RecruitingACTRN12617000960358

Fibre supplementation to decrease hunger, improve chronic disease risk factors and weight loss in overweight and obese children.

PGX® supplementation to improve satiety, glucose, HbA1c, lipid status and weight loss in overweight and obese children.


Sponsor

Curtin University

Enrollment

70 participants

Start Date

Apr 3, 2019

Study Type

Interventional

Conditions

Summary

Aims: The aim of this study is to examine the effect of PolyGlycopleX® (PGX®) supplementation on metabolic risk factors in overweight and obese children. Background: The number of overweight children in Australia, Canada and the US has doubled in recent years, with a third considered either overweight or obese. There is considerable evidence childhood obesity can result in orthopaedic complications, sleep apnoea and hepatic steatosis, cardiovascular disease risk factors, type 2 diabetes and psychosocial problems, including low self-esteem and depression. Childhood obesity usually progresses into adulthood, leading to earlier development of chronic diseases such as type 2 diabetes. As a consequence, early interventions in overweight children are required urgently. High-fibre intake has been shown to reduce the risk of metabolic syndrome, cardiovascular disease and type 2 diabetes in adults. Studies in adults have demonstrated that fibre supplementation can benefit many components of the metabolic syndrome (MS) such as glucose levels and insulin response, blood pressure, as well as lipid profile, thereby reducing chronic disease. However, the effect of fibre supplementation on MS components in children is currently unknown. Supplementation with the novel viscous polysaccharide PGX® (a listed medicine with the TGA, with the active ingredient known as Alginate-konjac-xanthan polysaccharide complex) in adults has shown beneficial effects on weight gain, satiety, lipids, glycaemic response and insulin sensitivity but there have been no studies on the effects in children. Therefore, the aim of this study is to investigate the role of 5g PGX® supplementation (plain powder added to 250 mL milk and one spoon of sugar-free chocolate powder) compared to a placebo, for 16 weeks on fasting glucose, HbA1c, lipids, BMI for age percentile, body composition and satiety in overweight/obese children aged 9-13 years. Collectively, PGX® supplementation could be promoted to overweight and obese children as an aid to weight loss and management by increasing satiety and suppressing excess food intake. Therefore, a simple strategy of PGX® supplementation may offer an easy solution to improvements in metabolic syndrome in children without the need for other nutrient modification. Study Proposal: Seventy overweight and obese children will consume 10g PGX® or placebo supplement (as a divided dose of 5g) for 16 weeks. Fasting measurements of various metabolic risk factors such as glucose, glycated haemoglobin (HbA1c) and lipids will be taken at 0 and 16 weeks. Height, body weight, body composition, waist, hip, blood pressure, body water and satiety will be measured at 0, 8 and 16 weeks.


Eligibility

Sex: Both males and femalesMin Age: 9 YearssMax Age: 13 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a special type of dietary fibre supplement called PGX (PolyGlycopleX) can help overweight and obese children feel less hungry, improve their blood sugar and cholesterol levels, and support healthy weight management. Many overweight children grow up to have type 2 diabetes and heart disease. This fibre supplement has worked well in adults but has never been tested in children. Children in the study will take a fibre powder mixed into milk daily for 16 weeks. You may be eligible if: - Your child is between 9 and 13 years old - Your child has a BMI above the 85th percentile for their age and sex (overweight or obese) You may NOT be eligible if: - Your child takes medications or has conditions affecting appetite or metabolism - Your child uses steroids or medicines that affect cholesterol - Your child takes warfarin (a blood thinner) - Your child has diabetes, thyroid problems, or recent heart problems - Your child has gastrointestinal problems or difficulty swallowing - Your child has a dairy allergy or lactose intolerance - Your child has liver or kidney failure Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This will be a randomised, double blind, parallel design study over a 16-week period. The intervention will consist of 2 x 5g sachets (total daily dose) of PGX® (Alginate-konjac-xanthan polysaccharide

This will be a randomised, double blind, parallel design study over a 16-week period. The intervention will consist of 2 x 5g sachets (total daily dose) of PGX® (Alginate-konjac-xanthan polysaccharide complex) (InovoBiologic, Inc., Calgary, Canada) in a granulated form. Participants will only take half of each sachet (2 x 2.5g) for a week before taking the full dose to allow time to adjust to the supplement. Participants will be instructed to mix 5g of the PGX® powder with either 250 mL of milk and one spoon of sugar-free chocolate powder (provided to participants) twice daily (in place of two serves of dairy in participants’ usual diets), 5-10 minutes before meals (breakfast and dinner). In addition, each child should consume at least 250 mL water after taking the supplement. Adherence will be monitored by sachet return.


Locations(1)

WA, Australia

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ACTRN12617000960358