What is pgx

Recently, PolyGlycopleX PGX , a novel, highly viscous non-starch polysaccharide complex has been developed for human consumption. In a recent randomised, placebo-controlled trial, PGX was shown to diminish hunger and reduce ad libitum food consumption compared with less viscous fibres cellulose and glucomannan given in meal-replacement drinks.

Subjects were recruited through local newspaper advertisements. Women with a body mass index between 25 and Furthermore excluded were those who scored 9 or more on the restraint scale; 27 or above for uncontrolled eating, or 18 or greater for emotional eating on the Three-Factor Eating Questionnaire-R18V2, validated for Canadian and US obese and non-obese individuals.

The University of British Columbia Research Ethics Committee approved the study and all subjects gave informed consent to participate. PGX has been shown to be safe and well tolerated in rodents 24 and in humans. It can be sprinkled on food before consumption or taken with soup or beverage before meals.

Rice flour was used as a placebo and has been used in other clinical trials for its white colour, neutral taste and hypoallergenicity. Boiling or other forms of moist heat processing is required for rice flour to be effectively digested. The study was a prospective, randomised, double-blind, placebo-controlled crossover trial. The study had two experimental phases with a 3-week washout. Participants completed visual analogue scales VAS questionnaires at specified times see below.

To avoid a second meal effect and to minimise differences in glycogen stores, the night before consumption of the 3-day low-calorie diet, all subjects consumed the same evening meal. On Friday, subjects returned to the clinic to have their compliance assessed, documents reviewed and to have any adverse effects recorded. To assess compliance, subjects kept a log of daily food and study product consumed and returned the product containers for weighing.

Commercially available frozen dinner entrees President's Choice Blue Menu, Loblaw, Ontario, Canada were provided to participants to standardise caloric intake and macronutrient composition. Rating subjective appetite using VAS is a valid and reliable measure of appetite under both experimental and free-living conditions, especially when using a within-subject design, as used in the current study.

Unpalatable—Very palatable. The times of rating were the same every day for both phases; however, to work with participants at various schedules, different start times in the morning were available. VAS were completed before e. All food and water consumed during Phase 1 was recorded and the same amount was provided for Phase 2. Changes in weight over each test period were tested for differences between treatment groups using the Wilcoxon rank sum test.

For compliance, the P -values of differences between the two treatment groups within a single period were calculated from two-sample t -tests; the statistical test for the summary across both periods of data used a linear mixed model approach, which took into consideration that the same participants appeared once on each of the two treatments due to the crossover design.

For VAS score analyses, the area under the curve was analysed on the log scale to meet the distributional assumptions required for the statistical methods. The treatment effect was estimated from a linear mixed-effects model to take into consideration the crossover design of the study; the model was adjusted for phase, treatment, randomised sequence and a within-patient comparison was made to assess the treatment effect.

With the different study days expected to give differences in results, the analysis was carried out by days 1, 2, 3 and on the mean of days 1—3. To analyse VAS scores by time point, a similar linear mixed model was used incorporating terms in the model for treatment, phase, randomised group and time point, and then contrasts used to compare the treatment groups at the different time points.

Statistical testing of the adverse event rates by treatment either overall rates, treatment-related rates or rates for specific types of adverse events was performed using generalised estimating equations logistic regression models. To evaluate whether there was a carryover effect in the second period by the randomised sequences, a standard statistical approach by Jones et al.

For all statistical tests, the significance level was set at 0. All analyses were performed using SAS Version 9. In total, 51 individuals were recruited for the study of which 45 were randomised Table 1.

After Phase 1, five discontinued from the study. Overall, 40 participants completed the entire study; however, only 35 participants were included in the per-protocol analyses as 2 participants deviated from the protocol and 3 reported feeling sick, which might affect subjective appetite ratings. There was no carryover effect in the second period by the randomised sequences. Weight loss was similar between groups over the two phases PGX 1.

The majority of differences in subjective ratings between the placebo and PGX groups at various time points were detected on day 3. PGX supplementation significantly reduced total appetite, desire to eat, hunger, prospective consumption, and it was associated with increased fullness at 2. Hunger was also reduced at 2. Comparison of 2.

Comparison of the 4. Adverse events reported by both treatment groups are summarised in Table 3. There was no statistical difference between the two treatment groups in terms of the adverse events experience of the participants. Furthermore, the overall or treatment-related adverse events were similar for the two treatments.

Parentheses denote the percentage from the total number of participants. Some P -values were not possible to compute due to no events being reported under one of the treatment groups. These results might be particularly helpful in managing obesity, given reports that food intake tends to be less in the morning and greater in the afternoon and highly evening in obese versus normal weight individuals.

Another possibility may be the cumulative effects of PGX over time with the potential for upregulation of gut-satiety hormone gene expression such as proglucagon via fermentation and production of short-chain fatty acids in the large bowel. Soluble fibres that are fermentable by gut microbiota and produce significant quantities of short-chain fatty acids may contribute to appetite regulation by stimulating the release of gut-satiety hormones such as peptide YY PYY and glucagon like peptide To produce an equivalent stimulation of PYY sufficient to promote satiety, obese individuals need to consume a much greater caloric load than their lean counterparts.

Further investigation of a low-calorie diet supplemented with PGX on gut-satiety hormones is thus warranted. Under conditions of fixed energy intake, such as a low-calorie diet, viscous soluble fibres may also alter the viscosity of gastrointestinal content resulting in multiple effects on satiety.

A magnetic resonance imaging study by Marciani et al. Viscous soluble fibres also delay the absorption of nutrients by thickening the unstirred layer at the gut mucosal surface. The GI is a property of carbohydrate-containing food that describes the rise of blood glucose occurring after a meal.

High GI foods are classified as being rapidly digested and absorbed into the bloodstream, resulting in a sharp rise and in a steep decline of blood glucose after consumption, whereas low GI foods are broken down more slowly by a slower rate of digestion and absorption and releasing glucose more gradually into the bloodstream.

Arumugam et al. If however the study foods had a low GI, PGX may not have exerted as significant an effect on satiety. This study was designed to alleviate some potentially confounding variables in appetite research.

The timing of the test phases was scheduled according to participants' menstrual cycle, given that previous research has linked changes in gastrointestinal function, appetite and energy intake to the follicular and luteal phases of menstruation. Although the effect of PGX on ad libitum food intake cannot be concluded, prior research has shown that subjective ratings of appetite appear to be good indicators of motivation to eat and are predictors of actual food intake.

To minimise the effect of palatability on appetite ratings, women who rated the palatability of the meals low were excluded. However, a significant difference in palatability between meals supplemented with PGX and rice flour was observed on all of the three-diet days. Previous research with PGX has not found any significant differences in palatability scores in comparisons with controls.

This difference may be related more to texture than to any gastrointestinal discomforts experienced with PGX, as there was no statistical difference in adverse events reported between PGX and rice flour.

Although palatability affects appetite, 57 , 58 this did not translate into significant differences in subjective appetite scores for days 1 and 2, suggesting that the difference observed on day 3 may have not been due to the palatability of the PGX - supplemented meal.

When designing placebo-controlled trials with PGX, it is difficult to find a comparable inert substance and completely avoid any potentially confounding effect. Uncooked rice flour was found to closely approximate PGX in terms of flavour and texture, and it was thus judged to be a suitable placebo. However, the presence of resistant starches may have produced an increase in fermentation in the control group and dampened the difference in results between the two interventions.

As an initial investigation, this study was performed over 3 days because of the number of VAS questionnaires dispensed and strict adherence required for the food and meal schedule.

It was conducted under free-living conditions so as to mimic people following a structured low-calorie diet in their regular lives. However, this inherently introduced some variability in the participants' environment, occupational and non-occupational activities, which could have resulted in diurnal variations in appetite.

In summary, this study indicates that the supplementation of highly viscous PGX to meals could be a useful weight management aid during a low-calorie diet to help lessen feelings of hunger and to moderate food portions.

Because dietary fiber promotes fullness, researchers examined the effect of PGX on satiety in a group of both men and women. The participants took 5 grams of PGX daily for one week, followed by 10 grams each day for two additional weeks.

Researchers measured levels of peptide YY, an appetite-suppressing hormone, three times during the trial and found PGX significantly increased PYY levels, compared to the control group.

This data suggests PGX may promote fullness and reduce calorie intake by regulating appetite hormones. Although human studies are needed, an animal experiment suggests PGX may help lower triglycerides, according to results published in the April issue of the journal "Nutrition Research.

Researchers discovered PGX significantly decreased the rats' triglyceride levels to close to what they were at baseline. PGX also reduced fat accumulation in the liver, according to the study. Researchers evaluated the safety of taking PGX for 21 days at the maximum dose of 10 grams per day in healthy males and females.

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