use led to markedly higher urinary 2-OHE1:16α-OHE1 than the placebo, a biomarker associated with a lower risk of breast cancer. REGISTRATION: http://clinicaltrials.gov (NCT02385916).

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.

Effect of a functional fibre supplement on glycemic control when added to a year-long medically supervised weight management program in adults with type 2 diabetes.

PURPOSE: Soluble fibre beneficially affects metabolism but whether it can augment the reductions in glycemia induced through intensive weight management has not been extensively studied. Our objective was to examine the adjunct effect of the soluble viscous fibre PGX® on glycemic control in adults with type 2 diabetes (T2D) enrolled in a year-long medically supervised weight management program. METHODS: In a placebo-controlled, double-blind study, 290 adults with overweight/obesity and T2D were randomized to receive PGX (15-20 g/day) or isocaloric placebo (rice flour, 6.4-8.6 g/day) as an adjunct to intensive weight management for 52 weeks. The primary outcome was change in glycemic control (HbA1c). Other outcome measures included weight loss, blood lipids, blood pressure, cytokines and fecal microbiota. RESULTS: Compared to baseline HbA1c in PGX (7.2 ± 1.1%) and placebo (7.0 ± 0.9%) groups, there was a significant reduction at 16 and 26 weeks, however, only PGX showed a significant absolute reduction of 0.23% at 52 weeks; there were no between-group differences in HbA1c. At 52 weeks, only PGX significantly decreased body weight compared to baseline and reduced waist circumference at all time points. Compared to baseline, only PGX showed a significant reduction in LDL cholesterol at 16 and 26 weeks. PGX significantly increased the relative abundance of Collinsella, Parabacteroides and Roseburia. CONCLUSION: Adding PGX to a weight management program for individuals with T2D provides a sustained reduction in HbA1c compared to placebo. Improvements in other metabolic outcomes suggest that PGX may be a promising adjunct to weight loss programs in patients with T2D. CLINICAL TRIAL: This trial was registered at ClinicalTrials.gov as NCT01644201.

Effect of PolyGlycopleX (PGX) Consumption on Blood Lipid Profiles in Healthy, Low CVD Risk Overweight Adults.

Raised blood lipid levels are associated with a risk of a cardiovascular disease (CVD). Moderate reductions in several CVD factors such as total, low-density lipoprotein (LDL) cholesterol and non-high-density lipoprotein (non-HDL) cholesterol concentrations may be more effective in reducing overall risk than a major reduction in just one. A blind, randomised controlled trial was conducted with 120 healthy overweight (BMI 25⁻30) adults aged 25⁻70 years who were non-smokers, not diabetic and of low risk of cardiovascular disease, as assessed by the Framingham risk equation. Participants consumed 4.5 g PolyGlycopleX (PGX) as softgel capsules (PGXS) or 5 g PGX granules (PGXG) or 5 g rice flour (RF) with meals three times a day for 12 weeks. Total, LDL and non-HDL cholesterol were all significantly reduced (-6%, -5% and -3.5%, respectively) post the PGX granule treatment; however, PGX in softgel capsule form did not affect blood lipid profiles. Daily consumption of PGX granules in overweight low CVD risk adults produced lipid changes indicating a CVD preventative benefit.

Response to Comments by Vuksan V. et al., Nutrients 2017, 9, 398, Regarding an Article by Solah V.A. et al., Nutrients 2017, 9, 149.

n/a.

Erratum: Effect of Fibre Supplementation on Body Weight and Composition, Frequency of Eating and Dietary Choice in Overweight Individuals Nutrients 2017, 9, 149.

n/a.

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.

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, per-protocol analysis [corrected] 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 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 2011.

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.

Effects of a viscous-fibre supplemented evening meal and the following un-supplemented breakfast on post-prandial satiety responses in healthy women.

The post-prandial satiety response and "second-meal effect" of a viscous fibre supplement PolyGlycopleX(®) (PGX(®)) was evaluated in a single-blind, randomised controlled crossover study of 14 healthy adult women. The two hour post-prandial satiety response, expressed as the area under the curve (AUC) of perceived hunger/fullness score versus post-prandial time, of a standardised evening meal with concurrent intake of either PGX softgel or rice flour softgel (control) was determined. On the following morning, after an overnight fast, the four hour satiety response to a standardised breakfast with no softgel supplementation was assessed. A significantly higher satiety response (AUC) to the standard dinner for the PGX-supplemented dinner compared with the control dinner (p=0.001) was found. No significant difference (p=0.09) was observed in the satiety response (AUC) of the breakfast regardless of which supplemented-dinner had been consumed prior, however the p value indicated a trend towards a higher response to the breakfast following the PGX-supplemented dinner. The fullness scores of the breakfast following the PGX-supplemented dinner at 15, 30, 90, 120, 150, 180, 210 and 240min post-prandial were significantly higher than those for the breakfast following the control dinner (p=<0.001, 0.007, 0.009, 0.009, 0.049, 0.03, 0.003 and <0.001 respectively). PGX supplementation at dinner increased the satiety effects of both the dinner itself and the subsequent un-supplemented breakfast; a "second meal effect" indicting the potential for this fibre supplement to induce extended satiety.

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 of the novel polysaccharide PolyGlycopleX® on short-chain fatty acid production in a computer-controlled in vitro model of the human large intestine.

Many of the health benefits associated with dietary fiber are attributed to their fermentation by microbiota and production of short chain fatty acids (SCFA). The aim of this study was to investigate the fermentability of the functional fiber PolyGlyopleX® (PGX®) in vitro. A validated dynamic, computer-controlled in vitro system simulating the conditions in the proximal large intestine (TIM-2) was used. Sodium hydroxide (NaOH) consumption in the system was used as an indicator of fermentability and SCFA and branched chain fatty acids (BCFA) production was determined. NaOH consumption was significantly higher for Fructooligosaccharide (FOS) than PGX, which was higher than cellulose (p = 0.002). At 32, 48 and 72 h, acetate and butyrate production were higher for FOS and PGX versus cellulose. Propionate production was higher for PGX than cellulose at 32, 48, 56 and 72 h and higher than FOS at 72 h (p = 0.014). Total BCFA production was lower for FOS compared to cellulose, whereas production with PGX was lower than for cellulose at 72 h. In conclusion, PGX is fermented by the colonic microbiota which appeared to adapt to the substrate over time. The greater propionate production for PGX may explain part of the cholesterol-lowering properties of PGX seen in rodents and humans.

Dose-response effect of a novel functional fibre, PolyGlycopleX(®), PGX(®), on satiety.

The objective of this research was to determine the dose-response effects of a palatable, viscous and gel forming fibre, PolyGlycopleX(®) (PGX(®)), [(α-D-glucurono-α-manno-ß-D-manno-ß-D-gluco), (α-Lgulurono-ß-D mannurono), (ß-D-gluco-ß-D-mannan)] on satiety, and to gain insight into the underlying mechanisms that lead to appetite inhibition. Healthy subjects (n = 10), aged between 20.3 and 29.2 years, consumed PGX(®), in granular form at 2.5, 5.0 and 7.5 g, and a 5g inulin control, with a standard breakfast. The PGX(®) doses of 2.5 and 7.5 g mixed with water at the start of breakfast increased satiety (iAUC of 140.0 and 157.7, P = 0.025 and 0.001, respectively) compared to the control. The most effective dose (7.5g) was palatable and corresponded to a 34% increase in fullness, measured using a visual analogue scale and incremental area under the curve, and resulted in a delayed postprandial glycaemic response when compared with the control.

Combining sitagliptin/metformin with a functional fiber delays diabetes progression in Zucker rats.

Our primary objective was to determine whether administering the viscous and fermentable polysaccharide PolyGlycopleX (PGX) with metformin (MET) or sitagliptin/metformin (S/MET) reduces hyperglycemia in Zucker diabetic fatty (ZDF) rats more so than monotherapy of each. Glucose tolerance, adiposity, satiety hormones and mechanisms related to dipeptidyl peptidase 4 activity, gut microbiota and, hepatic and pancreatic histology were examined. Male ZDF rats (9-10 weeks of age) were randomized to: i) cellulose/vehicle (control, C); ii) PGX (5% wt/wt)/vehicle (PGX); iii) cellulose/metformin (200  mg/kg) (MET); iv) cellulose/S/MET (10  mg/kg+200  mg/kg) (S/MET); v) PGX (5%)+MET (200  mg/kg) (PGX+MET); vi) cellulose/sitagliptin/MET (5%)+(10  mg/kg+200  mg/kg) (PGX+S/MET) for 6 weeks. PGX+MET and PGX+S/MET reduced glycemia compared with C and singular treatments (P=0.001). Weekly fasted and fed blood glucose levels were lower in PGX+MET and PGX+S/MET compared with all other groups at weeks 4, 5, and 6 (P=0.001). HbA1c was lower in PGX+S/MET than C, MET, S/MET, and PGX at week 6 (P=0.001). Fat mass was lower and GLP1 was higher in PGX+S/MET compared with all other groups (P=0.001). ß-cell mass was highest and islet degeneration lowest in PGX+S/MET. Hepatic lipidosis was significantly lower in PGX+S/MET compared with PGX or S/MET alone. When combined with PGX, both MET and S/MET markedly reduce glycemia; however, PGX+S/MET appears advantageous over PGX+MET in terms of increased ß-cell mass and reduced adiposity. Both combination treatments attenuated diabetes in the obese Zucker rat.

Decreasing cardiovascular risk factors in obese individuals using a combination of PGX® meal replacements and PGX® granules in a 12-week clinical weight modification program.

In this open, clinically based, weight modification program, we determined in six sedentary obese adults (five women; one male; age range 30-62 years) that the combination of a modified calorie diet plus PGX® meal replacement and PGX® supplementation resulted in a significant reduction in several cardiovascular risk factors over a 12-week time period. This included a significant improvement in lipids (-0.98 mmol/l LDL-C), reduction in average weight (-9.2 kg), mean reduction in fat (-4.1%) and an increase in fat-free mass (2.8%).

Changes in visceral adiposity and serum cholesterol with a novel viscous polysaccharide in Japanese adults with abdominal obesity.

OBJECTIVE: Evidence supports the role of dietary fiber in improving metabolic health. PolyGlycopleX (PGX), a viscous functional polysaccharide improves lipidemia and glycemia in healthy adults. Our objective was to examine the effects of PGX on risk factors associated with the metabolic syndrome in Japanese adults with abdominal obesity. DESIGN AND METHODS: Sixty four subjects assigned to 14 weeks of 15 g day(-1) of PGX or placebo were assessed in a randomized, double-blind, placebo-controlled, parallel group trial. At week 0 and 14, primary outcome measures were serum lipids, abdominal adiposity, glucose tolerance and blood pressure. RESULTS: Total and LDL cholesterol were reduced at week 14 with PGX but not placebo (P < 0.05). The reduction in waist circumference at week 14 was greater with PGX versus placebo (P < 0.05). In females, abdominal visceral fat was decreased to a greater extent with PGX versus placebo (P < 0.05). While glucose tolerance worsened with placebo over time, PGX reduced glucose total area under the curve from week 0 to 6 (P = 0.039). Serum concentrations of resistin and IL6 increased slightly in placebo and decreased slightly with PGX . CONCLUSIONS: PGX is a functional fiber that shows promise in reducing risk factors related to the metabolic syndrome in Japanese adults with abdominal obesity.

Meal replacements and fibre supplement as a strategy for weight loss. Proprietary PGX® meal replacement and PGX® fibre supplement in addition to a calorie-restricted diet to achieve weight loss in a clinical setting.

Meal replacements and viscous soluble fibre represent safe and sustainable aids for weight loss. Our purpose was to determine if PGX® meal replacements and PGX(®) fibre complex in combination with a calorie-restricted diet would aid in weight loss in a clinical setting. Fifty-two overweight and obese participants (49 women, 3 men; average age 47.1 years) with a mean body mass index (BMI) of 33.8 ± 6.4 kg/m(2) consumed 57 g of proprietary PGX® meal replacement product at breakfast and another 57 g at lunch for 12 weeks. In addition to the meal replacements, they were also asked to consume 5 g/day of PGX® fibre in the form of granules, powder or capsules together with 250 mlwater. A registered dietician recommended low-fat, low-glycaemic-index foods for snacks and the dinner menus such that each volunteer was consuming a total of 1200 kcal/day. All participants (n = 52) lost a significant amount of weight from baseline (-4.69 ± 3.73 kg), which was further reflected in the reductions in their waist (-7.11 ± 6.35 cm) and hip circumference (-5.59 ± 3.58 cm) over the 12-week study (p < 0.0001). BMI scores (n = 51) were reduced by 1.6 ± 1.4 kg/m(2). The use of PGX® meal replacements and PGX(®) fibre along with a controlled dietary caloric intake is of benefit for short-term weight loss.