Differences in Metabolite Profiles of Dihydroberberine and Micellar Berberine in Caco-2 Cells and Humans-A Pilot Study.

We investigated the pharmacokinetic pathway of berberine and its metabolites in vitro, in Caco-2 cells, and in human participants following the administration of dihydroberberine (DHB) and micellar berberine (LipoMicel®, LMB) formulations. A pilot trial involving nine healthy volunteers was conducted over a 24 h period; blood samples were collected and subjected to Ultra High-Performance Liquid Chromatography-High Resolution Mass Spectrometry (UHPLC-HRMS) analyses to quantify the concentrations of berberine and its metabolites. Pharmacokinetic correlations indicated that berberrubine and thalifendine follow distinct metabolic pathways. Additionally, jatrorrhizine sulfate appeared to undergo metabolism differently compared to the other sulfated metabolites. Moreover, berberrubine glucuronide likely has a unique metabolic pathway distinct from other glucuronides. The human trial revealed significantly higher blood concentrations of berberine metabolites in participants of the DHB treatment group compared to the LMB treatment group-except for berberrubine glucuronide, which was only detected in the LMB treatment group. Similarly, results from in vitro investigations showed significant differences in berberine metabolite profiles between DHB and LMB. Dihydroberberine, dihydroxy-berberrubine/thalifendine and jatrorrhizine sulfate were detected in LMB-treated cells, but not in DHB-treated cells; thalifendine and jatrorrhizine-glucuronide were detected in DHB-treated cells only. While DHB treatment provided higher blood concentrations of berberine and most berberine metabolites, both in vitro (Caco-2 cells) and in vivo human studies showed that treatment with LMB resulted in a higher proportion of unmetabolized berberine compared to DHB. These findings suggest potential clinical implications that merit further investigation in future large-scale trials.

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.

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.

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.

Evaluation of the Metabolite Profile of Fish Oil Omega-3 Fatty Acids (n-3 FAs) in Micellar and Enteric-Coated Forms-A Randomized, Cross-Over Human Study.

This study evaluated the differences in the metabolite profile of three n-3 FA fish oil formulations in 12 healthy participants: (1) standard softgels (STD) providing 600 mg n-3 FA; (2) enteric-coated softgels (ENT) providing 600 mg n-3 FA; (3) a new micellar formulation (LMF) providing 374 mg n-3 FA. The pharmacokinetics (PKs), such as the area under the plot of plasma concentration (AUC), and the peak blood concentration (Cmax) of the different FA metabolites including HDHAs, HETEs, HEPEs, RvD1, RvD5, RvE1, and RvE2, were determined over a total period of 24 h. Blood concentrations of EPA (26,920.0 ± 10,021.0 ng/mL·h) were significantly higher with respect to AUC0-24 following LMF treatment vs STD and ENT; when measured incrementally, blood concentrations of total n-3 FAs (EPA/DHA/DPA3) up to 11 times higher were observed for LMF vs STD (iAUC 0-24: 16,150.0 ± 5454.0 vs 1498.9 ± 443.0; p ≤ 0.0001). Significant differences in n-3 metabolites including oxylipins were found between STD and LMF with respect to 12-HEPE, 9-HEPE, 12-HETE, and RvD1; 9-HEPE levels were significantly higher following the STD vs. ENT treatment. Furthermore, within the scope of this study, changes in blood lipid levels (i.e., cholesterol, triglycerides, LDL, and HDL) were monitored in participants for up to 120 h post-treatment; a significant decrease in serum triglycerides was detected in participants (~20%) following the LMF treatment; no significant deviations from the baseline were detected for all the other lipid biomarkers in any of the treatment groups. Despite a lower administered dose, LMF provided higher blood concentrations of n-3 FAs and certain anti-inflammatory n-3 metabolites in human participants-potentially leading to better health outcomes.

Carbon disulfide as a dopant in photon-induced chemical ionization mass spectrometry.

RATIONALE: The addition of a dopant to an Atmospheric Pressure PhotoIonization (APPI) source of a mass spectrometer has been shown to enhance the degree of analyte ionization. A series of different dopants has been successfully utilized; however, there has been very little published on the characteristics of a good dopant. We have proposed carbon disulfide (CS2) as a novel new dopant based on its absorption cross-section for the VUV photon's energy used and its unique gas-phase ion chemistry, notably the fact that it does not contain a proton. METHODS: The ability of CS2 to enhance the ionization effectiveness of APPI was tested by using a group of compounds that have different proton affinities (PAs) and electron affinities (EAs). These results were compared to results obtained using the commonly used dopants, toluene and anisole. Particular attention was paid to the formation of [M](+) ions relative to [M+H](+) ions. Mass spectra were collected using a Waters Quattro Premier liquid chromatography/tandem mass spectrometry (LC/MS/MS) system equipped with a commercial Photomate™ photoionization source. RESULTS: The results show that CS2 increases the ionization efficiency of most of the analytes studied in this work comparably to toluene and anisole. CS2 promotes both ionization routes of [M](+) and [M+H](+). In addition, due to the higher ionization energy (IE) of CS2 (10.01) compared to the IEs of toluene (8.83) and anisole (8.20), CS2 can enhance the ionization efficiency of analytes that cannot be enhanced with toluene and anisole. CONCLUSIONS: We have determined that CS2 is a viable dopant for use in APPI sources. For some analytes, significant [M+H](+) ion signals are observed; therefore, the donated proton must come from either water clusters or solvents. In addition, CS2 promotes the ionization of analytes with low PAs and higher IEs than that of toluene and anisole.

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.

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).

Characterization and Pharmacokinetic Assessment of a New Berberine Formulation with Enhanced Absorption In Vitro and in Human Volunteers.

Berberine is a plant-origin quaternary isoquinoline alkaloid with a vast array of biological activities, including antioxidant and blood-glucose- and blood-lipid-lowering effects. However, its therapeutic potential is largely limited by its poor oral bioavailability. The aim of this study was to investigate the in vitro solubility and Caco-2 cell permeability followed by pharmacokinetic profiling in healthy volunteers of a new food-grade berberine delivery system (i.e., Berberine LipoMicel®). X-ray diffractometry (XRD), in vitro solubility, and Caco-2 cell permeability indicated higher bioavailability of LipoMicel Berberine (LMB) compared to the standard formulation. Increased aqueous solubility (up to 1.4-fold), as well as improved Caco-2 cell permeability of LMB (7.18 × 10-5 ± 7.89 × 10-6 cm/s), were observed when compared to standard/unformulated berberine (4.93 × 10-6 ± 4.28 × 10-7 cm/s). Demonstrating better uptake, LMB achieved significant increases in AUC0-24 and Cmax compared to the standard formulation (AUC: 78.2 ± 14.4 ng h/mL vs. 13.4 ± 1.97 ng h/mL, respectively; p < 0.05; Cmax: 15.8 ± 2.6 ng/mL vs. 1.67 ± 0.41 ng/mL) in a pilot study of healthy volunteers (n = 10). No adverse reactions were reported during the study period. In conclusion, LMB presents a highly bioavailable formula with superior absorption (up to six-fold) compared to standard berberine formulation and may, therefore, have the potential to improve the therapeutic efficacy of berberine. The study has been registered on ClinicalTrials.gov with Identifier NCT05370261.

Sitagliptin reduces hyperglycemia and increases satiety hormone secretion more effectively when used with a novel polysaccharide in obese Zucker rats.

The novel polysaccharide (NPS) PolyGlycopleX (PGX) has been shown to reduce glycemia. Pharmacological treatment with sitagliptin, a dipeptidyl peptidase 4 (DPP4) inhibitor, also reduces glycemia by increasing glucagon-like peptide-1 (GLP-1). Our objective was to determine if using NPS in combination with sitagliptin reduces hyperglycemia in Zucker diabetic fatty (ZDF) rats more so than either treatment alone. Male ZDF rats were randomized to: 1) cellulose/vehicle [control (C)]; 2) NPS (5% wt:wt)/vehicle (NPS); 3) cellulose/sitagliptin [10 mg/(kg · d) (S)]; or 4) NPS (5%) + S [10 mg/(kg · d) (NPS+S)]. Glucose tolerance, adiposity, satiety hormones, and mechanisms related to DPP4 activity and hepatic and pancreatic histology were examined. A clinically relevant reduction in hyperglycemia occurred in the rats treated with NPS+S (P = 0.001) compared with NPS and S alone. Blood glucose, measured weekly in fed and feed-deprived rats and during an oral glucose tolerance test, was lower in the NPS+S group compared with all other groups (all P = 0.001). At wk 6, glycated hemoglobin was lower in the NPS+S group than in the C and S (P = 0.001) and NPS (P = 0.06) groups. PGX (P = 0.001) and S (P = 0.014) contributed to increased lean mass. Active GLP-1 was increased by S (P = 0.001) and GIP was increased by NPS (P = 0.001). Plasma DPP4 activity was lower in the NPS+S and S groups than in the NPS and C groups (P = 0.007). Insulin secretion and ß-cell mass was increased with NPS (P < 0.05). NPS alone reduced LDL cholesterol and hepatic steatosis (P < 0.01). Independently, NPS and S improve several metabolic outcomes in ZDF rats, but combined, their ability to markedly reduce glycemia suggests they may be a promising dietary/pharmacological co-therapy for type 2 diabetes management.

Effects of added PGX®, a novel functional fibre, on the glycaemic index of starchy foods.

The development of lower-glycaemic index (GI) foods requires simple, palatable and healthy strategies. The objective of the present study was to determine the most effective dose of a novel viscous fibre supplement (PGX®) to be added to starchy foods to reduce their GI. Healthy subjects (n 10) consumed glucose sugar (50 g in water × 3) and six starchy foods with a range of GI values (52-72) along with 0 (inert fibre), 2.5 or 5 g granular PGX® dissolved in 250 ml water. GI testing according to ISO Standard 26,642-2010 was used to determine the reduction in GI. PGX® significantly reduced the GI of all six foods (P < 0.001), with an average reduction of 19 % for the 2.5 g dose and 30 % for the 5 g dose, equivalent to a reducing the GI by 7 and 15 units, respectively. Consuming small quantities of the novel functional fibre PGX®, mixed with water at the start of a meal, is an effective strategy to reduce the GI of common foods.

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.

Genotoxicity studies of PolyGlycopleX (PGX): a novel dietary fiber.

PolyGlycopleX (PGX), a novel dietary fiber, produces no mutagenic effects in bacterial tester strains Salmonella typhimurium TA 98, TA 100, TA 1535, and TA 1537 and Escherichia coli WP2 uvrA at concentrations of 0.316, 1.00, 3.16, 10.0, 31.6, and 100 microg/plate. No biologically relevant increases in revertant colonies of any of the 5 strains are observed at any concentration; however, a reduction at 100 microg/plate in TA 1537 is noted. PGX, analyzed for polychromatic erythrocyte micronuclei induction in mice following a single 1x, 0.5x, and 0.2x maximum tolerable dose intraperitoneal treatment, produces no biologically relevant increase in any dose group. Males at 1x maximum tolerable dose show a reduction of micronuclei-containing cells. High-dose animals show signs of systemic toxicity, including a reduction of spontaneous activity, rough fur, palpebral closure, prone position, and constricted abdomen. These genotoxicity studies show PGX to be nonmutagenic in both the Ames bacterial reverse mutation assay and the mammalian erythrocyte micronucleus test.

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.

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.

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 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.